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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.

394 Study Matches

A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naive Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Amit Kulkarni
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007800
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Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Cancer, Respiratory System
Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer (ARASTEP)

ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. This study is being done to learn more about a new drug called darolutamide given in combination with ADT for prostate cancer.

Emmanuel Antonarakis
18 years and over
This study is NOT accepting healthy volunteers
SITE00001890
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Inclusion Criteria:

• diagnosis of adenocarcinoma of prostate
• treated with surgery and/or radiation therapy
• Serum testosterone 150 ng/dL or more
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Cancer
Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
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MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
SITE00002088
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Inclusion Criteria:

• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Metastatic Cancer, Solid Tumor Cancer
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A Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysema (ELEVAATE)

This study is for people who have emphysema (a disorder where too much air collects deep in the lungs) that is caused by the lack of a protein called alpha-1 antitrypsin (AAT) in the body. A deficiency of AAT (AATD) can damage lung and liver if not treated. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in subjects with AATD emphysema when compared with current approved AATD therapy with A1PI, known as Zemaira®.

Ronald Reilkoff
18 years and over
This study is NOT accepting healthy volunteers
SITE00001985
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Inclusion Criteria:

• age 18 to 80
• diagnosis of Alpha 1-Antitrypsin Deficiency (AATD)
• symptoms of emphysema related to AATD
• currently not smoking
Exclusion Criteria:

• diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
• on waiting list for lung or liver transplant
• active cancers or has a history of cancer within past 5 years
• significant congestive heart failure
• additional exclusion criteria (study staff will review)
Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), Alpha 1-Antitrypsin Deficiency, Emphysema
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A MULTI-CENTER STUDY OF NON-INVASIVE COLORECTAL CANCER EVALUATION IN CYSTIC FIBROSIS (NICE-CF) (NICE-CF)

We are comparing the results of stool sample testing to colonoscopy for people who have Cystic Fibrosis (CF). We want to find out how effective stool sample testing is in detecting adenomas, including colorectal cancer.

Shahnaz Sultan
18 years and over
This study is NOT accepting healthy volunteers
SITE00001560
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Inclusion Criteria:

• Ages 18 - 75 years of age without history of transplant, or adults with CF age 18 - 75 who have had a transplant
• Diagnosis of Cystic Fibrosis with a sweat chloride test result of at least 60 mmol/L and/or documented CF-causing CFTR mutations and clinical
• Speak and write English or Spanish
• Having a screening or surveillance colonoscopy for colorectal cancer (CRC)
Exclusion Criteria:

• Women who are pregnant
• Active inflammatory bowel disease (Crohns Disease or Ulcerative Colitis)
• History of colon cancer diagnosis and treatment within 5 years of enrollment
• Symptoms that indicate colonoscopy is for diagnostic purposes rather than as screening for CRC
Digestive & Liver Health, Rare Diseases
Clinics and Surgery Center (CSC), colon cancer screening, cystic fibrosis
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Addition of a pectoserratus block to interscalene block in patients undergoing total shoulder replacement.

This research is being done to determine if pectoserratus block with bupivacaine will provide improvement in pain control and decrease opioid use, relative to pectoserratus block with a saline solution, among patients undergoing total shoulder arthroplasty.

Jacob Hutchins
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019840
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Inclusion Criteria:

• 18 years to 85 years old
• having a total shoulder arthroplasty or reverse total shoulder arthroplasty
Exclusion Criteria:

• unable to receive regional anesthesia or nerve block
• Non-English speakers
• women who are pregnant
• currently using opioids and people who have chronic pain
Bone, Joint & Muscle
Clinics and Surgery Center (CSC), Shoulder Replacement, Total Shoulder Arthroplasty
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NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001733
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Inclusion Criteria:

• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
Exclusion Criteria:

• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Cancer, Women's Health
endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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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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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)

Michelle Rheault
Not specified
This study is NOT accepting healthy volunteers
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)
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Alport Syndrome, Focal Segmental Glomerulosclerosis
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Sleep Outcomes with DBS Therapy in Parkinson's Disease and Dystonia

The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.

