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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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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
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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A Pilot Study of a Portable Head-Only MRI Scanner

This study is to investigate, validate and address remaining technical challenges of new imaging techniques used on a portable MRI machine. The research study consists of a one-time study visit that could last approximately 2.5 hours.

Principal Investigator: Michael Garwood, PhD (Professor)
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024939
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• able to consent for self
• free of contraindications for MRI
Exclusion Criteria:

• currently pregnant
• extremely claustrophobic
Conditions: Community Health
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Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

The goal of this study is to evaluate the effectiveness of elacestrant compared to standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC097
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ER-positive, HER2-negative breast cancer without evidence of recurrence or distant metastases
• considered to be at high risk when cancer was initially diagnoses
• have received at least 24 months but not more than 60 months of endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• inflammatory breast cancer
• history of prior invasive breast cancer
• history of another cancer in the past 3 years
• have had more than a 6-month continuous interruption of endocrine therapy or who are off currently off endocrine therapy more than 6 months
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Breast Cancer
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10,000 Families Study

The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

Principal Investigator: Jen Poynter
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00000877
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Conditions: Cancer, Microbiota, Prevention & Wellness
Keywords: Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS, D2D
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Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary symptoms of Long COVID (REVERSE-LC) (REVERSE-LC)

The purpose of this study is to understand if a drug called baricitinib can help with thinking and memory problems after COVID-19 infection for people suffering with Long COVID. Some people have thinking and memory problems along with possible difficulty breathing, a racing heart, dizziness, and/or fatigue after COVID-19 called Long COVID. This includes things like having a hard time remembering people’s names, managing money, or keeping a job. For some patients, these issues may last several years. We still do not understand why these problems happen and why they last longer in some people. This study will look at the changes in brain function, heart function, and daily activities after taking baricitinib or placebo for people who experience Long COVID.

Principal Investigator: Carolyn Bramante
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022496
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• documented COVID infection 6 or more months prior
• clinical evidence of Long COVID such as fatigue, chills, post-exertional malaise, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance, chest pain, palpitations, shortness of breath, cough, fainting spells, muscle aches, joint pain, nausea, diarrhea
• symptoms must have started after January 2020 and be present for at least 6 months prior starting the study
• symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• severe cognitive, physical, or psychological disability preventing participation
• currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study
• admission to an ICU for treatment of acute COVID-19 infection
• cancer diagnosis in the past 5 years
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Community Health, Infectious Diseases
Keywords: Coronavirus Infections, COVID-19, Long Covid

Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy

This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests.

Principal Investigator: Meredith Wise
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023022
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• able to understand, speak, read, and write in English
• have undergone hysterectomy, or plan to have a hysterectomy
• people who are transgender and gender diverse
Exclusion Criteria:

• on the study’s community advisory board
Conditions: Cancer, Community Health
Keywords: Cancer screening, hysterectomy, uterus
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PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE)

More than 65% of people with lower extremity peripheral artery disease (PAD) are overweight or obese. Overweight or obese people with PAD have greater functional impairment and faster functional decline than normal weight people with PAD. Walking exercise is first line therapy to improve walking performance in PAD. However, our NHLBI-funded observational longitudinal study of functional decline in PAD showed that overweight and obese PAD participants who combined weight loss with walking exercise had significantly less functional decline than those who walked for exercise but did not lose weight. Therefore, we hypothesize that among people with PAD who are overweight or obese, a weight loss intervention combined with exercise will improve walking ability more than exercise alone. However, the effects of intentional weight loss in overweight or obese people with PAD are unknown and may not be beneficial if weight loss exacerbates PAD-related sarcopenia. Behavior change that achieves sustained weight loss is particularly challenging in older obese people with chronic disease. Therefore, among people with PAD and BMI>28 kg/m2, we will conduct a randomized clinical trial to test the hypothesis that a weight loss intervention combined with walking exercise achieves greater improvement in functional performance than exercise alone at 12-month follow-up.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000513
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of Peripheral Artery Disease (PAD) with leg symptoms
• BMI 25kg/m2 or more
Exclusion Criteria:

