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298 Study Matches

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

This is a double-blind randomized placebo-controlled clinical trial examining choline supplementation in 2-5 year old children with Fetal Alcohol Spectrum Disorders. Outcome measures are neurocognitive tests of memory, attention, and behavior.

Jeffrey Wozniak
All
2 Years to 5 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02735473
1506M74642
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Inclusion Criteria:

• Ages 2 years to 5 years of age
• Available parent or legal guardian capable of giving informed consent for participation.
• Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
• Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005).
Exclusion Criteria:

• Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
• Known history of a medical condition known to affect brain function.
• Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
• Known history of very low birthweight (<1500 grams)
Drug: Choline bitartrate, Drug: Placebo
Fetal Alcohol Spectrum Disorders
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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers (PRINCE)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601506
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population (PRINCE)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601493
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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Plasticity of motor systems in early stage Parkinson's disease

The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.

Colum MacKinnon
18 Years and over
NA
This study is also accepting healthy volunteers
NEUR-2019-28388
STUDY00008043
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Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years.
• Able to walk independently Inclusion Criteria For Control Subject Group:
• Age and sex matched to participants with PD.
• Able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder.
• Other significant neurological disorders that may affect participation or performance in the study.
• Implanted DBS or other neurosurgeries to treat PD.
• Pregnant women.
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group:
• Same as exclusion criteria of PD group
Brain & Nervous System
Parkinson
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UP0085: A POSTMARKETING, MULTICENTER, LONGITUDINAL, PROSPECTIVE, PHARMACOKINETIC, PHASE 1B STUDY IN PREGNANT WOMEN WITH CHRONIC INFLAMMATORY DISEASES TREATED WITH CIMZIA? (CERTOLIZUMAB PEGOL)

A postmarketing, multicenter, longitudinal, prospective, pharmacokinetic, phase 1B study in pregnant women with chronic inflammatory diseases treated with cimzia

Eugenia Shmidt
Phase IV
This study is NOT accepting healthy volunteers
NCT04163016
STUDY00009260
Digestive & Liver Health, Axial Spondyloarthritis, Crohn's Disease, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis
inflammatory bowel disease, Axial Spondyloarthritis (AxSpA), CZP, Certolizumab Pegol, Cimzia, Clinics and Surgery Center (CSC), Crohn's Disease (CD), Pharmacokinetics, Plaque Psoriasis (PSO), Pregnant Women, Psoriatic Arthritis (PsA), Rheumatoid Arthritis (RA)
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MT2019-47 Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) Protocol Number: 208467

This is a master protocol to investigate the safety and antitumor activity of T-cell receptor (TCR) engineered NY-ESO-1 Specific (c259) T Cells alone or in combination with other agents in HLA-A*02+ participants with NY-ESO-1 and/or LAGE-1a positive solid tumors. The protocol will initially include a substudy to investigate letestregene autoleucel (lete-cel, GSK3377794) treatment in previously untreated (1L) HLA-A*02+ participants with NYESO-1+ advanced (metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma (Substudy 1). A separate substudy will investigate letestregene autoleucel (lete-cel, GSK3377794) infusion as second line or higher (2L+) treatment in HLA-A*02+ participants with NY-ESO-1+ advanced metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma, who have progressed following treatment with anthracycline based chemotherapy for the purpose of registration (Substudy 2). The protocol may be amended at a later time to add additional substudies to investigate other NY-ESO-1 or LAGE-1a positive tumor types and other NY-ESO-1-Specific (c259) T Cells (potentially in combination with other agents).

Emily Greengard
Phase II
This study is NOT accepting healthy volunteers
NCT03967223
STUDY00009020
Neoplasms
Adoptive T-cell therapy, Advanced metastatic disease, Advanced unresectable disease, Clinics and Surgery Center (CSC), GSK3377794, Lete-cel, Letetresgene autoleucel, Leukapheresis, Myxoid/round cell liposarcoma, Positive solid tumors, Synovial sarcoma, T-cell receptors
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Emily Greengard
All
up to 25 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02402244
1603M85344
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Inclusion Criteria:

• Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
• Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
• Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
• All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)
• All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
• The following other benign/borderline conditions:
• Mesoblastic nephroma
• Teratomas (mature and immature types)
• Myeloproliferative diseases including transient myeloproliferative disease
• Langerhans cell histiocytosis
• Lymphoproliferative diseases
• Desmoid tumors
• Gonadal stromal cell tumors
• Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
• If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
Other: Cytology Specimen Collection Procedure, Other: Medical Chart Review
Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Lymphoproliferative Disorder, Malignant Solid Neoplasm, Myeloproliferative Neoplasm, Stromal Neoplasm
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Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries: A Multicenter Integrated Clinical Trial (Protocol # PRO16090503)

