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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.

409 Study Matches

Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease

A pilot study looking at an adult-based non-pharmacologic interventional trial in collaboration with psychologist who has expertise in cognitive behavioral therapy (CBT) for adolescents with chronic disease and intellectual disability and developing processes towards independence in non-Sickle Cell Disease settings.

Alexander Boucher
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018692
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Inclusion Criteria:

• 18 to 24 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
Exclusion Criteria:

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Blood Disorders, Mental Health & Addiction
SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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Ten Thousand Families Study

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

Jen Poynter
Not specified
This study is also accepting healthy volunteers
STUDY00000877
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Inclusion Criteria:

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

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Cancer, Microbiota, Prevention & Wellness
Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS
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MT2005-25 Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia

To determine the incidence of engraftment (defined as achieving donor derived neutrophil count >500/uL by day 42) in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.

Christen Ebens
Up to 3 years old
0511M77206
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Inclusion Criteria:
Matched sibling donor (HLA 8/8), if available, or a unrelated partially HLA matched single unit based on the following priority: 1st priority: 4/6 matched unit, cell dose >5 x 10-7 nucleated cells/kg 2nd priority: 5/6 matched unit, cell dose > 4 x 10-7 nucleated cells/kg 3rd priority: 6/6 matched unit, cell dose > 3 x 10-7 nucleated cells/kg Patients aged ≤ 3 years at diagnosis (not age of transplant) with hematological malignancy as detailed below: Acute myeloid leukemia: high risk CR1 as evidenced by: High risk cytogenetics t(4;11) or other MLL rearrangements; chromosome 5, 7, or 19 abnormalities; complex karyotype (>5 distinct changes); ≥ 2 cycles to obtain complete response (CR); CR2 or higher; Preceding myelodysplastic syndrome (MDS); All patients must be in CR or early relapse (i.e., <15% blasts in BM). Acute lymphocytic leukemia: high risk CR1 as evidenced by: High-risk cytogenetic: t(4;11) or other MLL rearrangements; hypodiploid; t(9;22); >1 cycle to obtain CR; CR2 or higher; All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology. Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: Patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy. MRD will be defined by either flow cytometry (>0.1% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (PCR or FISH) or conventional cytogenetics (g-banding). New Leukemia Subtypes: A major effort in the field of pediatric hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee. Recipients must have a Lansky score ≥ 50% and have acceptable organ function defined as: Renal: glomerial filtration rate > 60ml/min/1.73m^2 Hepatic: bilirubin, AST/ALT, ALP < 5 x upper limit of normal, Pulmonary function: oxygen saturation >92% Cardiac: left ventricular ejection fraction > 45%. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Exclusion Criteria:
Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days). History of HIV infection or known positive serology Myeloablative transplant within the last 6 months. Evidence of active extramedullary disease (including central nervous system leukemia).
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First Carpometacarpal Osteoarthritis Evaluation: Determining the Concurrent Validity and Test-Retest Reliability of the Thumb Disability Index (TDX) and Test-retest Reliability of Thumb Position Sense-Error using the Intermetacarpal Distance (IMD) Method

We are studying different questionnaires used to measure symptoms and activity limitations that are linked to thumb arthritis. We are also studying ways to measure thumb position sense in persons with thumb arthritis.

Corey McGee, PhD, MS, OTR/L, CHT
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006741
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Inclusion Criteria:

• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
Exclusion Criteria:

• received steroid injection treatment in the past 3 months
• history of CMC joint replacement
• nerve problems in the wrist or hand
• women who are pregnant
• unable to speak English
Arthritis & Rheumatic Diseases
Arthritis, CMC, CMC/Carpometacarpal, Osteoarthritis
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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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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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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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Intermittent Pneumatic Compression with and without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL (INTERCEDE)

The purpose of this study is to establish whether the device, intermittent pneumatic compression (IPC), both with and without walking exercise, can improve the ability to walk and prevent decline in the ability to walk for people with PAD. Intermittent pneumatic compression consists of blood pressure cuffs that are wrapped around the lower legs (below the knees) that inflate three times per minute. These cuffs may improve blood flow to the lower legs and feet.