Luke Johnson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018981
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Inclusion Criteria:

• at least 21 years old
• existing or planned 7T brain imaging
• surgery at UMN to implant DBS system planned as part of routine clinical care (or has already occurred, as long as the first programming session is at least 2 weeks away)
Exclusion Criteria:

• other significant neurological disorder
• history of dementia
• complications after surgery
• women who are pregnant
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Parkinson's Disease, Sleep Apnea
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison.

Melena Bellin
18 years and over
This study is NOT accepting healthy volunteers
SITE00001256
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Inclusion Criteria:

• diagnosis of acute pancreatitis no more than 90 days ago
Exclusion Criteria:

• definite diagnosis of chronic pancreatitis based on results of scans (study staff will review)
• pancreas tumors
• prior surgery on the pancreas
• pregnancy
• other significant health problems, study staff will review
Diabetes & Endocrine, Digestive & Liver Health
Diabetes, Pancreatitis, Pancreas
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Asymmetries in motor control and their impact on functional independence

We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.

Shanie Jayasinghe
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015809
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Inclusion Criteria:

• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
Exclusion Criteria:

• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Brain & Nervous System, Community Health, Heart & Vascular
stroke, chronic, independence, movement, hemiparesis, deficits, rehabilitation, neuroscience
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Cleansing device for the treatment of scalp and hair conditions

The objective of this study is to evaluate an improvement of scalp health after the use of an investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.

Ronda Farah
18 years and over
This study is also accepting healthy volunteers
STUDY00012927
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Inclusion Criteria:

• one of the following scalp conditions based on clinical opinion of a board-certified dermatologist: healthy scalp, dandruff, seborrheic dermatitis, or hair loss disease
• willing to defer pregnancy and use two contraceptive methods for the period of the study treatment
Exclusion Criteria:

• non-English speaking
• pregnant
• clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements
Dermatology (Skin, Hair & Nails)
Hair Loss, Scalp disease, Seborrheic Dermatitis, Dandruff
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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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Improving Diagnosis and Treatment in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

This is a multi-center, prospective, observational cohort registry study looking at kids and their relatives with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).

Bradley Clark
Not specified
This study is NOT accepting healthy volunteers
STUDY00011733
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Inclusion Criteria:

• anyone diagnosed with CPVT before 19 years of age.
Exclusion Criteria:

• significant medical history that isn't related to CPVT
Rare Diseases, Heart & Vascular
CPVT, arrhythmia, ventricular tachycardia
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Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation

This study is comparing the benefits and adverse effects of two delivery methods to help patients relax and decrease anxiety during his/her time on mechanical ventilation. This study is not examining the medication but rather the process of how the patient receives the sedation medication: patient controlled or usual care.

Craig Weinert
18 years and over
This study is NOT accepting healthy volunteers
1605M88241
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Inclusion Criteria:

• receiving mechanical ventilation (ventilator) in the Intensive Care Unit
• receiving medication for sedation or pain
Exclusion Criteria:

• prone (facing down) ventilation being used
• low blood pressure that is being treated with medication
• unstable medical condition (staff will review)
Brain & Nervous System, Respiratory System
ICU, Intensive Care Unit, Pain, Ventilator
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Electronic Platform for Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long‐Acting Growth Hormone Therapy (LAuGH TRACK UMN) (LAuGH TRACK)

The purpose of the study is to compare quality of life (QOL), adherence, insulin resistance, body composition and efficacy of LAGH to DGH in children with GHD.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00011784
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Inclusion Criteria:

• girls ages 2-11 years
• boys ages 2-13 years
• established diagnosis of pediatric growth hormone deficiency (GHD).
• For this study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of <10 ng/mL Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance.
Exclusion Criteria:

• any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment
• current treatment with long-acting growth hormone
• currently pregnant or breastfeeding
Children's Health, Diabetes & Endocrine
Growth Hormone Deficiency
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MT2021-24: A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Adult Patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie

The purpose of the study is to determine the safety and effectiveness of a new procedure to treat Mucopolysaccharidosis Type I Hurler-Scheie and Scheie (MPS I). This procedure involves collecting some white blood cells (termed “B cells”) and growing them outside of the body in a laboratory. While the cells are in the lab, the B cells will be changed to produce more of the IDUA that is missing. This process is called “genetic modification.” The newly modified B cells are then infused back into the participant.

