
Search Results
Neptunia A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care
Dermatomyositis (DM) and Polymyositis (PM) are both autoimmune diseases. In autoimmune diseases, the body’s immune system, which normally protects us against infection and illness, starts to attack the body’s own cells instead. The main purpose of this research study is to see whether an investigational drug called enpatoran (referred to as the “study drug”) works better than placebo to improve symptoms in people with DM or PM. A “placebo” looks like the study drug but does not have any active substance in it. Researchers also hope to find out more about how safe the study drug is and how well tolerated it is.
• adults with primarily diagnosed with Dermatomyositis (DM) or Polymyositis (PM)
• diagnosis of myositis within 3 years of cancer
• malignancy-associated or juvenile DM
SPR001-205 A Phase 2 Study to Evaluate the Safety, Pharmacokinetics,;and Exploratory Pharmacodynamics of SPR001 (Tildacerfont) in Children: Aged 6 to 17 Years with Congenital Adrenal Hyperplasia
The goal of this study is to test the safety and effectiveness of tildacerfont in children with congenital adrenal hyperplasia (CAH). When a child is enrolled in the study, in addition to taking the study drug (tildacerfont), he or she will continue to take his or her standard glucocorticoid doses. A part of the study will be to test different doses of the study drug and to measure adrenal hormones at each visit. Children will be in the study for 18 weeks and will have to visit the study clinic 5 times.
• age 2 to 17 years
• childhood diagnosis of classic congenital adrenal hyperplasia (CAH) a genetic mutation in CYP21A2
• currently taking steroids to treat CAH and on a stable dose for 1 month or more
• clinically significant unstable medical or mental health condition (study staff will review)
• females who are pregnant or nursing
• unable to swallow medications
Asymmetries in motor control and their impact on functional independence
We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.
• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Wearable monitor for FOG detection
Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.
• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson’s disease, or a family member with a diagnosis of Parkinson’s disease.
Cortical Inhibitory Biomarkers of Acute Suicidal States in Adolescents
Risk for suicidal behavior in young people may include particular types of brain functions. The goal of this research is to learn more about the biology of the brain as it relates to suicidal thoughts and behaviors.
• ages 13-21
• current diagnosis of depression
• prior history of either thoughts about suicide, or suicidal behaviors (a suicide attempt or a planned attempt that was stopped before it began)
• must be able to communicate verbally and in writing in English
• parental permission is needed for participants aged 17 or younger
• must have reliable internet connection
• Active substance use in the past month
• Neurological disorders such as seizures, head injury
Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.
• any gender identity
• 11-17 years old
• past suicide attempt and/or current suicide ideation
• Autism Spectrum Disorder
• Cognitive Developmental Delay (IQ < 75 i.e.intellectual disability)
• diagnosis of Schizophrenia
Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
This research is being done to determine if a procedure done by the anesthesiologist, known as a paravertebral block, can decrease the chance of developing atrial fibrillation after surgery. The block consists of using a numbing medication delivered over time through two small tubes to specific spots on the upper back. There is evidence that this helps reduce the chance of atrial fibrillation after similar procedures and the potential complications of that condition.
• undergoing one of the following elective or urgent (but not emergency) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
• history of atrial fibrillation or flutter
• Infective endocarditis
• Left ventricular ejection fraction (LVEF) < 30%
• redo surgery
• unable to have a block because of local anesthetic allergy, bleeding problem
• Body mass index > 35kg/m2
• woman who is pregnant
Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).
• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients
Balance and walking problems in patients with Parkinson’s Disease do not respond well to the typical medication or surgical treatments. This research study uses five small wearable devices that attach to clothing and can measure the body’s location while performing walking tests, balance tests, and normal daily activities. By comparing patients with Parkinson’s Disease to people of similar age without Parkinson’s Disease, we hope to learn important differences relevant to the walking and balance problems in Parkinson’s Disease
• Anyone who has been diagnosed with parkinsonism including Parkinsons disease, Normal Pressure Hydrocephalus, or atypical parkinsonism
• Healthy adults of similar age as study participants
• people who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)
The purpose of the study is to see how aerobic exercise and cognitive training alone or together affect cognition, brain structure and function, and physical fitness over the course of 18 months.
• diagnosis of Mild Cognitive Impairment
• live in the community
• English speaking
• adequate vision
• physician confirms that exercise is safe
• stable on drugs affecting cognitive and psychological status
• able to have a MRI
• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury
Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.
• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Prospective quantitative kinematic assessment of patients with normal pressure hydrocephalus
The purpose of this research is to better understand balance and walking in patients with normal pressure hydrocephalus. Balance and walking problems in patients with normal pressure hydrocephalus do not respond well to the typical medication treatments. This research study uses small wearable devices that attach to your clothing and can measure your body’s location while performing walking and balance tests.