Combat and sports injuries as well as automobile accidents can result in complex knee injuries involving tears of two or more major ligaments. These are referred to as multiple ligament knee injuries (or knee dislocations). Other structures like nerves, blood vessels, tendons and bones may also be injured at the same time. Due to their severity, knee dislocations are difficult to treat and problems after surgery, such as poor healing, stiffness or looseness of the knee, persistent pain, and early arthritis, can be quite common. Experts agree that surgery is necessary after a knee dislocation, but they do not agree on when to perform surgery or when rehabilitation after surgery should be started. Early surgery for knee dislocations may result in better outcomes, but may also be associated with increased joint stiffness. However, delayed surgery may be associated with the knee being too loose. The best evidence for when to start rehabilitation is based on treatment of anterior cruciate ligament (ACL) injuries in sports, where early post-op rehabilitation is the standard. However, unlike ACL surgery which typically replaces the ACL with a tendon graft, surgeons frequently sew torn ligaments back together after a knee dislocation. Therefore, rehabilitation typically involves protection of the knee by keeping weight off the leg and only allowing the knee to move a little for 6 weeks, which delays return to activity. This study is being conducted to determine when the best time to do surgery is and when to start rehabilitation after surgery for the treatment of a multiple ligament knee injury.

Jeffrey Macalena
Not specified
Phase III
This study is NOT accepting healthy volunteers
NCT03543098
STUDY00002789
Bone, Joint & Muscle, Children's Health, Knee Dislocations, Multiple Ligament Knee Injuries
Clinics and Surgery Center (CSC), Knee Dislocation, Knee Injuries, Knee Injury, Knee Surgery, Knee injury, Multiple Ligament Knee Injury, Rehabilitation
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IMPact on Revascularization Outcomes of intraVascular ultrasound guided treatment of complex lesions and Economic impact (IMPROVE)

To compare the outcomes of patients with complex lesions treated with imaging guidance with IVUS versus angiography only.

Ganesh Raveendran
Phase IV
This study is NOT accepting healthy volunteers
NCT04221815
STUDY00014771
Atherosclerosis
Clinics and Surgery Center (CSC)
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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population (PRINCE)

A clinic-randomized study of behavioral economics-inspired "nudges" build into the the electronic health record system, with the goal of improving opioid prescribing decisions.

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04601480
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Inclusion Criteria:

• All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:

• Primary care providers who work less than 20% full time equivalent (FTE)
Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & Nudge
Opioid-use Disorder, Opioid Use, Opioid Abuse
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Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)

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

Michael Mauer
All
1 Year to 75 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01581424
1205M14901
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Inclusion Criteria:

• Patients diagnosed with Fabry disease who have/have not received enzyme replacement therapy where a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies or where patients have previously completed clinical trials which included measures of renal function and renal biopsies.
Exclusion Criteria:

• Patients with serum creatinine more than 2.5 mg/dL or known to have a renal disease other than Fabry.
Fabry Disease
Fabry disease, kidney function, kidney structure morphometry, Fabry kidney disease, Podocytes
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RANDOMIZED, DOUBLE-BLINDED PHASE III STUDY OF CABOZANTINIB VERSUS PLACEBO IN PATIENTS WITH ADVANCED NEUROENDOCRINE TUMORS AFTER PROGRESSION ON PRIOR THERAPY (CABINET)

Nicole Hartung
Phase III
This study is NOT accepting healthy volunteers
NCT03375320
Atypical Carcinoid Tumor, Carcinoid Tumor, Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm, Locally Advanced Pancreatic Neuroendocrine Tumor, Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm, Low Grade Lung Neuroendocrine Neoplasm, Lung Atypical Carcinoid Tumor, Lung Carcinoid Tumor, Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Pancreatic Neuroendocrine Tumor, Metastatic Thymic Neuroendocrine Neoplasm, Neuroendocrine Neoplasm, Non-Functioning Pancreatic Neuroendocrine Tumor, Pancreatic Serotonin-Producing Neuroendocrine Tumor, Stage IIIA Digestive System Neuroendocrine Tumor AJCC v7, Stage IIIB Digestive System Neuroendocrine Tumor AJCC v7, Stage IV Digestive System Neuroendocrine Tumor AJCC v7
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Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting

A multi-center, prospective, randomized controlled study employing an adaptive design study for interim sample size re-estimation. Objectives: -Demonstrate that PCI guided by iFR Co-registration is associated with superior clinical outcomes compared to PCI guided by angiography alone -To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI strategy -To establish the relationship between physiological guidance and improvement in associated angina and quality of life scores -To examine the outcomes in patients in whom an optimized post-PCI iFR can versus cannot be achieved

Greg Helmer
NA
This study is NOT accepting healthy volunteers
NCT04451044
STUDY00013653
Coronary Artery Disease, Ischemic Heart Disease
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MT2011-11C: High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Rescue for Neuroblastoma

This therapy involves the use of consolidation chemotherapy, autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available, patients should also consider post-transplant therapy with cytokines and monoclonal antibody (ch14.18) on a COG or NANT trial. Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #6. (It is strongly recommended to begin consolidation within 4-6 weeks after starting Induction Cycle #6).

Ashish Gupta
All
up to 30 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01526603
1112M07741
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Inclusion Criteria:

• Less than 30 years of age at diagnosis of neuroblastoma
• No evidence of disease progression: defined as increase in tumor size of >25% or new lesions
• Recovery from last induction course of chemotherapy (absolute neutrophil count > 500 and platelet > 20,000)
• No uncontrolled infection
• Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10^6 CD34 cells/kg for transplant are mandatory and 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)
• Adequate organ function defined as:
• Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (GFR) > 60 mL/min/1.73m^2 If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2 Exclusion Criteria
• Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful.
• Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.
Drug: Carboplatin, Biological: Autologous stem cell infusion, Biological: Granulocyte colony stimulating factor, Radiation: Radiation therapy, Drug: Isotretinoin (13-cis-retinoic acid), Drug: Melphalan, Drug: Etoposide
Neuroblastoma
peripheral blood stem cell transplantation, autologous stem cell transplant
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ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

We are doing this study to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for 2.5 to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Daniel Duprez
Phase III
This study is NOT accepting healthy volunteers
NCT05021835
STUDY00013843
Cardiovascular Risk, Chronic Kidney Disease, Inflammation
Clinics and Surgery Center (CSC)
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The (IRAD) International Registry for Acute Aortic Dissection

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

Andrew Shaffer
Clinical Outcomes Research
This study is NOT accepting healthy volunteers
NCT01552720
1111M06641
Aortic Dissection
aorta, dissection, feature
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Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit

This study explores the relationship between ultrasound measurements of muscle and adipose tissue and clinical, metabolic, and neurodevelopment outcomes in preterm infants.

Sara Ramel
All
2 Years to 4 Years old
Pilot
This study is NOT accepting healthy volunteers
NCT03479515
STUDY00008341
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Inclusion Criteria:

• toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
• written consent obtained from a parent before or at time of visit
Exclusion Criteria:

• toddlers who require medical support that prevents them from having ADP measurements taken
• those with an inability to sit in a supported seat for 5 minutes
• those weighing less than 10 kg
Device: Ultrasound
Prematurity
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A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naive-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD)

This research study is studying LUM-201 as a possible treatment for Growth Hormone Deficiency (GHD) in pre-pubertal (before puberty) children. Lumos Pharma is sponsoring this research study. Your child is being asked to be in this study because she or he has been diagnosed to have growth hormone deficiency; and your child’s study doctor thinks that your child might be a good candidate for this study. Growth hormone deficiency can result in growth failure. One of the most visible signs of growth failure is a height that is much shorter than most other children of the same age. This is called short stature. However, some children can have growth failure even if they do not have short stature. The standard treatment for growth hormone deficiency is daily injections under the skin of recombinant human growth hormone (rhGH). This study seeks to see if oral LUM-201 at various doses may achieve similar catch-up growth compared to rhGH and provide a safe and effective oral treatment alternative to daily injections. LUM-201 is to be taken by mouth and it is thought that it can increase the body’s ability to release growth hormone.

Brad Miller, MD, PhD
Phase II
This study is NOT accepting healthy volunteers
NCT04614337
STUDY00011599
Growth Hormone Deficiency
Catch-up growth, GHD, Growth hormone secretagogue, Height, LUM-201, Oral, PEM, PGHD, Predictive Enrichment Marker
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Statins In Intracerbral Hemorrhage

This is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation (restarting) of statin therapy (using the same agent and dose that they were using at ICH onset). Randomization will take into account: clinical site, statin dose and indication (primary vs. secondary prevention), current use or intent-to-use oral anticoagulants (OAC) and/or antiplatelets in the long-term post-ICH, and severity of ICH upon presentation as assessed by baseline ICH volume. Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or MACCE during the follow-up period.