Paul Orchard
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016974
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Inclusion Criteria:

• diagnosis of Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome
• creatinine clearance, calculated or measured directly, that is greater than 60ml/min/1.73m2
• ejection fraction at least 40% by echocardiogram
• must agree to stay <45-minute drive from the study site for a minimum of 5 days after cell infusion.
• must commit to traveling to the study site for the necessary follow-up evaluations.
Exclusion Criteria:

• known family inherited cancer syndrome
• had a previous hematopoietic stem cell transplant (HSCT)
• any medical condition likely to interfere with assessment of safety or efficacy of the study treatment (study staff will review)
Rare Diseases
Mucopolysaccharidosis IH/S, Mucopolysaccharidosis IS
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Neptunia A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care

Dermatomyositis (DM) and Polymyositis (PM) are both autoimmune diseases. In autoimmune diseases, the body’s immune system, which normally protects us against infection and illness, starts to attack the body’s own cells instead. The main purpose of this research study is to see whether an investigational drug called enpatoran (referred to as the “study drug”) works better than placebo to improve symptoms in people with DM or PM. A “placebo” looks like the study drug but does not have any active substance in it. Researchers also hope to find out more about how safe the study drug is and how well tolerated it is.

David Pearson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001761
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Inclusion Criteria:

• adults with primarily diagnosed with Dermatomyositis (DM) or Polymyositis (PM)
Exclusion Criteria:

• diagnosis of myositis within 3 years of cancer
• malignancy-associated or juvenile DM
Dermatology (Skin, Hair & Nails)
Dermatomyositis (DM), Polymyositis (PM)
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Investigating the Effects of VNS on Central Autonomic Network and Interoception

This study is being done to find out if vagus nerve stimulation (VNS) affects how different parts of the brain interact with each other and process information. Participants must be in the REVEAL study and have a new VNS device implanted for treatment of depression. The study will last for about 19 weeks after the VNS is implanted.

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021940
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Inclusion Criteria:

• enrolled in a health insurance plan that will cover the costs associated with standard health care services and injuries
• diagnosis of chronic (at least 2 years) or 4 or more recurrent depressive episodes
• VNS therapy recommended for treatment
• has not had an adequate response to four or more adequate antidepressant treatments
• enrolled in the REVEAL CSP or REVEAL AP3 research studies
Exclusion Criteria:

• had a prior implantable stimulation device
• currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• acutely suicidal or made a suicide attempt within the previous 6 months
• additional mental health diagnosis other than depression (study staff will review)
• not able or willing to use their dominant arm, or upper arm circumference is greater than 50 cm
• do not speak English
• women who are pregnant
Mental Health & Addiction
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Causal Modeling of Ecological Momentary Assessment and Wearable Data in Youth

Researchers want to find out more about how physical, cognitive, and emotional factors affect eating.

Amy Gross
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021073
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Inclusion Criteria:

• 13-17 years old
• BMI at least at the 95th percentile
• own a smartphone and are willing to wear a Garmin (we provide), download the Garmin Connect App on their smartphone and authorize Garmin to transfer study data study staff
Exclusion Criteria:

• medication changes in the last 28 days for medications that are likely to affect appetite, mood, and attention
Brain & Nervous System, Children's Health
adolescents, Eating behaviors
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Vasomotor symptoms of menopause and cardiovascular disease: What is the link?

Study to examine the physiological responses that occur during a hot flush in postmenopausal women

Manda Keller-Ross
18 years and over
This study is also accepting healthy volunteers
STUDY00013742
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Inclusion Criteria:
Participants must have completed menopause and experience either no menopausal hot flashes or experience three menopausal hot flashes a day.
Exclusion Criteria:

• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ? 35 kg/m2
Blood Disorders, Brain & Nervous System, Women's Health
autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

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.

Reena Kartha
18 years and over
This study is also accepting healthy volunteers
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
Rare Diseases
Gaucher Disease, Healthy Volunteers
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MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

This study is evaluating the efficacy of MultiStem (drug) on functional outcome in participants with ischemic stroke.

