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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

413 Study Matches

A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma

This is an early study of a new drug, RGDCRAdCOX2F, as a single tumor injection in persons with adenocarcinoma of the pancreas. The main goal of the study is to find a safe dose of the study drug.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021119
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Inclusion Criteria:

• documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes
• one prior line of therapy is permitted
• normal cardiac and pulmonary function
• participants with partners of childbearing potential must be willing to use at least two forms of effective birth control
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• other types of pancreatic cancer
• history of human immunodeficiency virus (HIV) infection
• history of or active acute or chronic active hepatitis B or C infection
• taking 10mg/day or more of prednisone for more than one week
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Pancreas, Pancreatic Cancer
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A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis

The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. We will also check if the study drug works to improve your kidney function, if has an impact on your daily life and the amount of the study drug in your blood over a period of time (called pharmacokinetics)

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015869
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Inclusion Criteria:

• at least 12 years of age
• for people with Alport Syndrome: confirmed diagnosis by genetic testing and /or kidney biopsy
• for primary Focal Segmental Glomerulosclerosis (FSGS), (without any identifiable cause, and where the FSGS is confirmed by renal biopsy) or FSGS where there is documentation of a genetic mutation in a podocyte protein
• female patients, as well as, female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study (90 days after the last dose of study medication)
• males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug
• contact study staff for additional criteria
Exclusion Criteria:

• uncontrolled diabetes mellitus as evidenced by an HbA1c greater or equal to 11%
• uncontrolled high blood pressure
• moderate or severe liver impairment
• BMI greater than 40
• women who are pregnant or breast feeding
• additional exclusion criteria apply (study staff will review)
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Alport Syndrome, Focal Segmental Glomerulosclerosis
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Physiological Monitoring of Participants with Chronic Pain Feasibility Study

We are asking people to participate in this study to help us learn more about how physiology (heart rate, sweating, temperature, etc.) of people with pain conditions changes based on perceived pain level. The goal is to use this information to help develop a new medical device designed to help better manage chronic pain, although we are only collecting information at this time, and there will be no treatment provided as part of this study. We expect that people will be in this research study for a maximum of 2 weeks.

Principal Investigator: Beth Groenke
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019112
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Inclusion Criteria:
-18-90 years old
• diagnosed with painful peripheral neuropathy
• have experienced pain for at least 3 months
Conditions: Bone, Joint & Muscle, Dentistry
Keywords: Clinics and Surgery Center (CSC), painful peripheral neuropathy, healthy controls
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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.

Principal Investigator: Sayeed Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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)
Conditions: Digestive & Liver Health
Keywords: Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC), fatty liver, gastrectomy, sleeve, sleeve gastrectomy, weight loss
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Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease (Le-Na)

This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The study entails 2 visits over a 3-month period. On enrollment, participants will be scheduled for the 2 visits, during which fasting blood samples will be collected.

Principal Investigator: Reena Kartha
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013672
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Inclusion Criteria:

• ages 18 to 80
• healthy volunteers without any known diagnosis
Exclusion Criteria:

• hematological cancer or other uncontrolled medical conditions
Conditions: Rare Diseases
Keywords: Gaucher Disease, Healthy Volunteers
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Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD (NExT)

We are doing this study to see if we can improve the standard treatment for OCD, Exposure with Response Prevention, by pairing it with Transcranial Magnetic Stimulation to the parts of the brain that cause OCD symptoms.

Principal Investigator: Christine Conelea
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020646
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Inclusion Criteria:

• 12 to 21 years old
• right-handed
• currently have OCD symptoms
Exclusion Criteria:

• inability to have a MRI
• left-handed
• study staff will review additional exclusion criteria
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: Obsessive-compulsive disorder, OCD, psychology, therapy, TMS, transcranial magnetic stimulation
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First Carpometacarpal Osteoarthritis Evaluation: Determining the Concurrent Validity and Test-Retest Reliability of the Thumb Disability Index (TDX) and Test-retest Reliability of Thumb Position Sense-Error using the Intermetacarpal Distance (IMD) Method

We are studying different questionnaires used to measure symptoms and activity limitations that are linked to thumb arthritis. We are also studying ways to measure thumb position sense in persons with thumb arthritis.

Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006741
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Inclusion Criteria:

• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
Exclusion Criteria:

• received steroid injection treatment in the past 3 months
• history of CMC joint replacement
• nerve problems in the wrist or hand
• women who are pregnant
• unable to speak English
Conditions: Arthritis & Rheumatic Diseases
Keywords: Arthritis, CMC, CMC/Carpometacarpal, Osteoarthritis
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MT2023-38 Monitoring of Immune Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies

The purpose of this research is to collect and store specimens and information about the recovery of the immune system following a stem cell transplant (HCT) or immunotherapy to treat a cancer or blood disease. Samples from many people are being collected and stored so they can be used for research now and in the future.

Principal Investigator: Jeffrey Miller, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021493
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Inclusion Criteria:

• planning to have a Hematopoietic Cell Transplant (HCT), gene therapy or other cell therapy or immunotherapy
• allogeneic related donors
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cell therapy, gene therapy, HCT, Hematopoietic Cell Transplant, immunotherapy
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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.

Principal Investigator: Ryan Demmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Diabetes & Endocrine
Keywords: Prediabetes, elevated blood glucose, impaired glucose, blood sugar, obesity, Hemoglobin A1c, exercis
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors&#13;&#10;for Stroke Prevention and Recovery (ASPIRE)

This study will compare the effects of apixaban to aspirin in patients who have atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Principal Investigator: Oladi Bentho
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000694
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Inclusion Criteria:

• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
Exclusion Criteria:

• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
• contact study staff for additional exclusion criteria
Conditions: Brain & Nervous System, Heart & Vascular
Keywords: Anticoagulation, Atrial Fibrillation (AF), CVA, ICH, Intracerebral Hemorrhage, Stroke
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MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016450
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Inclusion Criteria:

• hematological cancer needing stem cell transplant
• 60 years old or younger
Exclusion Criteria:

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Conditions: Cancer
Keywords: Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)

This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023797
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Inclusion Criteria:

• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), non-small cell lung cancer, NSCLC
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An Open-Label, Pilot Clinical Trial To Test The Efficacy Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

Principal Investigator: Cyrus Jahansouz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023336
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Inclusion Criteria:

• 18 to 75 years old
• having surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) and don't expect to have chemotherapy or diverticulitis
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant
• history of celiac disease
• receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: bowel resection, bowel surgery, Clinics and Surgery Center (CSC), colon cancer
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Development of a RET-Specific Proteomic Assay from Circulating Tumor Cells in Lethal Prostate Cancer

The goal of this study is to find a special protein in the blood of individuals with serious prostate cancer. Special tests look for this protein in their blood while they are getting their regular cancer treatments.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023289
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Inclusion Criteria:

• diagnosis of metastatic castration resistant prostate cancer receiving a standard-of-care systemic therapy (e.g. abiraterone acetate, enzalutamide, darolutamide, or chemotherapy).
Exclusion Criteria:

• known HIV positivity and/or active Hepatitis B based on medical history
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), MCRPC, metastatic castration resistant prostate cancer
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Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core

The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Principal Investigator: Scott Cooper
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1611M00822
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Inclusion Criteria:

• age 21 years and older
• diagnosis of Parkinson's disease
• candidate for DBS
Exclusion Criteria:

• diagnosis of dementia
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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HM2024-11: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLATUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA

The purpose of this study is to compare the efficacy and safety of glofitamab, a novel cluster of differentiation (CD) 20/CD3 bispecific antibody, in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola‑R‑CHP) versus Pola‑R‑CHP in patients with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022042
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Inclusion Criteria:

• 18 to 80 years old
• have not received any treatment for Large B-Cell Lymphoma
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior solid organ transplantation
• history of significant cardiovascular disease
• current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• clinically significant liver disease
• chronic hepatitis B infection, hepatitis C, or HIV
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Large B-Cell Lymphoma, LBCL, lymphoma
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Phase I Clinical Trial of Cell Based Therapy for Duchenne Muscular Dystrophy

This study aims to find out whether MyoPAXon, a genetically modified cellular therapy treatment, is safe to give to patients with Duchenne Muscular Dystrophy (DMD), and whether it has any positive effect on their disease. It will also determine how much MyoPAXon is safe to give to a person at one time.