Oladi Bentho
Phase III
This study is NOT accepting healthy volunteers
NCT03936361
STUDY00008834
Intracerebral Hemorrhage
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Long Term Outcomes and Quality of Life in Patients with Out of Hospital Cardiac Arrest

The purpose of this study is to assess the severity of illness and associated outcomes of neurological intact survival in patients treated with extracorporeal membrane oxygenation with central and peripheral cannulation techniques.

Demetri Yannopoulos
Clinical Outcomes Research
NCT00000000
STUDY00009218
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Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

All
11 Years to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04562688
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Inclusion Criteria:

• Potential participant is between the age of 11 and 18 (inclusive) at the time of consent.
• Potential participant has a clinical diagnosis of Autism Spectrum Disorder (ASD), as confirmed by medical/clinical records or standardized assessments/interviews (e.g., Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) or Autism Diagnostic Interview - Revised (ADI-R)).
• Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records.
• Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported.
• Potential participant has normal hearing (self/parent-reported).
• Potential participant is a fluent English speaker, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician, to ensure reasonable neuropsychological results on key assessments.
• Potential participant has adequate sensorimotor capacity to perform the intervention and study activities, including visual capacity adequate to read from a computer screen or mobile device at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician and/or study team.
• Potential participant must be clinically stable as a result of therapy or medication regimen for 4 weeks prior to enrolling into the study.
• Potential participant has reliable access to the internet.
Exclusion Criteria:

• Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years.
• Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team.
• Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team.
• Potential participant has medical illnesses/genetic syndromes deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment.
• Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
• Potential adult participant scores less than a 14 (75%) on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). Please note, this criteria applies only to adult participants, age 18, at the time of screening.
Other: CICADAS and then PEERS, Other: PEERS + CICADAS and then no-contact, Other: PEERS + Active Comparator and then no-contact
Autism Spectrum Disorder
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Bone as Regulator of Energy Balance and Male Fertility after SCI: A Pilot Study (Osteocalcin Protocol)

This study proposes a cross-sectional case-control pilot study. Spinal Cord Injury (SCI) is associated with altered bone metabolism, male infertility, and increased rates of insulin resistance. The researchers will perform testing for 30 men with SCI and 10 without SCI. Data will be used to power subsequent clinical trials. A Fairview letter of support has also been uploaded.

Leslie Morse
18 Years and over
Pilot
This study is also accepting healthy volunteers
PMR-2020-29213
STUDY00011054
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Inclusion Criteria:
SCI
Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study -Male age 18-50 -Have completed inpatient rehabilitation and are living in the community -Have motor complete SCI Use a wheelchair as primary mobility mode -English and non-English speakers No SCI
Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study -Male age 18-50 -Able to ambulate independently -English and non-English speakers
Exclusion Criteria:
SCI
Exclusion Criteria:
-presence of other neurological condition -use of chronic ventilator support -metabolic bone disease -thyroid disorder -current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year). -Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. No SCI
Exclusion Criteria:
-presence of neurological condition -metabolic bone disease -thyroid disorder -current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year). -known history of or found on baseline testing to have osteoporosis. -known history of or found on baseline testing to have diabetes. -known history of or found on baseline testing to have infertility. -Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Spinal Cord Injury
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Measurement of Upper Aerodigestive Tract Pressures During Phonation

The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works. High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders. If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.

Jesse Hoffmeister
18 Years and over
Pilot
This study is also accepting healthy volunteers
ENT-2022-30531
STUDY00015206
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Inclusion Criteria:
Patients with adductor laryngeal dystonia:
• Have experienced improvement in voice quality following injection of botulinum toxin into the thyroarytenoid complex
• Have received their most-recent injection within 6 months
• Age 18-80 years old
• Able to participate in informed consent
• Able to read and write in English Healthy Controls
• Age 18-80
• Have no known voice problem
• Have a VHI-10 score of 10 or below
• Able to participate in the informed consent process
• Able to read and write in English
Exclusion Criteria:
Patients with adductor laryngeal dystonia:
• Diagnosis of vocal tremor, abductor laryngeal dystonia, any type of vocal fold lesion, or vocal fold paralysis
• Known swallowing disorder (oropharyngeal or esophageal), with the exception of transient post-botulinum toxin injection-induced dysphagia
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or esophageal surgery
• Known nasal, pharyngeal, or esophageal obstruction Healthy Controls
• VHI-10 Score of 11 or above
• Report having a current voice or swallowing disorder
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or esophageal surgery
• Known nasal, pharyngeal, or esophageal obstruction
Ear, Nose & Throat
Clinics and Surgery Center (CSC)
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Neural mechanisms of early visual dysfunction in psychosis

This study was reviewed as a JIT under STUDY00006280. This submission will complete the initial IRB review process. We propose to study visual perception in PwP as a window into deviant neural processing. This allows us to use well-developed paradigms from animal models, and to translate directly from basic neuroscience to a clinical population.

