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404 Study Matches

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.

Sophia Vinogradov
Not specified
This study is also accepting healthy volunteers
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
Mental Health & Addiction
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.

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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Site for ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

We are continuing to study the SARS-CoV-2 coronavirus and the evolving new variants. We are looking at drugs that have Food and Drug Administration (FDA) approval for other uses. The goal is to determine if these drugs can make participants who get the coronavirus feel better faster and reduce death and hospitalizations.

Carolyn Bramante
18 years and over
This study is NOT accepting healthy volunteers
SITE00001271
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Inclusion Criteria:

• at least 30 years old
• confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days before starting study
• two or more current symptoms of acute infection for no more than 7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria:

• current or recent (within 10 days of starting study) hospitalization for COVID-19 infection
• current or planned participation in another interventional trial to treat COVID-19 (study physician will review)
• current or recent use (within the last 14 days) of study drug or study drug/device combination
COVID-19, Infectious Diseases
Primary Care, COVID, COVID-19

Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications

The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1. We will also examine if there is a change in these blood and brain chemicals after participants begin taking oral N-acetylcysteine (NAC), which is available both as a prescription medication and a natural product that has antioxidant and anti-inflammatory effects.

James Cloyd
18 years and over
This study is NOT accepting healthy volunteers
1506M74581
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Inclusion Criteria:

• 18 years or older
• diagnosis of Type 1 Gaucher's Disease (GD1) who are medically stable
• on a stable medication therapy for 2 years, or if dosage or drug has been changed it has been at least 6 months and condition is stable
Exclusion Criteria:

• women who are pregnant or breast feeding
• asthma that is currently being treated
• unable to have a MRI scan
Rare Diseases
Gaucher disease
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Brain Mechanisms of Qigong for Neuropathic Pain Relief in Adults with Spinal Cord Injury

The researchers aim to prove that Qigong practice can result in reduced or relieved neuropathic pain, improved mood, life satisfaction, self-efficacy, enjoyment to move, and community integration; and decreased fear of movement, use of medication or health care services for adults with spinal cord injury.

Ann Van de Winckel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011997
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Inclusion Criteria:

• 18 to 75 years old
• spinal cord injury (SCI) at least 3 months ago
• medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
• highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Exclusion Criteria:

• unable to have a MRI (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent the participant from following directions or from learning
• ventilator dependent
• pregnant or plans to become pregnant during study
• inability to perform kinesthetic imagery
Brain & Nervous System
SCI, Spinal Cord Injury
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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.

Colum MacKinnon
18 years and over
This study is also accepting healthy volunteers
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.
Brain & Nervous System
Parkinson's
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Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy (MARVEN Study)

The purpose of this study is to determine what clinical, electrocardiogram, and cardiac magnetic resonance imaging factors identify patients at risk for developing rapid irregular heartbeats requiring therapy by implantable defibrillator. We expect that participation will last for up to 4 years. The procedures will include wearing a heart monitor (Holter) for 24 hours, obtaining a blood sample for markers of heart disease, and having a cardiac magnetic resonance examination with contrast – a substance given intravenously to make the images better, prior to defibrillator implant. After the initial visit, participation will not require any additional visits since information about the clinical course will be acquired from medical records.

Chetan Shenoy
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007420
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Inclusion Criteria:

• At least 21 years of age
• Diagnosed with nonischemic dilated cardiomyopathy (NICM)
• On optimal medications for management
• If a cardiac defibrillator hasn't been implanted, must be willing to have a cardiac defibrillator implanted within 3 months of study enrollment
• If a cardiac defibrillator has been implanted, it must be more recent than July 1, 2018
Exclusion Criteria:

• Nonischemic cardiomyopathy due to other known causes such as amyloidosis, sarcoidosis, cardiotoxicity due to chemotherapy, hypertrophic cardiomyopathy,
• History of prior myocardial infarction, percutaneous coronary intervention, or coronary bypass grafting
• History of ablation to treat ventricular fibrillation
Heart & Vascular
Implantable cardioverter defibrillator (ICD), Nonischemic dilated cardiomyopathy (NICM), Clinics and Surgery Center (CSC)
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Cardiac Sarcoidosis Consortium

This is a registry study. The Cardiac Sarcoidosis Consortium (CSC) is an international, multicenter partnership among physicians and allied professionals at major medical centers with the unifying purpose to learn more about cardiac sarcoidosis through collaborative research.

Henri Roukoz
18 years and over
This study is NOT accepting healthy volunteers
1209M20465
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Inclusion Criteria:

• People who have been diagnosed with Cardiac sarcoidosis (CS)
• History of ventricular tachycardia or fibrillation
• Ventricular arrhythmias treated medically or with an implanted device
Heart & Vascular
Ventricular Tachycardia, Cardiac sarcoidosis, ablation, cardiac ablation, Clinics and Surgery Center (CSC)
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Quality of life in patients who have undergone different treatments for upper airway stenosis

The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.

Raluca Gray
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015986
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Inclusion Criteria:

• diagnosis of upper airway stenosis treated with tracheotomy or t-tube.
• seen at the Lions Voice Clinic
• at least 18 years old
• able to complete questionnaires in English without help
Exclusion Criteria:

• require mechanical ventilation
• neurological conditions such as stroke, cerebral palsy, neurodegenerative disease.
• new diagnosis (less than 1 year) of head and neck cancer as the indication for tracheotomy
Breathing, Lung & Sleep Health, Ear, Nose & Throat
Montgomery t-tube, airway stenosis, stenosis, t-tube, trach, tracheotomy, Clinics and Surgery Center (CSC)
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Cortical Inhibitory Biomarkers of Acute Suicidal States in Adolescents

Prospective study investigating brain activity associated with markers of suicidal behavior (SB) in adolescents.

Charles Lewis
Up to 18 years old
This study is also accepting healthy volunteers
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
Children's Health, Mental Health & Addiction
Depression, Suicide, Adolescent
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Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

Severe aortic valve stenosis can include stiffening and hardening of the heart valve leaflets (tissue that opens and closes in the heart valve) so that the valve cannot work properly. If left untreated, excessive strain put on the heart muscle will eventually cause it to fail or lead to other serious complications. This study is a research project to assess a way of replacing aortic valves without the need for open-heart surgery and without surgically opening the heart to remove the narrowed valve. The device under study is called the ACURATE Transfemoral Aortic Valve System. The study will compare the safety and effectiveness of the ACURATE Valve, along with other commercially available TAVR devices.

Marat Yanavitski
18 years and over
This study is NOT accepting healthy volunteers
SITE00000630
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Inclusion Criteria:

• severe symptomatic aortic stenosis
• able to return to the hospital for all required follow up visits
• additional requirements from cardiac evaluation/testing (study staff will review)
Exclusion Criteria:

• acute myocardial infarction within 30 days
• cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months
• significant medical or mental health issues including specific abnormal lab values (study staff will review)
Heart & Vascular
aortic stenosis, TAVR
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Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents

The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.

Karina Quevedo
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001202
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Inclusion Criteria:

• any gender identity
• 11-17 years old
• past suicide attempt and/or current suicide ideation
Exclusion Criteria:

• Autism Spectrum Disorder
• Cognitive Developmental Delay (IQ < 75 i.e.intellectual disability)
• diagnosis of Schizophrenia
Brain & Nervous System, Children's Health, Mental Health & Addiction
adolescents, mental health, self-harm, suicidal, suicide attempt, suicide ideation, teen brain train
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Vibrotactile stimulation of the larynx to treat unexplained chronic cough

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

Stephanie Misono
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012174
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Inclusion Criteria:

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

• current smoker or quit less than 3 months ago
• infectious cause for cough (e.g., TB, pertussis, COVID)
• history of known or suspected aspiration pneumonia
• recent intubation/neck surgery (within 8 weeks)
• neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA)
• untreated carotid artery disease
• electronic implants (e.g., pacemaker)
• specific medications (study staff will discuss)
• anticipate use of new medications to treat the cough during the period of the study
• currently having speech therapy for cough
• BMI > 40 (for transmission of VTS through soft tissue)
• allergy to adhesives
• drug/alcohol dependency or abuse
• pregnant
• without regular access to wifi and internet
Breathing, Lung & Sleep Health, Ear, Nose & Throat
chronic cough, cough, larynx, vibrotactile stimulation, Clinics and Surgery Center (CSC)
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Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial

To determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

James Flaherty
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009938
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Inclusion Criteria:

• undergoing one of the following elective or urgent (but not emergency) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
Exclusion Criteria:

• history of atrial fibrillation or flutter
• Infective endocarditis
• Left ventricular ejection fraction (LVEF) < 30%
• redo surgery
• unable to have a block because of local anesthetic allergy, bleeding problem
• Body mass index > 35kg/m2
• woman who is pregnant
Heart & Vascular
Clinics and Surgery Center (CSC), AF, Atrial Fibrillation, CABG, Cardiac Disease, Coronary Artery By-Pass Surgery
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Comparison of normothermia maintenance between resistive blanket and forced air warming systems in renal transplant surgery

The maintenance of normal body temperature is important for all patients undergoing anesthesia to maintain important body functions. To help patients maintain normal body temperature during the surgery, a warming device is used. This study will compare the effectiveness of a resistive blanket warming device to the standard of care forced air warming device.