Principal Investigator: Peter Kang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023008
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Inclusion Criteria:

• diagnosed with Duchenne muscular dystrophy (DMD) and non-ambulatory
• age 18 or older
• off investigational treatments for at least 30 days
Exclusion Criteria:

• presence of HLA antibodies directed toward HLA antigens on MyoPAXon
• active treatment with another investigational therapy
• known allergy to MyoPAXon components
Conditions: Bone, Joint & Muscle
Keywords: Clinics and Surgery Center (CSC), DMD, Duchenne Muscular Dystrophy, Muscular Dystrophy
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A Phase 1B/2 pan-tumor, open-label study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXD) in subjects with recurrent or metastatic solid tumors (IDeate-Pantumor02)

The purpose of this study is to learn more about an investigational drug called ifinatamab deruxtecan (I-DXd; DS-7300. It is being studied to see if it is safe, and if cancer improves while taking it. I-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumor cells to deliver chemotherapy directly to tumor cells while sparing healthy cells.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022970
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Inclusion Criteria:

• disease progression on or after the previous standard-of-care regimen for advanced/metastatic cancer
• unable to do strenuous activity but able to walk and do work of a sedentary nature, e.g., light house work, office work
• additional criteria required based on the type of cancer (pancreatic, breast, bladder, etc.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
• clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Conditions: Cancer
Keywords: Cancer, Recurrent or Metastatic Solid Tumors, Clinics and Surgery Center (CSC)
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A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1) (PRIOH-1)

The purpose of this research study is to look at the safety and effectiveness of pritelivir given orally (by mouth for a maximum of 42 days) for people with an impaired immune system who have recurrent lesions caused by the form of HSV that does respond to treatment with acyclovir.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020605
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Inclusion Criteria:

• at least 16 years old
• immunocompromised or body is unable to fight off infection
• have lesions that can been seen in order to determine if they are healing
• willing to use highly effective birth control
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history or current evidence of gastrointestinal malabsorption
• on hemodialysis for any reason and end stage renal disease (ESRD)
• women who are pregnant or breastfeeding
• unable to communicate with study staff
Conditions: Rare Diseases, Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), Herpes, Herpes Simplex Virus, HSV Infection
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Vibrotactile stimulation of the larynx to treat unexplained chronic cough

This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.

Principal Investigator: Stephanie Misono
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012174
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Inclusion Criteria:

• adults aged 18-80
• more than 8 weeks of non-productive cough
• chest x-ray or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available)
• clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinus or nasal issue is not the reason for the cough
• able to read and speak English
Exclusion Criteria:

• current smoker or quit less than 3 months ago
• infectious cause for cough (e.g., TB, pertussis, COVID)
• history of known or suspected aspiration pneumonia
• recent intubation/neck surgery (within 8 weeks)
• neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA)
• untreated carotid artery disease
• electronic implants (e.g., pacemaker)
• specific medications (study staff will discuss)
• anticipate use of new medications to treat the cough during the period of the study
• currently having speech therapy for cough
• BMI > 40 (for transmission of VTS through soft tissue)
• allergy to adhesives
• drug/alcohol dependency or abuse
• pregnant
• without regular access to wifi and internet
Conditions: Breathing, Lung & Sleep Health, Ear, Nose & Throat
Keywords: chronic cough, cough, larynx, vibrotactile stimulation, Clinics and Surgery Center (CSC)
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Seasonal influenza vaccine high dose boosting in solid organ transplant recipients

We know that patients who have undergone a solid organ transplant are at higher risk for severe influenza infections and may not develop a robust antibody response to a single dose of the influenza vaccine. The purpose of this study is to better understand the body’s response to two doses of the high-dose influenza vaccine compared to one dose during an influenza season.

Principal Investigator: Lauren Fontana
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017687
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Inclusion Criteria:

• at least 18 years old
• history of a solid organ transplant (liver, lung, heart, kidney, pancreas) at least 1 year before starting the study
Exclusion Criteria:

• women who are pregnant
• received ATG or carfilzomib in the past 3 months
• received rituximab or basiliximab in the past 3 months
• prednisone dose is greater than 20mg/ day
• history of a severe allergy to influenza vaccine (e.g., Guillain-Barré syndrome, anaphylaxis, or angioedema)
• have received the influenza vaccine for the current season
Conditions: Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), influenza, influenza vaccine, Solid organ transplant
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Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease

A pilot study looking at an adult-based non-pharmacologic interventional trial in collaboration with psychologist who has expertise in cognitive behavioral therapy (CBT) for adolescents with chronic disease and intellectual disability and developing processes towards independence in non-Sickle Cell Disease settings.