Diane Treat-Jacobson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013094
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Inclusion Criteria:

• diagnosis of Peripheral Artery Disease (PAD) based on specific criteria that study staff will review
Exclusion Criteria:

• above or below-knee amputation
• wheelchair-bound
• currently have a foot ulcer on bottom of foot or ongoing infection of the toes, foot, or lower extremity
• walking is limited by a symptom other than PAD
• major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months
• already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months)
• non English speaking
• BMI greater than 45kg/M2
• major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness (study staff will review)
Heart & Vascular
peripheral arterial disease, cocoa, intercede, pad, peripheral artery disease, prove
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A novel partial-enteral nutrition protocol to improve nutrition status of adult patients experiencing a Crohn's disease flare and starting new immunologic therapy

The purpose of this study is to evaluate if a partial enteral nutrition diet, with a pea protein plant-based oral nutrition supplement (ONS; Kate Farms Peptide 1.5), combined with the Inflammatory bowel disease - Anti-Inflammatory Diet (IBD-AID) improves the nutritional intake of adult patients experiencing a CD flare initiating immunologic therapy compared to standard of care. Standard of care for patients experiencing a CD flare is commonly characterized by prescription of a low fiber diet and either lack of oral nutrition supplementation or use of an animal protein based supplement.

Byron Vaughn
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013936
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Inclusion Criteria:

• 18 years and older
• diagnosis of moderate to severe Crohn's Disease (CD) as defined by physician
• starting new advanced therapy
Exclusion Criteria:

• short bowel syndrome
• ileostomy or colostomy
• use of pre or probiotic supplements within last 14 days
• active implanted medical devices (cardiac pacemaker, defibrillator)
• pregnancy
• other serious medical conditions (study staff will review)
Digestive & Liver Health
Crohn's Disease (CD)
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An Early Feasibility Study Assessing Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH) (ASPIRE PH)

The objective of this study is to evaluate the safety and feasibility of implantation of the Aria CV PH System in subjects with pulmonary hypertension (PH) and right heart dysfunction. In addition, the study will evaluate early signals of performance of the implanted system.

