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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.

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EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature driven Analysis

We are studying the use of pembrolizumab to treat people who have stage IV non-squamous, non-small cell lung cancer. Pembrolizumab may help the body’s own immune system attack cancer so tumor cells cannot grow and spread. We are looking at when it is most effective to give the pembrolizumab and when to combine it with other anticancer drugs, pemetrexed and carboplatin.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC012
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Inclusion Criteria:

• confirmed stage IV non-squamous non-small cell lung cancer (NSCLC)
• PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells -
Exclusion Criteria:

• Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC
• EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations
• significant gastrointestinal disorders with diarrhea as a major symptom
• history of auto-immune condition (including Guillain-Barre Syndrome or Multiple Sclerosis) requiring ongoing or intermittent systemic treatment in the past 2 years
• pregnant or breast-feeding
Conditions: Cancer
Keywords: Lung Cancer, Lung Cancer, Immunotherapy, Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
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A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer

This study uses different drug combinations to treat women who have endometrial cancer that has come back or has not responded to treatment. The drugs have different ways of stopping the growth of tumor cells and we are looking to see if different combinations are more effective.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC011
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Inclusion Criteria:

• recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments
• following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell histology is excluded
• must have had one prior chemotherapeutic regimen for management of endometrial carcinoma
• Body weight > 30 kg
• able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption
Exclusion Criteria:

• Prior enrollment into a clinical trial including cediranib or olaparib; Note: prior bevacizumab is not an exclusion criterion
• Pregnant women are excluded
Conditions: Cancer
Keywords: Endometrial Cancer
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A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

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

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC003
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Inclusion Criteria:

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

• T4 tumors including inflammatory breast cancer
• clinical or radiologic evidence of metastatic disease
• previous history of invasive breast cancer or DCIS in the same breast
• Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Triple Negative Breast Cancer
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Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

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

Principal Investigator: Estephan Moana-Filho
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013924
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Inclusion Criteria:

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

• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only
Conditions: Bone, Joint & Muscle, Brain & Nervous System, Dentistry
Keywords: Functional Brain Imaging, Sensory Testing, Temporomandibular Disorders, Jaw Pain, TMJ
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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: Kathryn Dusenbery
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00002191
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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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Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)

The purpose of this study is to see whether providing pregnant women with probiotics during their pregnancy is associated with infant gut microbiome variation and improved neurodevelopmental outcomes. We expect that you and your child will be in this research study for approximately 8 months from the time you sign the consent from to the completion of your 6-month visit with your infant.

Principal Investigator: Marie Hickey
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016313
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Inclusion Criteria:

• pregnant women in their second or third trimester with a diagnosis of gestational diabetes
• screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) with screening done between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive a oral glucose tolerance test (OGTT)
• BMI 18.5-45 kg/m2 at first prenatal visit
• age 21-45 at time of delivery
• pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior)
• single pregnancy
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy or lactation
• inability to speak and understand English
• known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• history of type I Diabetes
• mothers currently taking over the counter probiotic preparation
Conditions: Women's Health
Keywords: women's health, pregnancy, pregnant women, gestational diabetes
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Natural History Study for DNA Repair Disorders

This research is being done to help us better understand the different DNA repair disorders. We will collect data and samples that we will use to develop new therapies and medicine to help treat the disease. We expect that participants will be in this research study for 3 years. Visits will occur every six months and alternate between in-person and remote. Remote visits should be expected to last 1-2 hours, and in-person visits should be expected to last 3-4 hours.

Principal Investigator: Peter Kang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015911
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Inclusion Criteria:

• at least 6 months old
• diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics
• have one or more of the neurodevelopmental or neurological complications such as gross motor delay, language delay, altered muscle tone (study staff will review)
• family member of an individual with the above condition
Exclusion Criteria:

• prior history of systemic gene or cell-based therapy
• participation in a clinical trial for treatment
Conditions: Rare Diseases
Keywords: Cockayne Syndrome, DNA Repair Disorder, Trichothiodystrophy, Xeroderma Pigmentosum, Clinics and Surgery Center (CSC)
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State Representation in Early Psychosis (STEP)

In the first phase of the study, participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews and questionnaires about their life experiences and mental health, and they will have an EEG and fMRI while completing computerized tasks. The second phase of the study is optional. In this phase, participants will test one of two forms of computerized cognitive training, or brain games. They will be asked to complete 10 hours of training over a 3-6 week period. After the training period is over, they will have two sets of follow up visits, one right after the training period and one five months later. At these appointments, participants will complete the same activities done in the first phase of this study, including the interviews, questionnaires, and imaging (fMRI and EEG) combined with computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

Principal Investigator: Sophia Vinogradov
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00009964
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Inclusion Criteria:

• able to speak and write English
• 15 to 40 years old
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis, with psychotic symptoms starting in the past 5 years
• no hospitalizations and on stable doses of medications for the past one month or more
• For healthy volunteers without a mental health diagnosis: will match on age, sex, etc. to people enrolled in the study.
Exclusion Criteria:

• currently pregnant
• history of neurological disorder
• previous head injury with loss of consciousness
• currently suicidal or has attempted suicide in the past 6 months
Conditions: Mental Health & Addiction
Keywords: Psychosis, Schizoaffective Disorder, Schizophrenia
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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.