• People who have dementia of sufficient severity to impair their ability to make health-care decisions
• People who have other types of Parkinson's Disease
• People who are unable to stand without help
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.
• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry
Minnesota Neurogenetics Repository
This research study is for participants who have an inherited neuromuscular disorder or neurogenetic disorder, or family members who are unaffected by such disorders
• individuals with DNA repair disorders including Cockayne syndrome, trichothiodystrophy, and xeroderma pigmentosum
• family members with a genetic neurological or muscle disease
• none
DegenPRO: A multicenter prospective registry for the management of degenerative spine disorders
This registry will be used to gather specific information about patients diagnosed with a degenerative spine disorder. Patient registries are observational studies that focus on understanding how the treatments, tests, and services, that are used in routine clinical care and by specialists, affect patient health outcomes. A registry that is appropriately designed, conducted, and analyzed will provide unique scientific information about the effectiveness, safety, and quality of the health-care service or intervention that is being studied.
• diagnosed with a degenerative spine disorder and receiving treatment
Improving Diagnosis and Treatment in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
This is a multi-center, prospective, observational cohort registry study looking at kids and their relatives with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
• anyone diagnosed with CPVT before 19 years of age.
• significant medical history that isn't related to CPVT
The (IRAD) International Registry for Acute Aortic Dissection (CCMOCPAAD)
The International Registry of Aortic Dissection (IRAD) was created in 1996 by cardiovascular specialists committed to expanding current knowledge of aortic dissection with the goal of improving patient outcomes. This registry study uses a standardized form to capture data from consecutive patients with aortic dissection at participating hospitals.
• 18 to 80 years of age
• clinical diagnosis of acute aortic dissection
• Type A dissection
• Type B dissection
• Retrograde type B dissection
• Aortic aneurysm
• Myocardial infarction
• Cerebral accident
• Active infection
Neural Bases of Disgust Conditioning in Anorexia Nervosa
We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.
• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
Longitudinal Study of Porphyrias
The objective is to conduct a longitudinal investigation of the natural history, complications, and therapeutic outcomes in people with acute and cutaneous porphyria.
• patient of any age
• diagnosis of a porphyria
• biochemical findings, as documented by laboratory reports of porphyria-specific testing performed after 1980
• elevations of porphyrins in urine, plasma or erythrocytes due to other diseases
Corrona Inflammatory Bowel Disease (IBD) Registry
This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.
• at least 18 years old
• Diagnosis of one of the following by a gastroenterologist: Crohn's disease or Ulcerative colitis (UC)
• users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease
• Participating in or planning to participate in a clinical trial studying new medications for Crohn's disease or Ulcerative colitis
Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation
This study is comparing the benefits and adverse effects of two delivery methods to help patients relax and decrease anxiety during his/her time on mechanical ventilation. This study is not examining the medication but rather the process of how the patient receives the sedation medication: patient controlled or usual care.
• receiving mechanical ventilation (ventilator) in the Intensive Care Unit
• receiving medication for sedation or pain
• prone (facing down) ventilation being used
• low blood pressure that is being treated with medication
• unstable medical condition (staff will review)
Focus in NeuroDevelopment (FIND) Network: A Statewide Network for Research in Neurodevelopment
The purpose of this research project is to develop a registry and database of families with neurodevelopmental disorders.
• All ages
• All individuals with disabilities and families within the neurodevelopmental disorder community
• Also looking for clinicians, educators, and professionals in the field
Graded Motor Imagery for Women at Risk for Developing Type I CRPS following Distal Radius Fractures
Background: Distal radius fractures (DRF) account for nearly one-fifth of all fractures in older adults, and women experience them 5x as often as men. Most DRF occur with low impact injuries to the wrist with an outstretched hand, and are often managed via closed treatment and cast immobilization. Women sustaining a DRF are at risk for upper limb immobility, sensorimotor changes, edema and type I complex regional pain syndrome (CRPS). Since CRPS onset is likely influenced by alterations in the brain’s somatosensory region, a rehabilitation intervention, Graded Motor Imagery (GMI), aims to restore cortical representation, including sensory and motor function, of the affected limb. To date, there are no studies on the use of GMI in reducing risk of or preventing the onset of type I CRPS in women with DRF treated with cast immobilization. Due to a higher likelihood of women with this injury developing type I CRPS, it is important to early intervention is needed. Methods/Design: This article describes a six-week randomized comparative effectiveness trial, where the outcomes of a modified GMI program (mGMI) + standard of care (SOC) group (n=33) are compared to a SOC only control group (n=33). Immediately following cast immobilization, both groups participate in four 1-hour clinic-based sessions, and a home program for 10 minutes three times daily until cast removal. Blinded assessments occur within 1 week of cast immobilization (baseline), at three weeks post cast immbolization, cast removal, and at three months post cast removal. The primary outcomes are patient reported wrist/hand function and symptomology on the Patient Rated Wristand Hand Evaluation, McGill Pain Questionnaire, and Budapest CRPS Criteria. The secondary outcomes are grip strength, active range of motion as per goniometry, circumferential edema measurements, and joint position sense. Discussion: This study will investigate the early effects of mGMI + SOC hand therapy compared to SOC alone. We intend to investigate whether an intervention, specifically mGMI, used to treat preexisiting pain and motor dysfunction might also be used to mitigate these problems prior to their onset. If positive effects are observed, mGMI + SOC may be considered for incorporation into early rehabilitation program.