Thenappan Thenappan
18 years and over
STUDY00011174
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Common
Inclusion Criteria:
18 years of age or older. Mean pulmonary artery pressure (mPAP) > 25mmHg. Right heart dysfunction as evidence by at least one of the following: Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm RV Fractional area change < 35% RV systolic velocity < 11.5 cm/s RV free wall strain < 18% Lateral tricuspid annulus peak systolic velocity (S') < 9cm/s Pulmonary compliance (C) < 3.0 ml/mmHg Current assessment of WHO FC III or ambulatory IV Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT). Subject is deemed appropriate for Aria CV device by the Subject Care Team at the investigation site and approved by the Eligibility Review Committee (ERC). The subject has agreed to participate in the study by signing the study specific informed consent form. The subject agrees to abide by device related travel restrictions. Unique Inclusion Criteria for WHO Group I: Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg Pulmonary vascular resistance (PVR) > 3 Woods Units (WU) The subject remains symptomatic despite being on a stable drug regimen of PH specific medication(s) appropriate for their PH classification for at least 90 days prior to planned index procedure. Unique Inclusion Criteria for WHO Group II:
• Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP > 15 mmHg 12. PVR > 3 WU Unique Inclusion Criteria for WHO Group III:
• Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis.
• PCWP ≤ 15mmHg 12. PVR >4 WU Common
Exclusion Criteria:
Diagnosis of WHO Groups 4 or 5 PH. Recent clinical event(s) of any of the following: Myocardial infarction or stroke within 6 months prior to the index procedure; Sustained tachyarrhythmia (documented heart rate >110/min) within 2 months prior to the index procedure; Uncontrolled, chronic atrial fibrillation. Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator, may interfere with Aria CV PH System placement or function. Any of the following medical history or comorbidities: a. History of endocarditis; b. History of unprovoked Pulmonary Embolism; c. Current renal insufficiency as demonstrated by an eGFR < 30 mL/min/1.73 m2 or end stage renal disease requiring chronic dialysis; d. Current diagnosis of scleroderma associated with: i. Any history of GI bleeding or receiving iron infusions within 2 years prior to enrollment; ii. Significant skin involvement that could compromise daily activities or the ability to receive IV medications, or sclerodactyly that causes surface ulcerations, digital ulcerations, or ulcerating calcinosis lesions. e. History of receiving immunosuppressant therapy as follows: i. Excluded if receiving Mycophenolate mofetil within 30 days prior to enrollment, or Rituximab within 6 months prior to enrollment, or currently receiving Prednisone at a dose > 12 mg per day at time of enrollment; ii. Excluded if any immunosuppressant other than Mycophenolate mofetil, Rituximab or Prednisone, per above. e. Current pulmonary veno-occlusive disease (PVOD); f. Current pulmonary capillary hemangiomatosis (PCH); g. History of clinically significant patent foramen ovale (PFO) or other inter-atrial or inter-ventricular shunt; h. History of gastric antral vascular ectasia (GAVE), gastrointestinal or intracranial bleeding which, in the opinion of the investigator, will predispose subject to major bleeding events following Aria CV device placement and warfarin anticoagulation regimen; i. Active infection requiring antibiotic therapy within two (2) weeks of procedure; j. Blood dyscrasias that may, in the opinion of investigator(s), expose subject to unacceptable procedural risks such as severe or worsening leukopenia, anemia, thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or coagulopathy. Anatomy is not suitable for placement of Aria CV device. Right heart valve regurgitation as follows: Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation; Severe (Grade 4) tricuspid valve regurgitation. Hypersensitivity or contraindication to: Required medications (e.g., contrast agents, warfarin, heparin) which cannot be adequately managed; Materials in device including polyurethane, silicone, nickel, and titanium. Ineligible for or refuses blood transfusion. Pregnant, nursing or is planning to become pregnant in the next two years. Life expectancy of less than two years. Currently participating in or planning to participate in other investigational study that may interfere with the outcome of this study. For subject on supplemental oxygen therapy - Subject adheres to the treatment regimen that in the opinion of the physician does not increase subject's safety. Previous diagnosis of cardiac amyloidosis. Unique Exclusion Criteria for WHO Group I: N/A Unique Exclusion Criteria for WHO Group II: Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM). Untreated severe aortic or mitral stenosis Diagnosis of heart failure with reduced ejection fraction (HFrEF) Previous diagnosis of nonobstructive hypertrophic cardiomyopathy. Unique Exclusion Criteria for WHO Group III: N/A
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Antimicrobial Stewardship Community Awareness and Acceptance in Minnesota

This is a community-based study engaging diverse Minnesota adults aged >=18 years. The goal is to understand the public's acceptance and awareness of antimicrobial resistance and stewardship efforts and subsequently look at electronic educational methodology to increase antimicrobial stewardship public engagement.

Beth Thielen
18 years and over
This study is also accepting healthy volunteers
STUDY00019421
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Inclusion Criteria:
Adults >/= 18 years and able to understand written English
Exclusion Criteria:
None
Community Health, Infectious Diseases, Microbiota
Antibiotic resistance, public health
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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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A Phase 2, Open-Label, Basket Study of Atrasentan in&#13;&#10;Patients with Proteinuric Glomerular Diseases (AFFINITY)

The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome.