Cole Bennett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012072
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Inclusion Criteria:

• having a kidney transplant (not an emergency surgery)
Exclusion Criteria:

• previous organ transplantation or nephrectomy
• diagnosis of end stage renal disease with decreased or no urine output
• previous upper extremity amputation
• sepsis or other infection
• women who are pregnant
Kidney, Prostate & Urinary
Kidney transplant
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See this study on ClinicalTrials.gov

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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APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

This study is being done to improve outcomes after kidney donation and kidney transplantation. We will test kidney donors and kidney transplant recipients for apolipoprotein L1 gene (called APOL1) variants (or forms of the gene) and to see how these may affect them. Genes control the traits inherited from your family such as your eye color or blood type. Only a blood sample (and possibly urine) will be collected. Information routinely collected as part of surgery will also be used in the study. There will not be any changes to usual medical care.

Rasha El-Rifai
Not specified
This study is NOT accepting healthy volunteers
SITE00000625
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Inclusion Criteria:

• living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African)
• people who have received a kidney transplant from an eligible living or deceased donor with recent African ancestry
• people who have received multi-organ transplants including a kidney plus an additional organ (i.e. liver, heart, lung, pancreas, etc.) or pediatric en bloc and dual kidney transplants
Kidney, Prostate & Urinary
Chronic, Kidney Disease, Kidney Diseases, Kidney Failure, Kidney Transplant
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Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

Melanie Nicol
18 years and over
This study is NOT accepting healthy volunteers
1610M98383
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Inclusion Criteria:

• at least 18 years old
• female, or transgender female with a cervix
• HIV- positive
• on a stable antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks before starting the study
Exclusion Criteria:

• currently pregnant, or previous pregnancy in the past 3 months, or breast feeding
• vaginal infection within 2 weeks before starting the study
• abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior starting the study
• use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to starting the study
Women's Health
HIV/AIDS, Inflammation Vagina, Menopause
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Biomechanical Mechanisms of Soft Tissue Deformation during the Volleyball Spike

No current studies have examined in vivo glenohumeral kinematics during the overhead volleyball spike despite the high prevalence of spike-related shoulder pain. The extreme shoulder positions achieved by volleyball players during the spike motion may contribute to unique deformations that could result in structural change or pathology of the rotator cuff and long head biceps tendons. The purpose of this study is to determine the extent to which GH kinematics differ between SAB and a simulated volleyball spike at a self-selected position of ball contact.

Paula Ludewig
18 years and over
This study is also accepting healthy volunteers
STUDY00015763
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Inclusion Criteria:

• 18 to 35 years old
• played at least 2 years of high school varsity-level volleyball and/or play competitive volleyball at the club level or NCAA D3/NAIA level or above
• have no shoulder pain that has resulted in removal from, or cessation of volleyball participation in the past 6 months
• have a negative clinical screening exam
• fluent in English
Exclusion Criteria:

• any injuries, impairments, or pain of the hitting arm that limits participation in volleyball
• shoulder pain related to the cervical spine
• history of trauma and/or surgery of the hitting shoulder
• currently pregnant.
Bone, Joint & Muscle
Volleyball, athlete, shoulder, spike mechanics
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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).

Carol Peterson
18 years and over
This study is also accepting healthy volunteers
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
Mental Health & Addiction
Bulimia Nervosa
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COCOA (COCOA-PAD II)

Among people with peripheral artery disease (PAD) age 55 and older, we will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. We will randomize 190 participants (32 in Minnesota) with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are six-month change in maximal treadmill walking distance, Actigraph-measured physical activity, whole body oxygen consumption, measures of nitric oxide (brachial artery flow-mediated dilation (FMD)), calf muscle endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, calf muscle perfusion (measured by magnetic resonance imaging (MRI)) and calf muscle characteristics (measured by calf muscle biopsy). To achieve our specific aims, we will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for seven months.