• age 55 and older
• received closed treatment of distal radius fractures
• central nervous system disorders (e.g., Brain injury, Spinal Cord Injury, Parkinson's, Multiple Sclerosis)
• surgical fixation of fracture
• non english speaking
• multiple fractures to the same arm
• conditions of the opposite upper limb which would result in painful and markedly limited active hand, wrist and forearm motion
• cognitive disorders which make it difficult to follow testing commands and home program participation
• significant visual impairment
Synergistic Enteral Regimen for Treatment of the Gangliosidoses (SYNER-G) (Syner-G)
The Syner-G regimen research study seeks to evaluate the use of a combination of a medication called miglustat and a ketogenic diet for treatment of the gangliosidoses to learn if this combination will provide improved clinical outcomes compared to what we currently know about the natural course of the disease.
• no more than 17 years old
• documented infantile or juvenile gangliosidosis disease
• severe kidney disease
• females who are pregnant or breast feeding
• females who are post puberty who are unwilling to use highly effective birth control
A Natural History Study of the Gangliosidoses
This is a research study documenting the natural history of disease in patients with GM1 or GM2 gangliosidosis. The information collected will be a way to evaluate disease progression and create a disease stage and severity index. Our goal is to use the data collected to measure the effectiveness of any treatments that are developed in the future.
• documented gangliosidosis disease
• able to complete neuropsychological and neurobehavioral assessments
• Late-onset gangliosidosis subjects must be able to tolerate MRI of the head
• none
Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients with Locally Advanced or Metastatic Solid Tumors
This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.
• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breastfeeding
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration- Resistant Prostate Cancer Previously Treated With Chemotherapy
This is a research study designed to test how well a new medication (xaluritamig) works compared to other treatments for people with metastatic castration-resistant prostate cancer. These patients have already been treated with a certain chemotherapy. Participants will be randomly assigned to one of two groups: xaluritamig or either cabazitaxel (existing cancer treatment) or another treatment chosen by the doctor. The goal of the study is to find out which treatment is more effective and safer for patients.
• diagnosis of adenocarcinoma of the prostate
• evidence of progressive disease
• completed requirements for previous treatment
• may not be able to do strenuous activity but able to walk and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
• history of central nervous system (CNS) metastasis
• significant side effects from previous treatment that haven't resolved
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)
This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.
• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
National Liver Cancer Screening Trial (TRACER)
Finding liver cancer early is important to increase chances of getting treatment and decreasing risk of dying from cancer. The purpose of this research is to compare the effectiveness of two liver cancer screening methods to detect liver cancer at an early stage. Participants will be randomly (by chance) placed in one of two study groups – one group will undergo ultrasound imaging of the liver with or without a blood test to measure a specific protein, whereas the second group will undergo a blood test for liver cancer screening called a GALAD score. The GALAD score combines three blood tests to screen for liver cancer. We do not currently know if GALAD would help detect liver cancer earlier than standard screening.
• 18 to 85 years old
• diagnosis of cirrhosis of the liver of any cause, or Hepatitis B
• physician has determined patient is eligible for for hepatocellular carcinoma (HCC) screening
• history of liver cancer or clinical symptoms of liver cancer
• presence of another active cancer besides skin cancer
• history of organ transplant
• active listing for liver transplant
• history of alcohol related liver inflammation within 3 months
• known pregnancy at the time of consent
• active warfarin use
ACNS2321; A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas
This study aims to reduce the radiotherapy (RT) dose necessary to successfully treat patients with intracranial germ cell tumors who are in a state of complete response (CR) following chemotherapy. In this study, a further reduction in whole ventricular irradiation (WVI) will be tested. The primary aim of the study is to determine whether 12 Gy of WVI, and 12 Gy tumor boost, would be successful. Event-free survival (EFS) in patients with central nervous system germinoma, who meet criteria for CR or continued complete response (CCR) following chemotherapy/second-look surgery, would be the primary measurement of success.
• Age: Patients must be ≥ 3 years and < 30 years at the time of study enrollment. Diagnosis:
• Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGβ 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required.
• Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (DI) AND hCGβ ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required.
• Patients with hCGβ 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required.
• Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible.
• Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible.
• Patients with germinoma admixed with mature teratoma are eligible.
• Patients with any of the following malignant pathological elements are not eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed GCT (i.e., may include some germinoma).
• Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible.
• Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible.