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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.

406 Study Matches

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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Assessment of usability and satisfaction with a take-home device presenting sound and body stimulation for back pain

The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP) compared to a group of participants who are engaging in integrative health practices. The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. Findings from this usability pilot study could help refine the approach and the multi-modal device for a future intervention study in cLBP participants.

Hubert Lim
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021883
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Inclusion Criteria:

• must have chronic lower back pain, defined as back pain lasting 3 or more months,
• willing to travel to the University of Minnesota and commit to the study duration
Exclusion Criteria:

• cannot have any implanted stimulation devices
Bone, Joint & Muscle
Back Pain
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Visual Perception in Visual Snow Syndrome

This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.

Michael-Paul Schallmo
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014113
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Inclusion Criteria:
? Between 18 - 60 years old ? Good general physical health ? No history of other neurological disorders or problems ? Fluent in English
Vision & Eyes
Visual snow, visual snow syndrome
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A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)

The purpose of the study is to see if ianalumab, compared to placebo, is effective and safe for treating wAIHA. A placebo looks like the study drug, ianalumab, but does not contain any active ingredient. Ianalumab belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies are molecules that can recognize and stick to a specific protein expressed on the cell surface or released free in the body. Participants will receive study drug (ianalumab or placebo) through the vein every 4 weeks (4 doses in total) during the treatment period.

Marshall Mazepa, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018783
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Inclusion Criteria:

• people with documented primary or secondary wAIHA
• had an insufficient response to or relapsed after one or more treatments
• Hemoglobin concentration at screening between 5 g/dL and 10 g/dL and experiencing symptoms of anemia
• dose of supportive medication must be stable for at least 4 weeks
Exclusion Criteria:

• wAIHA due to disease involving bone marrow
• prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to starting the study
• active viral, bacterial or other infections that require systemic treatment at time of screening, or a history of recurrent clinically significant infection
• positive for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb)
• contact study staff for additional criteria
Blood Disorders
hemolytic anemia, wAIHA, warm autoimmune hemolytic anemia
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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.

Ashish Gupta
Not specified
This study is NOT accepting healthy volunteers
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
Cancer
Neuroblastoma
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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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See this study on ClinicalTrials.gov

Bias in the Counseling of Black Patients

The purpose of this project is to learn about the stereotypes and discriminatory treatment that Black patients encounter to develop communication skills training and tools for clinicians that reduces the likelihood that Black patients feel stereotyped and discriminated against. We will ask you to participate in a two-hour focus group, either in-person or virtually.

Ebiere Okah
This study is also accepting healthy volunteers
STUDY00021309
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Inclusion Criteria:

• English speaking
• age 25 and older
• Black or African American
• born in the US or arrived in the US at age 5 or earlier
• received care for high blood pressure in the last year
• live in the Twins Cities Area
Exclusion Criteria:

• diagnosis of Cognitive impairment, dementia, or schizophrenia
• unable to see or unable to hear (hearing aids and glasses are fine)
Heart & Vascular
bias, discrimination, hypertension, racism
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A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Britt Erickson
35 years to 50 years old
This study is NOT accepting healthy volunteers
SITE00001183
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Inclusion Criteria:

• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
Exclusion Criteria:

• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), BRCA1, Ovarian Cancer
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See this study on ClinicalTrials.gov

Development of Tobacco Related Biomarkers

To maintain a biorepository (sample bank) of biological samples from different tobacco users and non-users to investigate how tobacco and nicotine products affect our bodies. The samples will be used by researchers to develop methods to look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. The goal is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases.

Stephen Hecht, PhD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021394
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Inclusion Criteria:
This study is recruiting people who fit one of the following:
• formerly smoked cigarettes daily
• uses smokeless tobacco
• smokes cigars
• uses nicotine gum, lozenges, patches, nasal spray, pouches, or inhaler
Exclusion Criteria:

• younger than 21 years old
• smokes or vapes marijuana
Community Health, Prevention & Wellness
chewing, cigarettes, cigars, nicotine, smokeless tobacco, smoking, tobacco, vaping, gum, patches
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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.

Lauren Fontana
18 years and over
This study is NOT accepting healthy volunteers
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-Barre syndrome, anaphylaxis, or angioedema)
• have received the influenza vaccine for the current season
Infectious Diseases
Clinics and Surgery Center (CSC), influenza, influenza vaccine, Solid organ transplant
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See this study on ClinicalTrials.gov

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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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.