Diane Treat-Jacobson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001135
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Inclusion Criteria:

• Age 55 and older
• Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
Exclusion Criteria:

• Unable to tolerate study pills
• Inability to walk or requiring a walker
cocoa, intercede, pad, peripheral artery disease, prove
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Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients

This is a prospective study aimed at quantifying walking and balance in patients with parkinsonism in the clinical setting in addition to a living environment 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. Demonstrate that parkinsonism patient-specific kinematics can be used to detect postural instability in the clinic using wearable IMUs. 2. Demonstrate that individualized, home-based postural response curves can detect postural instability and prospectively predict fall risk in patients with parkinsonism.

Robert McGovern, MD
18 years and over
This study is also accepting healthy volunteers
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
Brain & Nervous System
Deep Brain Stimulation (DBS), Falls, Parkinson's Disease
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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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Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)

Dereck Salisbury
18 years and over
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
Brain & Nervous System, Community Health
cognitive decline, memory complaint, mild cognitive impairment
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PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE)

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

Diane Treat-Jacobson
18 years and over
This study is NOT accepting healthy volunteers
SITE00000513
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Inclusion Criteria:

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

• above or below knee amputation, critical limb ischemia, or wheelchair confinement
• walking is limited by a condition other than PAD
• heart attack or stroke in the past 3 months
• medical or mental health disease that will interfere with study participations (study staff will review)
• currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• unwilling/unable to use a smart phone and unwilling to attend weekly study sessions
• unable to speak English
Heart & Vascular
cocoa, intercede, pad, peripheral arterial disease, peripheral artery disease, prove
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A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury

Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.

Ann Van de Winckel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014710
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Inclusion Criteria:

• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
Exclusion Criteria:

• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Brain & Nervous System
movement, sensation, spinal cord injury, SCI
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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

Improving Spinal Cord Stimulation with ECAP

The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.

David Darrow
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013100
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Inclusion Criteria:

• medically stable as determined by the principal investigator
• scheduled to have external spinal cord stimulation
• English-speaking
Exclusion Criteria:

• scheduled for permanent implantation without an external trial
• have a pacemakers or other neurostimulators
• women who are pregnant
Bone, Joint & Muscle, Brain & Nervous System
Pain, Spinal Cord Stimulation
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Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries: A Multicenter Integrated Clinical Trial (Protocol # PRO16090503)

This study is being conducted to determine when is the best time to do surgery is and when to start rehabilitation after surgery for the treatment of a multiple ligament knee injury. The study will randomize (i.e. a coin toss) when you have surgery and when you begin rehabilitation (early or delayed surgery and early or delayed rehabilitation). The type of surgery is decided between you and your surgeon. Rehabilitation is tailored to the type of surgery you have. You will fill out some questionnaires and have your knee examined at your normal postsurgery appointments with your surgeon.

Jeffrey Macalena
Not specified
This study is NOT accepting healthy volunteers
SITE00000183
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Inclusion Criteria:

• Ages 16-55
• Has a multiple ligament knee injury (MLKI is defined as a complete grade III injury of two or more ligaments)
Exclusion Criteria:

• Prior knee ligament surgery of the involved knee
• Torn or avulsed patellar or quadriceps tendon
• Periarticular or long bone fracture that is anticipated to preclude weight-bearing after surgery
• Require use of an external fixator for greater than 10 days
• Planned staged surgical treatment
• Unable to weight bear on the contralateral uninjured leg
• Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care
• Surgical procedures that precludes early weight-bearing or range of motion
Bone, Joint & Muscle, Children's Health
Knee injury, Clinics and Surgery Center (CSC)
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STRIKE-PE: A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

The purpose of this study is to collect information on how patients with PE recover after treatment with the Indigo Aspiration System. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head. The device is commercially available globally. Participants will be in this research study for about one year. Participants will be asked to complete a screening and baseline visit, device procedure in-patient visit as part of routine treatment for their PE, one post-procedure visit in the hospital and two follow-up visits. The study team will collect information on tests and procedures done during these visits from their medical records. They will also be asked to complete a quality of life questionnaire.

Christopher Jones
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013412
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Inclusion Criteria:

• at least 18 years old
• diagnosis of acute PE within past 14 days or less
Exclusion Criteria:

• unable to take heparin
• Stage III/IV cancer or cancer which requires active chemotherapy
• women who are pregnant
• other exclusions apply, contact study staff for more information
Heart & Vascular, Respiratory System
PE, Pulmonary Embolism
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