• above or below knee amputation, critical limb ischemia, or wheelchair confinement
• walking is limited by a condition other than PAD
• heart attack or stroke in the past 3 months
• medical or mental health disease that will interfere with study participations (study staff will review)
• currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• unwilling/unable to use a smart phone and unwilling to attend weekly study sessions
• unable to speak English
Conditions: Heart & Vascular
Keywords: aging, cocoa, intercede, pad, peripheral arterial disease, peripheral artery disease, prove
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REFORM-HF. REducing Fluid Overload using Renal Independent systeM in Heart Failure Patients (REFORM-HF)

This research study is designed to evaluate a new treatment approach for patients with chronic heart failure. This study will assess the effectiveness and safety of a new medical device, the AquaPass system, in managing the accumulation of fluids in the body that persists despite standard medical treatment. The purpose of this study is to understand if the use of the AquaPass System with medication treatment results in increased fluid removal compared to only regular medication treatment.

Principal Investigator: Tamas Alexy
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022887
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of heart failure NYHA Class II, III who is congested and not responding to usual treatment such as 80mg of lasix (or another diuretic) per day
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• acute worsening of heart failure needing care in the ICU
• arrhythmia, infection, or other medical condition that is causing acute illness
• lower body skin problems (open wounds, ulcers, infections)
• severe peripheral artery disease
• women who are pregnant, breast feeding, or planning to get pregnant during the study period
Conditions: Heart & Vascular
Keywords: Heart Failure, CHF
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Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery. We expect that people will be in this research study for 3-6 months depending on the timing of surgery and postoperative visits. The number of preoperative and postoperative visits, physician exams, scans, X-rays, and laboratory tests for preparation for surgery or after the surgery does not change because of this study.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020255
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• having bowel diversion urologic surgery
Exclusion Criteria:

• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Conditions: Kidney, Prostate & Urinary
Keywords: bowel diversion urologic surgery, ileostomy, stoma
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Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease

The purpose of this study is to examine brain activity associated with movement in people with Parkinson’s disease, and the relationship of this brain activity to problems with moving and thinking. Brain activity will be recorded using a cap with EEG sensors attached and/or by recording brain signals from your deep brain stimulator (Medtronic PerceptTM device). We will look at brain activity associated with balance, walking, and movements of your arms or legs.

Principal Investigator: Sommer Huffmaster
Age Group: 18 years and over
IRB Number: STUDY00023279
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• age 21-75
• able to walk independently without the use of an assistive device (e.g. cane) for 50 meters (165 feet)
• have a Medtronic Percept TM Device implanted
• at least 3 months since the initial activation of the neurostimulator
Exclusion Criteria:

• dementia of any cause
• history of musculoskeletal disorders that significantly affect walking or movement of limb(s) that would affect the participation
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Freezing Gait, Parkinson's Disease, PD
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MT2018-19: COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

This partially randomized phase III trial studies iobenguane I-131 or ALK Inhibitor Therapy and standard therapy in treating younger patients (365 days to 30 years of age) with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000265
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
• Diagnosis: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
• The following disease groups are eligible: INRG Stage M & MYCN amplification or age > 547 days OR INRG Stage MS disease with MYCN amplification OR INRG Stage L2 disease with MYCN amplification
Exclusion Criteria:

• Patients who have an INRG Stage L2 tumor without amplification of MYCN
• Patients with bone marrow failure syndromes
• Pregnancy and Breastfeeding
Conditions: Cancer
Keywords: high risk, metastatic, neuroblastoma
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AOST2032; A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin. Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Principal Investigator: Robin Williams
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001870
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 40 years old
• new diagnosis of osteosarcoma of any site
Exclusion Criteria:

• previous treatment for osteosarcoma
• brain metastasis
• history of high blood pressure (140/90) that has required medication
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Osteosarcoma
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Post-contracture release radiation for Dupuytren's disease

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Principal Investigator: Leslie Chang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00002191
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnoses of Dupuytren's disease
• English-speaking
Exclusion Criteria:

• people who have Dupuytren's disease and are not currently seeking treatment
Keywords: Dupuytren Contracture, Dupuytren's Disease
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MTT for H.S. Investigate whether restoring normal gut microbiome composition with cMTT influences the relative overabundance of anaerobic bacteria and microbial diversity of the skin in patients with HS

This research is being done to gain a better understanding of Hidradenitis Suppurativa (HS) and treatment with oral capsule microbiota transplant therapy (MTT) and the effects. Participants will be randomized (by chance) into 1 of 2 groups, treatment or placebo (no active ingredients) group. This study will last for up to 6 months

Principal Investigator: Noah Goldfarb
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018878
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of Hidradenitis Suppurativa (HS)
• able to speak English
• women who are of child bearing age must use a highly effective form of birth control
• must be on a stable dose of medications for at least 30 days before starting the study
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• planning on moving within 6 months from start of study
• history of anaphylactic food allergies
• women who are pregnant, breastfeeding or planning to get pregnant during the time of the study
• history of inflammatory bowel disease or extensive bowel surgery
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Hidradenitis Suppurativa, HS
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Magnetic Resonance Imaging of Osteonecrosis of the Femoral Head

The purpose of this research study is to investigate new magnetic resonance imaging (MRI) methods to better detect and monitor osteonecrosis of the femoral head (ONFH) before and after treatment. ONFH causes injury to the hip joint that can lead to osteoarthritis (the breaking/wearing down of cartilage & tissues within the joint) and the eventual need for a hip replacement. It can be difficult to detect ONFH early on using current medical imaging techniques, which is when treatments may be the most effective. Furthermore, available treatments are not always effective at preventing the progression (spread or growth) of ONFH. This research may benefit others with ONFH by providing more effective medical imaging tools to detect ONFH earlier and inform treatment decisions to increase the chance of stopping or delaying the progression of ONFH and preventing hip osteoarthritis.

Principal Investigator: Casey Johnson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016964
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Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed with Stage 1 or Stage 2 osteonecrosis of the femoral head (ONFH)
• intend to have core decompression surgery to treat the ONFH
Exclusion Criteria:

• excluded from having an MRI based on Center for Magnetic Resonance Research (CMRR) safety criteria
• existing implantation of metal device in affected hip
• any health conditions that would pose a challenge for you to participate
• unavailable to undergo follow up MRI 6 months after core decompression treatment
Conditions: Bone, Joint & Muscle
Keywords: aging, core decompression treatment, MRI, Osteonecrosis, early diagnosis, hip
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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 18-88 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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults aged 18-88
• 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
• Diagnosis or clinical suspicion of chronic obstructive pulmonary disease (COPD)
• Diagnosis or clinical suspicion of interstitial lung disease (ILD)
• Unmanaged reflux
• Unmanaged allergies/postnasal drip
• 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
• Current or recent drug/alcohol dependency or abuse (stopped or completed treatment less than 6 months)
• 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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BEETroot juice to reverse functional impairment in PAD: The BEET PAD Trial (BEET PAD)

The BEET PAD Trial is a multi-centered double-blind randomized clinical trial of beetroot juice vs. placebo in 210 people with PAD. We hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. Our primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. Our primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, we will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling), and gastrocnemius muscle health. We will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion (1). Inter-individual variability exists in the extent of metabolic conversion of nitrate to nitrite (1,2). Therefore, we will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively. To achieve our specific aims, we will randomize 210 participants age 50 and older with PAD to one of two groups: beetroot juice vs placebo. Participants will be followed for 4.5 months.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022643
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosis of peripheral artery disease (PAD)
• 50 years of age or older
Exclusion Criteria:

• Above- or below-knee amputation
• Critical limb ischemia symptoms of rest pain
• Wheelchair or walker is needed to walk
• Walking is limited by a symptom other than PAD
• Current foot ulcer on bottom of foot
• Planned major surgery, coronary or leg revascularization during the next five months
• Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
• Major medical illness including lung disease requiring oxygen, Parkinson’s disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years
• Allergy to beetroot juice
• Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study
• Currently eating one cup or more of beets daily
• Non-English speaking
• Participation in or completion of a clinical trial in the previous three months
• Visual impairment that limits walking ability
• Participation in a supervised treadmill exercise program in previous three months or planning to begin a supervised treadmill exercise program in the next five months
Conditions: Heart & Vascular
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A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)

Hidradenitis Suppurativa (HS) is a chronic condition that causes bumps or boils, often in the folds of armpits, chest, breasts, groin, stomach, back or sides, or buttocks. This Study is being done to compare the safety and effectiveness of a Study Drug called ruxolitinib cream with a vehicle cream for people with hidradenitis suppurative. A vehicle cream looks like the Study Cream but does not have active drug in it. Participants will be in the Study for approximately 60 weeks. This includes a 28-day screening period, 16 weeks of receiving either the Study Cream or vehicle cream, 36 weeks of receiving the Study Cream, and a 30-day follow-up.

Principal Investigator: Noah Goldfarb
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025137
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Hidradenitis Suppurativa (HS) at least 6 months before starting the study
• see link to clincialtrials.gov for complete inclusion criteria
Exclusion Criteria:

• people who have cancer
• women who are pregnant or breastfeeding
• see link to clincialtrials.gov for complete exclusion criteria
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Hidradenitis Suppurativa, HS1
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MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)

The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).

Principal Investigator: Patrick Nachman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019751
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
Exclusion Criteria:

• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
Conditions: Immune Diseases
Keywords: Clinics and Surgery Center (CSC), Lupus, Lupus Nephritis, SLE, Systemic Lupus Erythematosus
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Evaluation of an oral microbiota-based therapeutic as a treatment option for primary sclerosing cholangitis

We are studying the safety and feasibility of microbiota transplant therapy (MTT) for patients with Primary Sclerosing Cholangitis (PSC). The purpose of this study is to evaluate whether MTT from a healthy donor is safe and can be used to restore the healthy composition of microbiota to help decrease disease severity and improve symptoms. All patients in this study will receive capsules of the drug, MTT.

Principal Investigator: Elizabeth Aby
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020840
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 18-76
• serum total bilirubin ≤ 2x the upper limit of normal
• expect to maintain current medication regimen for the duration of the study
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received antibiotic therapy (except vancomycin) in the past 3 months
• complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome
• viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS
• liver disease such as metabolic or inherited disease or cirrhosis
• women who are pregnant, breast feeding, or trying to become pregnant -active cancer
• active alcohol overuse (>4 drinks per day for men, and >2 drinks per day for women)
Conditions: Digestive & Liver Health, Microbiota
Keywords: Clinics and Surgery Center (CSC), Primary Sclerosing Cholangitis, PSC
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Vosoritide in Infants and Young Children with Hypochondroplasia, Aged 0 to < 36 Months

The purpose of this study is to learn the effects, good or bad, of the study drug, vosoritide, for treating children who have hypochondroplasia. This condition affects the growth of bone and cartilage and in which kids who have it are shorter than other kids of the same age. In this study, your child will get either the study drug or placebo, which is an inactive medicine.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026654
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 0 months to less than 36 months old
• confirmed genetic diagnosis of Hypochondroplasia (HCH)
• participant's weight must be ≥ 3 kg (6.6 pounds)
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• short stature condition other than HCH
• have an unstable medical condition
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Diabetes & Endocrine, Rare Diseases
Keywords: HCH, Hypochondroplasia
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Assessment of Breast and Nipple Sensation Following Nerve Grafting in DIEP Flap Breast Reconstruction: A Prospective Study Using Two-Point Discrimination and Semmes-Weinstein Monofilaments

This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.

Principal Investigator: Umar Choudry
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025141
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18-90 years of age
• assigned gender of female at birth
• having a DIEP flap breast reconstruction with nerve grafting of one or both breasts
Exclusion Criteria:

• peripheral neuropathy or sensory deficits
• having an alternative reconstruction technique or a revision
Conditions: Cancer
Keywords: Breast cancer, DIEP breast reconstruction, reconstructive breast surgery
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AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001674
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
Exclusion Criteria:

• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
Conditions: Cancer
Keywords: lung cancer, osteosarcoma, pulmonary metastases, thoracotomy
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ANBL2131/MT2024-35- A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

This phase III trial tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022164
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: less than or equal to 30 years at the time of initial diagnosis with high-risk disease Diagnosis
• Must have a diagnosis of NBL or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
• Newly diagnosed, HRNBL defined as one of the following: a. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification b. Age:: greater than or equal to 547 days and INRG Stage M regardless of biologic features c. Any; age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy d. Age: greater than or equal to 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy BSA: Patients must have a BSA greater than or equal to 0.25 m2
Exclusion Criteria:

• Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.
• Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.
• Patients with known bone marrow failure syndromes.
• Patients on chronic immunosuppressive medications
• Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy.
• Female patients who are pregnant or breastfeeding their infant.
Conditions: Cancer
Keywords: neuroblastoma
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Left Sided Stellate Ganglion Blocks Impact on the rate of Post-operative Atrial Fibrillation in patients undergoing Thoracic Surgery: A pilot study

To determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care.