Ryan Demmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009136
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Inclusion Criteria:

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

• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding
Diabetes & Endocrine
Prediabetes, elevated blood glucose, impaired glucose, blood sugar, obesity, Hemoglobin A1c, exercis
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Sex differences in the effecTs of brEaking uP sedentary behavior on vascUlar function in Type 2 Diabetes (STEP UP T2D)

Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Most studies that have examined the effects of changing sedentary behavior (SB) have focused on young healthy males and prioritized glycemic outcomes. We will look at the effect of 3 different ways of breaking up sitting: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, differences between men and women will be evaluated.

Mary Whipple
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018030
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Inclusion Criteria:

• 60 years or older
• postmenopausal (at least 12 months without a menstrual period)
• Type 2 diabetes (hemoglobin A1c 6.5% or more and/or previous diagnosis of type 2 diabetes)
• sedentary for at least 6 hours/day
• willing to abstain from food, caffeine, alcohol and exercise for at least 24 hours, and tobacco/smoking for at least 12 hours prior to each study visit
• able to speak and read English
Exclusion Criteria:

• Type 1 diabetes
• uncontrolled hypertension (resting systolic greater than 160 or diastolic greater than 110 mmHg)
• starting hormone therapy or changing in hormone therapy (dose/frequency/route of administration) in the previous 3 months
• on renal dialysis
• history of deep vein thrombosis (DVT)
• evidence of cognitive impairment
• physical impairment or disability that interferes with ability to engage in exercise (severe osteoarthritis, lower extremity amputation [other than toe(s)/partial foot], use of a walker or wheelchair, etc.)
• unstable medical/psychiatric condition that could impact study participation
Diabetes & Endocrine, Prevention & Wellness, Women's Health
physical activity, sedentary behavior, sitting
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See this study on ClinicalTrials.gov

Robotic Gait Training to Improve Functional Outcomes after SCI

We are researching the benefits of physical therapy guided exoskeleton gait training in people with a spinal cord injury. We want to describe the benefits to overall function and how the brain changes after gait training.

Leslie Morse
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018674
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Inclusion Criteria:

• spinal cord injury level C7-T12
• medically stable, no acute issues that would prevent gaiting
• motor complete (AIS A or B) spinal cord injury OR motor incomplete (AIS C or D) spinal cord injury who use a wheelchair for more than 50% of personal mobility
• height between 155-191cm (5'1" to 6'2")
• weight less than 113kg (248 pounds)
• sufficient upper body strength to complete sit-to-sit transfers
• women of childbearing age must agree to use contraception during study participation
Exclusion Criteria:

• women who are pregnant
• symptomatic orthostatic hypotension
• active Grade 2 or greater pressure ulcer that can be potentially worsened by use of an exoskeleton
• lower extremity contractures that interfere with wearing an exoskeleton
• unhealed lower extremity fracture
• history of neurologic diseases (e.g. stroke, peripheral neuropathy, myopathy)
• active treatment for epilepsy or thyroid disorders
• women with osteoporosis at baseline by DXA scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Spinal Cord Injury (SCI)
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Global Patient Registry of Inherited Retinal Diseases

The purpose of this research study is to collect timely and relevant data that will support the evolving research needs of the Inherited Retinal Disease community (IRD), in order to provide insights that can be used to improve patient management, and to inform development of future treatments. No visits, assessments, or procedures are mandated, and follow-up will be captured as part of your standard of care. The planned length of registry is of 8 years with a potential to extend the duration as needs evolve.

Sandra Montezuma
Not specified
SITE00001950
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Inclusion Criteria:

• at least 3 years old
• documented genetic diagnosis of X-linked retinitis pigmentosa (XLRP) or Achromatopsia (ACHM) with any signs or symptoms of disease
• Caregiver participants must be at least 18 years old and identified by the participant as the primary care giver
Exclusion Criteria:

• received a treatment in an Inherited Retinal Disease (IRD) related interventional trial, or is being screened for an IIRD-related interventional trial
• Caregiver participant has an IRD and has visual impairment
Children's Health, Vision & Eyes
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A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON? (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)

The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.

Joshua Hou
Not specified
This study is NOT accepting healthy volunteers
SITE00002014
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Inclusion Criteria:

• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
Exclusion Criteria:

• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)
Vision & Eyes
Cornea, Persistent Corneal Epithelial Defect, Vision Loss
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See this study on ClinicalTrials.gov

teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior using Telehealth (Main Trial)

We are exploring ways to promote healthy lifestyles during stroke rehabilitation using a web-based rehabilitation program. The purpose of this study is to compare two intervention approaches: teleABLE and Healthy Lifestyles Education. Both interventions are delivered using video visits, so participants can complete all study activities from home

Emily Kringle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021288
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Inclusion Criteria:

• at least 18 years old
• diagnosed with stroke more than 6 months ago
• report 6 or more hours of sedentary behavior on a typical day
• live in a community-based setting (i.e., personal residence, assisted living facility)
• mobile within the home, with or without an assistive device and without physical assistance
Exclusion Criteria:

• Stroke participants will be excluded if:
• currently receiving chemotherapy or radiation treatments for cancer
• have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinsons disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
• received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
• have a history of skin sensitivity related to adhesives
• pregnant or expecting to become pregnant in the next 2 months
• live in an institutional setting
• currently incarcerated
• stroke participants will also be excluded if they have severe aphasia
Brain & Nervous System
CVA, physical therapy, rehabilitation, remote, Stroke, virtual
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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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REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation (REACT-AF)

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

Lin Yee Chen
18 years and over
This study is NOT accepting healthy volunteers
SITE00002070
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Inclusion Criteria:

• history of symptomatic or asymptomatic paroxysmal or persistent atrial fibrillation (AF) and a moderate risk of stroke
Exclusion Criteria:

• documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA)
• reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
Heart & Vascular
AF, Clinics and Surgery Center (CSC), Stroke
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NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2

We are recruiting only healthy participants who do not have REM sleep behavior disorder. The information gained from this study will help the investigators understand more about REM sleep behavior disorder (RBD), and the possible underlying neurologic disorders that can cause RBD.

Michael Howell
18 years and over
This study is also accepting healthy volunteers
SITE00001442
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Inclusion Criteria:

• male
• 54 to 75 years old
• Caucasian
Exclusion Criteria:

• history of dream enactment
• diagnosis of Parkinson's Disease, dementia, MCI, or MSA
• blood relative with REM Sleep Behavior Disorder
Brain & Nervous System, Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), control, neurology, Parkinson's Disease, REM Sleep Behavior Disorder, sleep, RBD
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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.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
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
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
1608M93561
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Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:

• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
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Study of Nutraceutical Intervention with High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, type 1 (NF1)

This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).

Christopher Moertel, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014832
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Inclusion Criteria:

• clinical diagnosis of Neurofibromatosis type 1 and/or genetic testing
• measurable skin neurofibromas
Exclusion Criteria:

• treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation (study staff will review)
• swallowing difficulties or strong gag reflex that make it difficult to take study treatment
• supplement with high phenolic olive oil or curcumin within six months
• women who are pregnant or anticipate becoming pregnant
• history of other physical or mental health issues (study staff will review)
Rare Diseases
Dietary Supplement: curcumin, high phenolic extra virgin olive oil, Neurofibromatosis, Type 1 (NF1)
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MT2019-01: Adrenoleukodystrophy National Registry Study (ALD) and Biobank

The purpose of this research to enhance our understanding of adrenoleukodystrophy ALD and study biospecimens such assaliva, blood, urine and stool to identify potential biomarkers for early identification of dise. We invite people who have or are at risk to have ALD, including females who are known or at risk carriers of the mutation for ALD, to help us learn more.

Ashish Gupta
Not specified
This study is NOT accepting healthy volunteers
STUDY00003605
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Inclusion Criteria:

• age 0 to 100
• patient or family member diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation
• patient or family member with known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• living in the United States and territories
Exclusion Criteria:

• have undergone BMT or other cellular therapy
• not fluent in English who are unable to consent in-person
• people who are unable to read or write
Rare Diseases
Adrenoleukodystrophy, ALD, Cerebral Adrenoleukodystrophy
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A multicenter, single arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who have Hb >=10 g/dL in response to anti-C5 antibody and switch to iptacopan

The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to iptacopan.