Principal Investigator: Shanie Jayasinghe
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Brain & Nervous System, Community Health, Heart & Vascular
Keywords: stroke, chronic, independence, movement, hemiparesis, deficits, rehabilitation, neuroscience
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Wearable monitor for FOG detection

Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00011162
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Inclusion Criteria:

• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
Exclusion Criteria:

• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson’s disease, or a family member with a diagnosis of Parkinson’s disease.
Conditions: Brain & Nervous System
Keywords: Parkinson's
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Cortical Inhibitory Biomarkers of Acute Suicidal States in Adolescents

Risk for suicidal behavior in young people may include particular types of brain functions. The goal of this research is to learn more about the biology of the brain as it relates to suicidal thoughts and behaviors.

Principal Investigator: Charles Lewis
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00011433
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Inclusion Criteria:

• ages 13-21
• current diagnosis of depression
• prior history of either thoughts about suicide, or suicidal behaviors (a suicide attempt or a planned attempt that was stopped before it began)
• must be able to communicate verbally and in writing in English
• parental permission is needed for participants aged 17 or younger
• must have reliable internet connection
Healthy volunteers
also needed
Exclusion Criteria:

• Active substance use in the past month
• Neurological disorders such as seizures, head injury
Conditions: Children's Health, Mental Health & Addiction
Keywords: Depression, Suicide, Adolescent
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Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa

The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).

Principal Investigator: Carol Peterson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00010436
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Inclusion Criteria:

• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
Exclusion Criteria:

• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
Conditions: Mental Health & Addiction
Keywords: Bulimia Nervosa

Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients

Balance and walking problems in patients with Parkinson’s Disease do not respond well to the typical medication or surgical treatments. This research study uses five small wearable devices that attach to clothing and can measure the body’s location while performing walking tests, balance tests, and normal daily activities. By comparing patients with Parkinson’s Disease to people of similar age without Parkinson’s Disease, we hope to learn important differences relevant to the walking and balance problems in Parkinson’s Disease

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00007441
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Inclusion Criteria:

• Anyone who has been diagnosed with parkinsonism including Parkinsons disease, Normal Pressure Hydrocephalus, or atypical parkinsonism
• Healthy adults of similar age as study participants
Exclusion Criteria:

• people who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Conditions: Brain & Nervous System
Keywords: Deep Brain Stimulation (DBS), Falls, Parkinson's Disease
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Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)

The purpose of the study is to see how aerobic exercise and cognitive training alone or together affect cognition, brain structure and function, and physical fitness over the course of 18 months.

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

• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
Conditions: Brain & Nervous System, Community Health
Keywords: cognitive decline, memory complaint, mild cognitive impairment
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Prospective quantitative kinematic assessment of patients with normal pressure hydrocephalus

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

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

• People who have dementia of sufficient severity to impair their ability to make health-care decisions
• People who have other types of Parkinson's Disease
• People who are unable to stand without help
Conditions: Brain & Nervous System
Keywords: Normal pressure hydrocephalus, Hydrocephalus, Balance, Incontinence, Dementia
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Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)

The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.

Principal Investigator: Michael Mauer
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1205M14901
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Inclusion Criteria:

• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
Exclusion Criteria:

• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry
Conditions: Kidney, Prostate & Urinary, Rare Diseases
Keywords: Fabry disease, Kidney disease, Renal disease
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Minnesota Neurogenetics Repository

This research study is for participants who have an inherited neuromuscular disorder or neurogenetic disorder, or family members who are unaffected by such disorders

Principal Investigator: Peter Kang
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00011988
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Inclusion Criteria:
-individuals with muscular dystrophy, particularly those without genetic diagnoses and those with indeterminate genetic test findings
• individuals with DNA repair disorders including Cockayne syndrome, trichothiodystrophy, and xeroderma pigmentosum
• family members with a genetic neurological or muscle disease
Exclusion Criteria:

• none
Conditions: Rare Diseases, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Muscular Dystrophy
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DegenPRO: A multicenter prospective registry for the management of degenerative spine disorders

This registry will be used to gather specific information about patients diagnosed with a degenerative spine disorder. Patient registries are observational studies that focus on understanding how the treatments, tests, and services, that are used in routine clinical care and by specialists, affect patient health outcomes. A registry that is appropriately designed, conducted, and analyzed will provide unique scientific information about the effectiveness, safety, and quality of the health-care service or intervention that is being studied.