Michelle Rheault
Not specified
This study is NOT accepting healthy volunteers
STUDY00012146
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Inclusion Criteria:

• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• age 18-70 years for patients in the DKD cohort
• receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks
• there are different requirements for each diagnosis category & study staff will review these
Exclusion Criteria:

• current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy
• history of kidney transplantation or other organ transplantation
• except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months
• blood pressure above 150 mmHg systolic or 95 mmHg diastolic
• history of heart failure or a previous hospital admission for fluid overload.
• history of liver disease
• hemoglobin below 9 g/dL or blood transfusion for anemia within the past 3 months.
• cancer in the past 5 years (except nonmelanoma skin cancer and curatively treated cervical carcinoma in situ)
• women who are pregnant, breastfeeding, or intend become pregnant during the study
• recently received an investigational agent -clinically significant unstable or uncontrolled medical condition (study staff will review)
Kidney, Prostate & Urinary
Glomerular Disease, Alport Syndrome, IgAN, FSGS, Proteinuric Glomerular Diseases
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Impact of Inflammatory Bowel Disease and IBD-related Surgery on Female Fertility: A Prospective Registry

This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.

Eugenia Shmidt
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003958
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Inclusion Criteria:

• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
Exclusion Criteria:

• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Digestive & Liver Health, Women's Health
Fertility, IBD, Inflammatory Bowel Disease
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Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes.  Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
SITE00001867
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Inclusion Criteria:

• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC), fatty liver, gastrectomy, sleeve, sleeve gastrectomy, weight loss
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Mechanisms of a Dynamic Stability Approach

If you have been referred to occupational therapy for thumb carpometacarpal osteoarthritis and you are 18 years or older, you are eligible for this study. Arthritis is the leading cause of disability in the United States, with an estimated 25.6 million Americans affected by osteoarthritis (OA) of the hand. Thumb carpometacarpal osteoarthritis (thumb carpometacarpal (CMC) joint osteoarthritis) is the most common and limiting form of hand osteoarthritis, causing chronic pain, weakness, reduced joint movement, and difficulty carrying out common daily tasks. The purpose of this research study is to find out if an 8-week dynamic stability program can help people with a range of CMC OA severity and symptoms. Dynamic stability (DS) is a new occupational therapy program that uses a series of exercises to strengthen specific muscles around the thumb CMC joint. By strengthening these muscles, the DS approach aims to reduce joint pain, delay further damage, and improve function and participation in daily activities. If you enroll, we expect that you will be in this research study for 9 weeks, for a total of about 15 hours of participation. During the study, you will participate in: 4 occupational therapy (OT) study visits (about 60 minutes each), a home exercise program (15-20 minutes/day) for 8 weeks and, 2 assessment visits (Baseline, and week 9) where we will using Computerized Tomography, a type of X-ray, and ultrasound to take measures of your affected joint and have you complete questionnaires related to pain and disability.

Corey McGee, PhD, MS, OTR/L, CHT
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015249
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Inclusion Criteria:

• Thumb Carpometacarpal (CMC) Osteoarthritis confirmed by xray
• referred to occupational therapy for treatment of thumb CMC osteoarthritis
Exclusion Criteria:

• cortisone treatments to the affected thumb within the prior three months
• hand rehabilitation within the past six months
• thumb CMC joint replacement
• diagnosis of inflammatory arthritis
Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Arthritis, Hand Arthritis, Occupational Therapy, Carpometacarpal, Osteoarthritis, Thumb joint, Clinics and Surgery Center (CSC)
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Defining Clinical Endpoints in LGMD (GRASP-01-001)

The purpose of this study to learn more about Limb Girdle Muscular Dystrophy by measuring how muscles change over a twelve-month period. Our clinical evaluator will test muscle strength and participants will be asked to complete a series of questionnaires to find out how Limb Girdle impacts daily activities. This information will help plan future studies and drug development for people with LGMD.