Michael-Paul Schallmo
18 Years and over
NA
This study is also accepting healthy volunteers
PSYCH-2019-28336
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 (besides nicotine); Any vision anomaly (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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Early Intervention for Very Low Birth Weight Infants: Equity and Neurodevelopment (EVEN Study)

This study uses parental surveys and standard neurodevelopment testing to better understand the experience of families of very low birth weight infants with early intervention services in Minnesota. We are particularly interested in understanding how inequity, bias, and discrimination contribute to disparities in neurodevelopment outcomes for this population.

Anita Randolph
up to 18 Years old
NA
This study is NOT accepting healthy volunteers
PEDS-2021-30520
STUDY00014475
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Inclusion Criteria:
Birthweight < 1500 grams; Minnesota resident
Exclusion Criteria:
Cardiac defect; genetic abnormality
Brain & Nervous System, Children's Health
Prematurity, low birthweight, neurodevelopment
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Comparing Real-time fMRI Neurofeedback versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa

The goal of the purposed research is to extend our prior work (STUDY00003758: Real-time fMRI Neurofeedback to Alter Limbic Disturbances in Anorexia Nervosa) on real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) as an innovative neurocircuitry-targeted intervention for anorexia nervosa (AN). This project will include randomization to rt-fMRI or a sham controlled group to answer the following important unresolved question: Does a patient-led procedure aimed at altering brain activity impact limbic circuit function and key eating disorder and psychiatric symptoms in AN above the effect of a matched, but non-targeted sham condition? There is an urgent need to develop novel interventions that can directly alter the key neurobiological mechanisms that promote AN. Individuals with AN will be randomly assigned to participate in rt-fMRI neurofeedback targeting down-regulation of either the amygdala or a sham condition in which they receive feedback non-contingently tied to their activation patterns (e.g., activation patterns from a prior participant) during exposure to aversive images.

Ann Haynos
PSYCH-2019-28137
STUDY00008137
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A person-centered employment preparation program for adolescents and young adults with autism spectrum disorder and their families

This study includes the development and evaluation of a person-centered employment preparation program for families of transition-aged youth with autism.

Rebekah Hudock
NA
PEDS-2021-30175
STUDY00013507
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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.

Christine Conelea
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04578912
STUDY00010519
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Inclusion Criteria:
-- 12-21 years old -- right-handed -- able to undergo MRI -- currently experiencing chronic motor and/or vocal tics
Exclusion Criteria:
-- currently receiving therapy focused on tics -- currently taking neuroleptic/antipsychotic medications
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Continuous Theta Burst Stimulation (cTBS)
Brain & Nervous System, Children's Health, Mental Health & Addiction, Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence
CBIT, TMS, Tourette's, neurodevelopmental disorders, tics, transcranial magnetic stimulation
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See this study on ClinicalTrials.gov

Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Ida-Arlaine Fonkoue
18 Years and over
NA
This study is also accepting healthy volunteers
PMR-2021-30243
STUDY00014457
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Inclusion Criteria:
In addition to age and sex, other key inclusionary criteria are pre-menopausal and must have experienced a past trauma with or without PTSD Diagnosis.
Exclusion Criteria:
In addition to age and sex criteria, other exclusionary criteria are pregnant or breastfeeding; severe traumatic brain injury, hypertension, diabetes, heart disease, or vascular disease; illicit drugs within the past 6-months prior to participation; and inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3.
Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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BEGIN-OB-19: A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN)

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective CFTR modulators and their impact in children with CF on endocrine growth factors, the gut microbiome, respiratory microbiome, liver and pancreatic function, lung function, sweat chloride, and inflammatory markers.

Elissa Downs
NA
This study is NOT accepting healthy volunteers
NCT04509050
STUDY00010861
Cystic Fibrosis
CF, CFTR Modulator, Cystic Fibrosis, elexacaftor, ivacaftor, tezacaftor, triple combination therapy
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See this study on ClinicalTrials.gov