Muhammad Affan
18 years and over
This study is NOT accepting healthy volunteers
STUDY00008000
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Inclusion Criteria:

• clinical diagnosis of ischemic stroke involving cerebral cortex
• moderate to moderately severe stroke with a persistent neurologic deficit
Exclusion Criteria:

• stroke involving other areas of the brain
• stroke or head injury within the past 6 months
Brain & Nervous System
Ischemic Stroke, Stroke
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Autonomic regulation of blood pressure in premature and early menopausal women

The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.

Manda Keller-Ross
18 years and over
This study is also accepting healthy volunteers
STUDY00004979
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Inclusion Criteria:

• 35 to 70 years old
• experienced premature (less than 40 years old) or early (45 or younger) menopause OR
• premenopausal 35-49 years of age OR
• typical-age menopause who are between 50-70 years old
• menopause will be confirmed by report of amenorrhea for 12 months
Exclusion Criteria:

• nicotine or tobacco use within the past six months
• have diabetes or asthma
• diagnosed significant carotid stenosis
• additional medical diagnosis (study staff will review)
• women who are pregnant or breastfeeding
Heart & Vascular, Women's Health
Blood Pressure, Early Menopause, Hypertension, Menopause

A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECT (RECONNECT)

The purpose of this study is to investigate how effective and safe ZYN002, a transdermal gel, is in participants with FXS. The drug product ZYN002 is a pharmaceutically manufactured CBD. It is being developed as a clear gel that can be applied to the skin (called transdermal delivery), to provide consistent, controlled levels of CBD in the blood when it is given twice a day. Participants will be assigned by chance to get one of the following study treatments: Active study drug – ZYN002 or placebo. Assigning study drug by chance is called “randomization,” and it is an important part of testing an experimental study drug. Participants will be randomly assigned to study treatment according to a computer program and will have 1 in 2 chance of receiving the active study drug.

Amy Esler
3 years to 23 years old
This study is NOT accepting healthy volunteers
SITE00001338
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Inclusion Criteria:

• ages 3 to less than 23 years
• resides with caregiver who will continue to provide consistent care throughout the study
• diagnosis of Fragile X Syndrome (FXS) through molecular documentation
• body mass index between 12-30 kg/m2
• in generally good health based upon the results of medical history, physical exam, 12-lead ECG and clinical laboratory test results
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant, nursing or planning a pregnancy
• has transitioned to independent living or living in a residential facility such as a university setting or congregate care
• use of cannabis or any THC or CBD-containing product within 3 months first study visit or during the study
• positive drug screen, including ethanol, cocaine, THC, barbiturates, amphetamines (unless prescribed), benzodiazepines (except midazolam or comparable administered for blood draws and ECG collection), and opiates
• additional medical or mental health diagnosis (study staff will review)
Rare Diseases
Fragile X Syndrome
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PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00001347
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Inclusion Criteria:

• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
Cancer
recurrent cancer, refractory cancer, solid tumors
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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.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
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
Cancer
Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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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.

Alexander Boucher
18 years and over
This study is NOT accepting healthy volunteers
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
Blood Disorders, Mental Health & Addiction
SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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MT2023-10: A Phase 1 Study of FT522 in Combination with Rituximab in Participants with Relapsed/Refractory B-Cell Lymphoma

We are studying FT522 - a new product that is made by modifying cells in a laboratory - both with and without additional drugs, to see if it can help treat people with B-cell lymphoma. This study is for people who have had at least one treatment for their lymphoma, but the cancer either returned or did not respond to the treatment. We are testing this product to see what side effects it might have, as well as to see whether it is effective at treating B-cell lymphoma.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001976
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Inclusion Criteria:

• diagnosis of B-cell lymphoma (BCL)
• at least 1 prior systemic regimen of treatment
• men and women participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
Exclusion Criteria:

• women who are pregnant or breastfeeding
• capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
• body weight less than 50 kg (110 lb.)
• additional medical diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lymphoma, Relapsed/Refractory B-Cell Lymphoma
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