Peter Kang
Not specified
This study is NOT accepting healthy volunteers
SITE00001632
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Inclusion Criteria:

• 4 to 65 years of age
• diagnosis of Muscular Dystrophy with weakness in either a limb-girdle pattern, or in a arm or leg
• confirmed mutation in ANO5, CAPN3, DYSF, DNAJB6 or SGCA-G.
Exclusion Criteria:

• bleeding disorder, platelet count less than 50,000, or currently taking an anticoagulant.
• women who are pregnant
• other illness that would interfere clinical trial (study staff will review)
Rare Diseases
Limb Girdle Muscular Dystrophy, Limb-Girdle Muscular Dystrophy (LGMD), Muscular Dystrophy
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Evaluate the perspectives of cancer survivor patients and caregivers on using an intrathecal drug delivery system as a continuum of pain management care using a qualitative study.

Targeted medication delivery near the spinal cord (intrathecal pump) may be offered for cancer pain treatment in carefully selected patients. Prior studies showed an improved functional status reduction in oral medications and their side effects. Cancer survivors receiving intrathecal pump treatment for pain are eligible to participate in the research and share their stories. After consenting, a interview (45 minutes by zoom) will be conducted before and after the treatment to improve our understanding of patient perceptions of pain treatment with an intrathecal pump.

Vasudha Goel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016356
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Inclusion Criteria:

• cancer survivors with pain for more than 3 months duration who may benefit from intrathecal pump treatment for pain
Exclusion Criteria:

• people who are not eligible for treatment with an intrathecal pump
Cancer
Cancer Pain, Cancer Survivor, Intrathecal drug delivery systems (IDDS), Palliative Care, Chronic Pai
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GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

Aasma Shaukat
18 years and over
This study is also accepting healthy volunteers
SITE00001813
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Inclusion Criteria:

• at least 18 years old
• able to tolerate giving a blood specimen of up to 60 cc
• willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• people who have untreated colon cancer OR have previously removed adenomas, OR have a family history of colon cancer OR have a current positive screening stool test in the past 12 months that hasn't been evaluated
• Healthy Controls: have no history of finding polyps, no family history, or negative colorectal cancer screening test (if performed) within past 12 months
Exclusion Criteria:

• people who have had surgery, radiation, or chemotherapy for their current colorectal cancer or any other cancer
• history or clinically active Inflammatory Bowel Disease
• HIV or chronic active viral hepatitis
• history of cancer in the past 3 years (except minor skin, cervical, or endometrial)
• active chemotherapy or radiation treatment for any purpose
Cancer, Digestive & Liver Health
Colon Cancer, Colon Cancer, Colon Cancer Screening, Colorectal Cancer
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Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone metastases from Multiple Myeloma

There is no consensus on the radiation dose required to relieve the pain from bone lesions from multiple myeloma. Usually, patients receive between 10 and 12 radiation treatments to achieve pain relief. But a shorter course of radiotherapy may be more effective. This study will evaluate whether pain relief can be achieved using only 1 or 2 radiation treatments, which will be delivered to a painful bone lesion. Your study doctor will decide whether you receive 1 or 2 treatments. The total amount of radiation you will receive will be the same whether it is done in one or two treatment sessions.

Stephanie Terezakis
18 years and over
This study is NOT accepting healthy volunteers
STUDY00010991
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Inclusion Criteria:

• diagnosis of multiple myeloma
• painful bone metastasis that has been confirmed by a xray
• may have had any number of prior chemotherapy/immunotherapy regimens
• at least able to walk and do all selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for additional requirements
Exclusion Criteria:

• received prior radiation therapy or prior palliative surgery to the bone lesion that is causing pain
• pathologic fracture or impending fracture at the area of the bone lesion causing pain
• women who are pregnant
• additional criteria apply (study staff will review)
Cancer
Bone Pain, Metastatic Malignant Neoplasm in the Bone, Multiple Myeloma, Plasma Cell Myeloma
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Neuroplasticity in REM Sleep Behavior Disorder

REM sleep behavior disorder may predict the eventual symptom development of Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy. This occurs over years to decades and the sleep disorder may hide other typical symptoms and result in a delay in diagnosis. We are studying the changes in the brain over two years. We will do high field MRI’s (7T) and other tests of neurological function of people who have REM sleep disorder and people who don’t have this disorder (matched for age and sex).