Principal Investigator: Jacob Hutchins
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021470
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• patients undergoing esophagectomy, pneumonectomy, or lobectomy
• aged 18-85
Exclusion Criteria:

• patients who have can't have regional anesthesia or stellate blockage
• women who are pregnant
Conditions: Breathing, Lung & Sleep Health
Keywords: esophagectomy, or lobectomy, pneumonectomy, stellate ganglion block
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The effects of cigarette smoking and alcohol on DNA damage in the oral cavity

The purpose of this study to examine the effects of cigarette smoking and drinking alcohol on the formation of DNA damage in the mouth. The overall goal is to identify DNA damage that may be important to the development of head and neck cancers.

Principal Investigator: Stephen Hecht, PhD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00021212
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Healthy individuals
• over 30 years old
• have 7 or more alcoholic drinks per week
Exclusion Criteria:

• Use tobacco/nicotine products
• Unstable health
Conditions: Prevention & Wellness, Cancer
Keywords: Alcohol, beer, liquor, ADH, drinking
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MT2023-29: Long-term Follow-up of Subjects With Sickle Cell Disease Treated With ExVivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector

The purpose of this study is to evaluate the long-term safety and ability of a transplant with gene modified stem cells (autologous stem cell transplant) to treat sickle cell disease. Participants must have received investigational gene therapy with bb1111 in a clinical study sponsored by bluebird bio. There is no additional treatment associated with this study as this is a long-term follow-up study.

Principal Investigator: Ashish Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020842
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to 53 years old
• treated with a clinical product to Sickle Cell Disease (SCD) in clinical study sponsored by bluebird bio-
Exclusion Criteria:

• there are no exclusion criteria for this study
Conditions: Rare Diseases, Blood Disorders
Keywords: SCD, Sickle Cell, Clinics and Surgery Center (CSC)
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A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

We are comparing treatment of early stage, hormone positive breast cancer with and without radiation therapy. One group will receive radiation therapy with endocrine therapy and the other group will receive endocrine therapy alone. We want to find out if there is any difference in how often breast cancer recurs in the same breast.

Principal Investigator: Jocelin Huang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC044
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• completed surgery to remove a breast tumor and there isn't any evidence of remaining tumor.
• Early stage (T1) tumor without lymph node involvement and a Oncotype DX Recurrence Score of less than or equal to 18
• ER and/or PgR positive and HER2 negative tumor
Exclusion Criteria:

• tumor size larger that T1
• surgical procedure was a mastectomy
• any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy given for the currently diagnosed breast cancer prior to study entry
• Women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Radiation, Stage 1 breast cancer. Hormone positive breast cancer
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ALTE22C1, Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.

Principal Investigator: Karim Sadak
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024697
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients age >= 6 and < 40 years at the time of enrollment.
• A diagnosis of Down Syndrome is required; all patients must be DS-AL survivors and have been treated for ALL or AML.
• All cancer treatment must have been completed at least 36 calendar months prior to enrollment.
Exclusion Criteria:

• Patients with history of Hematopoietic Stem Cell Transplant (HSCT) are excluded.
• Patients with a history of cancer prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded.
• Patients whose parents or guardians are unable to complete the required forms are excluded.
Conditions: Blood Disorders, Cancer
Keywords: ALL, AML, Clinics and Surgery Center (CSC), Down Syndrome, DS-AL survivors, leukemia
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Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma

To determine the prognostic factors for visual outcome for newly diagnosed NF1-OPGs. Hypothesis: Patients (<18 years of age) with tumors involving the optic tracts and/or radiations will demonstrate worse visual outcomes compared to those without optic tract involvement.

Principal Investigator: Clay Hoerig
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 1606M89501
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 18 years old
• EITHER the clinical diagnosis of NF1 OR have a constitutional NF1 mutation
• newly diagnosed Optic Pathway Glioma (OPG) (confirmed by MRI within 1 month of enrollment)
• additional inclusion and exclusion criteria (study staff will review)
Exclusion Criteria:

• OPGs involving only the optic radiations
• prior therapy for an OPG (e.g. surgery [including biopsy], radiotherapy, chemotherapy, etc.)
• prior therapy for another (non-OPG) tumor
• history of hydrocephalus requiring surgical intervention
Conditions: Cancer, Cancer
Keywords: OPG, Optic Pathway Glioma
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