Joan Beckman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018020
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Inclusion Criteria:

• diagnosis of Paroxysmal Nocturnal Hemoglobinuria PNH)
• hemoglobin level at least 10 g/dL
• on a stable regimen (dose and intervals) of anti-C5 antibody treatment (either eculizumab or ravulizumab) for at least 6 months
Exclusion Criteria:

• needed red blood cell transfusion in the past 6 months
• history of stem cell transplant or solid organ transplant
• Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody)
• history of cancer of any part of the body within the past 5 years
Rare Diseases
Clinics and Surgery Center (CSC), Paroxysmal Nocturnal Hemoglobinuria, PNH
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Kinematic signatures of postural instability and gait in Parkinson Disease

The purpose of this research is to better understand balance and walking in patients with Parkinson’s Disease. This research study uses small wearable devices that attach to clothing and can measure the body’s location while performing walking and balance tests.

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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ARACOG: A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated with Darolutamide or Enzalutamide (ARACOG)

To compare the effects of treatment with enzalutamide (ENZ) versus darolutamide (DARO) on the cognitive function of men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC) by comparing the change in the maximally changed cognitive domain from baseline in patients in each study arm by 24 weeks.

Stuart Bloom
18 years and over
This study is NOT accepting healthy volunteers
SITE00000986
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Inclusion Criteria:

• confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• castration-resistant prostate cancer defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL, while on treatment
• testosterone level of <50 ng/dL
• able to walk and care for self, but unable to work
• able to read & speak English
• able to swallow study tablets whole
Exclusion Criteria:

• prior chemotherapy for treatment of CRPC. Men who received chemotherapy for castrate-sensitive prostate cancer are eligible provided chemotherapy was completed more than 6 months ago
• prior treatment with specific drugs (study staff will review)
• radiation treatment for more than 21 days during enrollment in the study
• neurological diseases that affect thinking (dementia, seizures, etc.)
• chronic use of opiates that affects thinking
• significant history of falls or risk of falls
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Prostate Cancer, CRPC, Metastatic Prostate Cancer, Prostate Cancer, Prostate Cancer
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See this study on ClinicalTrials.gov

Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR (VAPOR 2)

The purpose of this study is to determine the safety and efficacy of the Vanquish System treatment in men who have intermediate risk prostate cancer. In this study, the Vanquish System will be used to destroy cancerous tissue in the prostate. After treatment, participants will undergo tests that will assess presence of prostate cancer.

Christopher Warlick, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019145
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Inclusion Criteria:

• 50 years or older
• PSA no more than 15 ng/ml
• cancer stage less than or equal to T2c
• had a multiparametric MRI within the last 12 months and MRI software guided fusion biopsy of the prostate within the last 6 months
Exclusion Criteria:

• prior surgery, intervention, or minimally invasive therapy, for the prostate cancer or bladder neck
• taking medications that have hormonal effects on the prostate or PSA or or testosterone supplement
• significant medical or mental health diagnosis (study staff will review)
Cancer, Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Prostate Cancer, Prostate Cancer
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See this study on ClinicalTrials.gov

A Phase 1 Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants At Risk of Acquiring Neonatal Herpes Simplex Virus Disease

The purpose of this study is to determine the dose of medication (Valacyclovir) needed to prevent an infant from developing herpes simplex virus (HSV) if the infant was potentially exposed to HSV at the time of delivery as they passed through the birth canal.

Mark Schleiss
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001830
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Inclusion Criteria:

• Mother has a history of genital HSV infection
• Mother is receiving oral acyclovir, valacyclovir, or famciclovir suppressive therapy for 7 or more days before delivery
• Gestational age 38 or more weeks at birth
• Infant is no more than 2 days of age at study enrollment
• Weight at study enrollment at least 2,000 grams
Exclusion Criteria:

• Evidence of neonatal HSV infection
• Evidence of sepsis
• Kidney anomalies or dysfunction
• Maternal genital lesions suspicious for HSV at the time of delivery
• Infants known to be born to women who are HIV positive (HIV testing is not required )
• Infant currently receiving acyclovir, ganciclovir, famciclovir, or any investigational drugs
Infectious Diseases, Children's Health
herpes simplex virus, neonatal herpes, HSV
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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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