Colum MacKinnon
18 years and over
This study is also accepting healthy volunteers
STUDY00016232
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Inclusion Criteria:

• Diagnosis of isolated iRBD confirmed by sleep study
• Able to walk independently without the use of an assistive device (e.g., cane) for at least 50 meters.
• 21 to 75 years old
Exclusion Criteria:

• Diagnosis of Dementia
• History of musculoskeletal disorders that significant affect movement of lower or upper limbs
• Other significant neurological disorders
• Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.
• Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).
• Untreated sleep-disordered breathing
• Pregnant women
Brain & Nervous System
Idiopathic REM sleep Behavior Disorder, iRBD, Sleep Disorder
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Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The study entails 2 visits over a 3-month period. On enrollment, participants will be scheduled for the 2 visits, during which fasting blood samples will be collected.

Reena Kartha
18 years and over
This study is also accepting healthy volunteers
STUDY00013672
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Inclusion Criteria:

• ages 18 to 80
• healthy volunteers without any known diagnosis
Exclusion Criteria:

• hematological cancer or other uncontrolled medical conditions
Rare Diseases
Gaucher Disease, Healthy Volunteers
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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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Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord

The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.

Dinesh Deelchand
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00009397
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Inclusion Criteria:
We are looking for healthy children volunteers who are: Do not have a history of neurological disorder (stroke, brain, or C-spine injury, etc., and are 6 years of age or older at time of screening.
Exclusion Criteria:

• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
Brain & Nervous System
MRI, MRS
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COMPARE: Expanding first-line options for depression and matching treatments to patients: hatha yoga vs. behavioral therapy

We are studying treatment options for people who have depression. One group will practice hatha yoga and the other will have behavioral therapy. All treatments are done virtually via telehealth (computer) with no in person clinic visits.

Sabine Schmid
18 years and over
This study is NOT accepting healthy volunteers
SITE00001751
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Inclusion Criteria:

• Symptoms of depression
• Able to read English or Spanish
• Live in states of NC, MA, MN, or RI
Exclusion Criteria:

• Bone fracture or joint surgery in the past 6 months
• Unable to walk
• Severe heart failure or lung disease
• Engaged in yoga practice or psychotherapy more than once in the past 4 weeks
• Currently pregnant
• Active suicidal or manic symptoms
Mental Health & Addiction
alternative therapies, Depression, yoga
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Neural and Behavioral Markers of the Temporal Dynamics of Language Planning and Phonological Working Memory Processes in Persons Who Stutter

This is a study of persons who do and do not stutter between ages 7 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.

Jayanthi Sasisekaran
Not specified
This study is also accepting healthy volunteers
STUDY00013042
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Inclusion Criteria:

• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
Children's Health, Community Health
adults, attention, fluency, language, memory, speech production, Stuttering, children
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COG ARST2031: A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)

his phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. Cyclophosphamide is in a class of medications called alkylating agents. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Emily Greengard
Up to 50 years old
SITE00001780
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Inclusion Criteria:
Patients must be =< 50 years of age at the time of enrollment Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon stage, group, and age, as below. FOXO1 fusion status must be determined by week 4 (day 28) of therapy. RMS types included under embryonal RMS (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) Classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar RMS (ARMS) in the 2020 WHO Classification is the same as in the ICR and includes classic and solid variants ERMS Stage 4, group IV, >= 10 years of age ARMS Stage 4, group IV Patients will be eligible to remain on protocol therapy based upon stage, group, and age Bone marrow metastatic disease is based on morphologic evidence of RMS based on hematoxylin and eosin (H&E) stains. In the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (must be performed within 7 days prior to enrollment): Age; Maximum serum creatinine (mg/dL) 1 month to < 6 months; 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to < 1 year; 0.5 mg/dL (male); 0.5 mg/dL (female) 1 to < 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to < 6 years; 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to < 10 years; 1 mg/dL (male); 1 mg/dL (female) 10 to < 13 years; 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to < 16 years; 1.5 mg/dL (male); 1.4 mg/dL (female) >= 16 years; 1.7 mg/dL (male); 1.4 mg/dL (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment) If there is evidence of biliary obstruction by tumor, then total bilirubin must be < 3 x ULN for age All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
Patients with evidence of uncontrolled infection are not eligible RMS that is considered a second malignancy and previous cancer(s) that were treated with chemotherapy and/or radiation. Surgical resection alone of previous cancer(s) is allowed Patients with central nervous system involvement of RMS as defined below: Malignant cells detected in cerebrospinal fluid Intra-parenchymal brain metastasis separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed). Diffuse leptomeningeal disease Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS prior to enrollment. Note: the following exception: Patients requiring emergency radiation therapy for RMS. These patients are eligible, provided they are consented to ARST2031 prior to administration of radiation Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (e.g. autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy Vincristine and vinorelbine are sensitive substrates of CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
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Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF) (REHAB-HFpEF)