Principal Investigator: Alexander Boucher
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018692
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Inclusion Criteria:

• 18 to 24 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
Exclusion Criteria:

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Conditions: Blood Disorders, Mental Health & Addiction
Keywords: SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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Mechanisms and effects of pallidal deep brain stimulation on levodopa resistant motor signs in Parkinson's disease; Udall Project 2, Aim 2

We hope to identify patterns in the brain that may be related to symptoms of PD, such as problems with walking. We are also testing different stimulation settings to see if they might be more effective than the settings that are currently used for treatment. This research may aid in our understanding of PD and how to treat it more effectively with DBS.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016988
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Inclusion Criteria:

• receiving DBS therapy in for treatment of Parkinson's Disease (PD)
• implanted with Medtronic Percept DBS system
• at least 3 months since initial activation of the DBS
Exclusion Criteria:

• musculoskeletal disorders that significantly affect the ability to perform the motor tasks
• dementia or cognitive impairment
• other significant neurological disorders
• post-operative complications or adverse effects of the DBS stimulation
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001945
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Inclusion Criteria:

• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:

• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Endometrial Carcinoma, endometrial intraepithelial neoplasia (EIN)
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MT2013-06C : Treatment of graft Failure after HSCT

The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients undergoing a second transplant using a haploidentical donor, an unrelated donor or umbilical cord blood. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Principal Investigator: Troy Lund
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1404M49341
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Inclusion Criteria:

• patients with primary or secondary HSCT graft failure
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• uncontrolled infection at the time of transplant
• patients with Fanconi Anemia or other DNA breakage syndromes
Keywords: Clinics and Surgery Center (CSC), Failure, Hematopoietic Stem Cell Transplantation, HSCT
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Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Principal Investigator: Ida-Arlaine Fonkoue
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014457
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Inclusion Criteria:

• female
• 18 years and older
• pre-menopausal
• must have experienced a past trauma, with or without PTSD Diagnosis
Exclusion Criteria:

• pregnant or breastfeeding
• severe traumatic brain injury
• hypertension
• diabetes
• heart disease
• vascular disease
• illicit drug use within the past 6-months prior to participation
• inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3
Conditions: Mental Health & Addiction, Women's Health
Keywords: Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Principal Investigator: Ashish Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1601M82901
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Inclusion Criteria:

• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Conditions: Cancer
Keywords: Neuroblastoma
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Developing and pilot testing an intervention to reduce household shisha smoke exposure within Somali homes

In this study, we want to find out more about secondhand smoke from shisha smoking in the home. We want to help families learn more about the risks of shisha smoke in the home and find ways to stop smoking at home.

Principal Investigator: April Wilhelm
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00021642
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Inclusion Criteria:

• families who identify as Somali American
• have one or more children between 6 months and 18 years of age in the home
• have at least one adult who uses shisha at home
• families with other forms of tobacco use in addition to shisha use will be included
Exclusion Criteria:

• inability or unwillingness to complete all study procedures
Conditions: Cancer, Community Health
Keywords: hookah, shisha, smoking
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CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL (CREST-2) PROTOCOL (CREST-2)

CREST-2 is a parallel trial to compare carotid endarterectomy + intensive medical management (IMM) vs IMM alone, and carotid artery stenting plus IMM vs IMM alone in patients with asymptomatic carotid stenosis >70%.

Principal Investigator: Andrew Grande
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000106
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Inclusion Criteria:

• patients at least 35 years old
• confirmed diagnosis of carotid stenosis
• no history of stroke or TIA on the side of the stenosis in the past six months
Exclusion Criteria:

• other significant medical diagnosis (study staff will review)
• taking anticoagulants
• specific exclusion criteria exist for stent and surgery (contact study staff for more information)
Conditions: Heart & Vascular
Keywords: Carotid Stenosis
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GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

Principal Investigator: Paolo Goffredo
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001813
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Inclusion Criteria:

• at least 18 years old
• able to tolerate giving a blood specimen of up to 60 cc
• willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• people who have untreated colon cancer OR have previously removed adenomas, OR have a family history of colon cancer OR have a current positive screening stool test in the past 12 months that hasn't been evaluated
• Healthy Controls: have no history of finding polyps, no family history, or negative colorectal cancer screening test (if performed) within past 12 months
Exclusion Criteria:

• people who have had surgery, radiation, or chemotherapy for their current colorectal cancer or any other cancer
• history or clinically active Inflammatory Bowel Disease
• HIV or chronic active viral hepatitis
• history of cancer in the past 3 years (except minor skin, cervical, or endometrial)
• active chemotherapy or radiation treatment for any purpose
Conditions: Cancer, Digestive & Liver Health
Keywords: Colon Cancer, Colon Cancer, Colon Cancer Screening, Colorectal Cancer
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