Principal Investigator: Christopher Martin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00000102
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Inclusion Criteria:

• diagnosed with a degenerative spine disorder and receiving treatment
Conditions: Bone, Joint & Muscle
Keywords: Clinics and Surgery Center (CSC), Degenerative Diseases, Spinal Cord
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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).

Principal Investigator: Bradley Clark
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Rare Diseases, Heart & Vascular
Keywords: CPVT, arrhythmia, ventricular tachycardia
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The (IRAD) International Registry for Acute Aortic Dissection (CCMOCPAAD)

The International Registry of Aortic Dissection (IRAD) was created in 1996 by cardiovascular specialists committed to expanding current knowledge of aortic dissection with the goal of improving patient outcomes. This registry study uses a standardized form to capture data from consecutive patients with aortic dissection at participating hospitals.

Principal Investigator: Stephen Huddleston
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1111M06641
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Inclusion Criteria:

• 18 to 80 years of age
• clinical diagnosis of acute aortic dissection
• Type A dissection
• Type B dissection
• Retrograde type B dissection
Exclusion Criteria:

• Aortic aneurysm
• Myocardial infarction
• Cerebral accident
• Active infection
Conditions: Heart & Vascular
Keywords: Aortic Dissection
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Neural Bases of Disgust Conditioning in Anorexia Nervosa

We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.

Principal Investigator: Lisa M Anderson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00009646
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Inclusion Criteria:

• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
Exclusion Criteria:

• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
Conditions: Mental Health & Addiction
Keywords: Anorexia, Eating Disorder, Mental Health
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Longitudinal Study of Porphyrias

The objective is to conduct a longitudinal investigation of the natural history, complications, and therapeutic outcomes in people with acute and cutaneous porphyria.

Principal Investigator: Marshall Mazepa, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000892
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Inclusion Criteria:

• patient of any age
• diagnosis of a porphyria
• biochemical findings, as documented by laboratory reports of porphyria-specific testing performed after 1980
Exclusion Criteria:

• elevations of porphyrins in urine, plasma or erythrocytes due to other diseases
Conditions: Rare Diseases
Keywords: Acute Porphyrias, Cutaneous Porphyrias
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Corrona Inflammatory Bowel Disease (IBD) Registry

This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.

Principal Investigator: Byron Vaughn
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007736
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Inclusion Criteria:

• at least 18 years old
• Diagnosis of one of the following by a gastroenterologist: Crohn's disease or Ulcerative colitis (UC)
• users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease
Exclusion Criteria:

• Participating in or planning to participate in a clinical trial studying new medications for Crohn's disease or Ulcerative colitis
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's disease, Ulcerative colitis
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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.

Principal Investigator: Craig Weinert
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 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)
Conditions: Brain & Nervous System, Respiratory System
Keywords: ICU, Intensive Care Unit, Pain, Ventilator
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Focus in NeuroDevelopment (FIND) Network: A Statewide Network for Research in Neurodevelopment

The purpose of this research project is to develop a registry and database of families with neurodevelopmental disorders.

Principal Investigator: Amy Esler
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: 1306M35301
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Inclusion Criteria:

• All ages
• All individuals with disabilities and families within the neurodevelopmental disorder community
• Also looking for clinicians, educators, and professionals in the field
Conditions: Children's Health, Mental Health & Addiction
Keywords: autism, OCD, ADHD, tic disorders, neurodevelopment, community outreach
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Graded Motor Imagery for Women at Risk for Developing Type I CRPS following Distal Radius Fractures

Background: Distal radius fractures (DRF) account for nearly one-fifth of all fractures in older adults, and women experience them 5x as often as men. Most DRF occur with low impact injuries to the wrist with an outstretched hand, and are often managed via closed treatment and cast immobilization. Women sustaining a DRF are at risk for upper limb immobility, sensorimotor changes, edema and type I complex regional pain syndrome (CRPS). Since CRPS onset is likely influenced by alterations in the brain’s somatosensory region, a rehabilitation intervention, Graded Motor Imagery (GMI), aims to restore cortical representation, including sensory and motor function, of the affected limb. To date, there are no studies on the use of GMI in reducing risk of or preventing the onset of type I CRPS in women with DRF treated with cast immobilization. Due to a higher likelihood of women with this injury developing type I CRPS, it is important to early intervention is needed. Methods/Design: This article describes a six-week randomized comparative effectiveness trial, where the outcomes of a modified GMI program (mGMI) + standard of care (SOC) group (n=33) are compared to a SOC only control group (n=33). Immediately following cast immobilization, both groups participate in four 1-hour clinic-based sessions, and a home program for 10 minutes three times daily until cast removal. Blinded assessments occur within 1 week of cast immobilization (baseline), at three weeks post cast immbolization, cast removal, and at three months post cast removal. The primary outcomes are patient reported wrist/hand function and symptomology on the Patient Rated Wristand Hand Evaluation, McGill Pain Questionnaire, and Budapest CRPS Criteria. The secondary outcomes are grip strength, active range of motion as per goniometry, circumferential edema measurements, and joint position sense. Discussion: This study will investigate the early effects of mGMI + SOC hand therapy compared to SOC alone. We intend to investigate whether an intervention, specifically mGMI, used to treat preexisiting pain and motor dysfunction might also be used to mitigate these problems prior to their onset. If positive effects are observed, mGMI + SOC may be considered for incorporation into early rehabilitation program.

Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1701M03721
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Inclusion Criteria:

• age 55 and older
• received closed treatment of distal radius fractures
Exclusion Criteria:

• central nervous system disorders (e.g., Brain injury, Spinal Cord Injury, Parkinson's, Multiple Sclerosis)
• surgical fixation of fracture
• non english speaking
• multiple fractures to the same arm
• conditions of the opposite upper limb which would result in painful and markedly limited active hand, wrist and forearm motion
• cognitive disorders which make it difficult to follow testing commands and home program participation
• significant visual impairment
Conditions: Bone, Joint & Muscle
Keywords: Musculoskeletal Pain, Clinics and Surgery Center (CSC), Closed, Complex Regional Pain Syndromes, Distal Radius Fracture, Fractures
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Synergistic Enteral Regimen for Treatment of the Gangliosidoses (SYNER-G) (Syner-G)

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

Principal Investigator: Jeanine Jarnes
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 1311M46101
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Inclusion Criteria:

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

• severe kidney disease
• females who are pregnant or breast feeding
• females who are post puberty who are unwilling to use highly effective birth control
Conditions: Rare Diseases
Keywords: GM1 Gangliosidoses, GM2 Gangliosidoses, Sandhoff Disease, Tay-Sachs Disease
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A Natural History Study of the Gangliosidoses

This is a research study documenting the natural history of disease in patients with GM1 or GM2 gangliosidosis. The information collected will be a way to evaluate disease progression and create a disease stage and severity index. Our goal is to use the data collected to measure the effectiveness of any treatments that are developed in the future.

Principal Investigator: Jeanine Jarnes
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1007M85712
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Inclusion Criteria:

• documented gangliosidosis disease
• able to complete neuropsychological and neurobehavioral assessments
• Late-onset gangliosidosis subjects must be able to tolerate MRI of the head
Exclusion Criteria:

• none
Conditions: Rare Diseases
Keywords: GM1 Gangliosidosis, GM2 Gangliosidosis, Sandhoff Disease, Tay-Sachs Disease
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Development of objective measures for multisensory effects on hearing

Paired sound and electrical stimulation can alter how the brain encodes sounds and the perception of sounds, as shown in emerging evidence from animal studies. The aim of this study is to develop measures for paired stimulation that can be used reliably. These measures assess the following aspects of hearing: basic hearing sensitivity and cochlear health, perception of loudness and pitch, and perception of speech and music/complex sounds. This will lead to a greater understanding in the hearing science community about how multisensory stimulation can alter activity in the auditory system and sound perception, which may lead to new techniques for improving hearing disorders.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022175
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Inclusion Criteria:

• not users of hearing aids or implanted devices
• normal hearing or hearing-impaired, with or without tinnitus
Exclusion Criteria:

• users of hearing aids or implanted devices
Conditions: Ear, Nose & Throat
Keywords: auditory plasticity, Hearing loss, neuromodulation, tinnitus, transcutaneous electrical stimulation
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Project SHINE (Sleep Health INitiative for Equity): Culturally informing a sleep extension intervention for African American adults

The purpose of the study is to better understand the experiences of healthy lifestyle behaviors (i.e., sleep and physical activity), and receive feedback on a sleep intervention that aims to improve sleep among African American adults who do not get enough sleep. Sleep is vital to engaging in a healthy lifestyle, living longer, and feeling energized throughout the day. This research will compare a sleep intervention program (“Sleep Intervention Group”) to a healthy homes education program (“Control Group”) to see if there are changes in sleep and physical activity among those in the Sleep Intervention Group. We expect that participants will be in this research study for about 6 weeks.

Principal Investigator: Ivan Wu
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017901
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Inclusion Criteria:

• not meeting Physical Activity Guidelines
• age range: 21 to 65 years
• body mass index range: 25.0 to 40 kg/m2
• average self-reported habitual sleep duration of ≤6 hours
• self-identify as Black or African American
Exclusion Criteria:

• self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
• pregnant or less than 4 months postpartum
• infant living in household less than 1 year old
Conditions: Prevention & Wellness
Keywords: obesity, Physical Inactivity, Sedentary Behavior, Sleep. Insufficient sleep
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