The purpose of this research study is to assess the effect of a physical rehabilitation program for people admitted to the hospital with a diagnosis of heart failure. After completing baseline tests, participants will be randomly assigned to one of two study groups. Randomization means that you are put into a group by chance. (It is like flipping a coin.) You will have an equal chance of being placed into either group. Participants are assigned to a rehabilitation intervention (treatment) group, or to the attention control group, that will receive usual care.

Tamas Alexy
18 years and over
This study is NOT accepting healthy volunteers
SITE00001824
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Inclusion Criteria:

• at least 60 years old
• in the hospital for at least 24 hours to treat acute heart failure
• heart failure episode included symptoms getting worse and the need to add or increase drugs to treat it
• able to walk 4 meters (13 feet) with or without a cane or walker when the study starts
• discharge to an independent living situation
Exclusion Criteria:

• acute heart attack in the past 3 months, or planned intervention in the next 6 months
• severe valve disease
• advanced kidney disease with dialysis planned in the next 6 months
• dementia
• already actively exercising at least 30 minutes at a time, twice a week for the past 6 weeks
Heart & Vascular
Clinics and Surgery Center (CSC), congestive heart failure, exercise program, Heart failure, rehabilitation
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Neural mechanisms of early visual dysfunction in psychosis

The purpose of this study is to look at symptoms, thoughts, and behaviors related to the way a person sees the world. This is called visual perception. This study will also look at brain function. We will study these things in people with and without psychosis. People with psychosis see the world differently than others. For example, they may experience hallucinations. We are interested in understanding how differences in the way people see the world relate to brain circuits. This project will use visual and behavioral experiments, EEG, and Magnetic Resonance Imaging (MRI) to look at how visual perception is different in people with and without psychosis. This research study has three visits lasting 2-4 hours each. We expect that these visits will take place over 2-3 months, depending on your availability and preferences.

Michael-Paul Schallmo
18 years and over
This study is also accepting healthy volunteers
STUDY00007958
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Inclusion Criteria:

• 18-60 years old
• normal or corrected-to-normal vision
• current diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:

• claustrophobia
• current substance dependence (other than nicotine)
• any vision problem (e.g. strabismus/crossed eyes, lazy eye, color blindness)
• current or past diagnosis of bipolar I disorder
Brain & Nervous System, Vision & Eyes
EEG, MRI, neuroscience, psychosis, vision
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teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) (teleABLE)

We are exploring ways to increase physical activity after stroke using a web-based rehabilitation program. The purpose of this study is to adapt the Activating Behavior for Lasting Engagement (ABLE) program using video visits so people with stroke can participate from home.

Emily Kringle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018044
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Inclusion Criteria:

• experienced a stroke in the last 12 months
• currently spend at least 6 hours per day sitting
• access to a device for virtual video visits
Brain & Nervous System, Heart & Vascular, Prevention & Wellness
dwell, exercise, occupational therapy, physical therapy, remote, stroke rehab, teleable, virtual
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