Search Results
Sightline: Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.
The main purpose of the study is to collect blood samples and medical information to help Nucleix in the development of an investigational test that aims to differentiate between individuals at high risk with and without lung cancer.
• Current or past smokers, with at least 20 pack-years
• People who have with either a high suspicion for lung cancer, with surgery planned for biopsy or removal
• People who have lung cancer that hasn't been treated yet
• People who have diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
• Current lung cancer is known to be stage III or IV by pathology.
• People having regular screening to monitor a lung nodule
Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Patients with Overactive Bladder
This study will evaluate treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of OAB in the context of real-world clinical practice.
• diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• symptoms of OAB for at least 3 months
• specific previous treatments for OAB (study staff will review)
• neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• women who are pregnant or breast feeding or planning to become pregnant
RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)
We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.
• at least 12 years old
• documented diagnosis of Cystic Fibrosis (CF)
• willing to travel (if needed) to a regional study site for cell collection
• presence of a medical condition, abnormality, or laboratory value that would place the participant at risk (study staff will review)
Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression
This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-55 years old with Medicare or Medicare Advantage insurance.
• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111
We are looking at the effectiveness of adding an immunotherapy drug, pembrolizumab, to usual treatment for people who have salivary gland cancer that can’t be treated with surgery or radiation. The cancer must be androgen receptor positive.
• at least 18 years old
• locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
• tumor is androgen receptor-positive
• unable to do physically strenuous activity but can walk and is able to do work of a light nature, such as house work or office work
• prior chemotherapy, radiation, or surgery as part of curative intent therapy are allowed
• any number of prior lines of systemic therapy are permitted as long as it did not include anti-androgen therapy or immune checkpoint blockade
• men and women of child bearing age must agree to use contraception during the treatment period and for at least 8 months after the last dose of study treatment
• contact study staff for additional requirements
• received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
• received prior androgen deprivation therapy
• pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the first visit through 120 days after the last dose of trial treatment.
• additional cancer that is progressing or has required active treatment within the past 2 years
• contact study staff for additional exclusion criteria
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)
To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)
• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
MT2023-06: A CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LERIGLITAZONE IN ADULT MALE SUBJECTS WITH CEREBRAL ADRENOLEUKODYSTROPHY (CALYX)
This study has 2 parts: a double-blind period and an open-label extension. In the double-blind period of this study, the study medicine will be compared to a placebo. A placebo is a treatment that looks and tastes exactly like the study medicine but does not contain any active ingredient. In this study, you will receive leriglitazone or placebo. Whether you receive leriglitazone or placebo will be decided randomly (by chance, like flipping a coin). In this study, 1 out of every 2 subjects (50%) will receive leriglitazone and 1 out of every 2 subjects (50%) will receive placebo. To make this study fair, you and the study doctor will not be told which treatment you will receive, this is called “blinding”. In the open-label extension, all subjects will receive leriglitazone.
• diagnosis of progressive cerebral adrenoleukodystrophy (cALD), defined as GdE with brain lesions
• bone marrow transplantation (HSCT) is not recommended patient is not willing to undergo HSCT
• no major cognitive impairment
• see link to clinicaltrials.gov for additional inclusion criteria
• or treatment with ex-vivo gene therapy (eli-Cel).
• known type 1 or type 2 diabetes
• see link to clinicaltrials.gov for additional exclusion criteria
MT2022-56: A Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma
The purpose of this study is to test the safety of FT576 at different doses and schedules and to understand the way the body processes and responds to FT576. The study will also find out what effects FT576, when given alone (also called monotherapy) or in combination with an anti-cancer drug (called a monoclonal antibody), may have on you and your cancer. FT576 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells.
• diagnosis of multiple myeloma after 3 or more previous treatments
• able to complete activities of daily living with minimal help
• history of significant heart disease
• low red or white blood counts
• abnormal liver function tests
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.
• 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
• 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)
A Phase IB/II Multi-Cohort Study of Targeted Agents with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer (EndoMAP)
The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.
• recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy
• primary invasive ovarian or cervical cancer occurring with this cancer
• other cancer occurring in the past 5 years
• active or history of autoimmune disease or immune deficiency
• history of cardiac, respiratory or neurological conditions (study staff will review)
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104
This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.
• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'
The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.
• 21 years or older
• Daily user of tobacco or nicotine products
• Unstable health condition
• Pregnant or nursing
Profiling of Adipose Tissue Depots and Immune Correlates
This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.
• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Genetics of Developmental Disorders - Data and Specimen Repository
This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.
• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Genetic Modifiers and Glycemic Variability in Turner Syndrome
This study is looking at glucose (blood sugar) patterns in participants with Turner Syndrome between the ages of 3-80 years old. This will be done by obtaining 2 hours frequent blood sampling by completing an Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test. Participants will also wear a continuous glucose monitor for 2 weeks. Along with the OGTT and MMTT, participants are asked to provide a blood sample for DNA and RNA testing. Participant’s parents are asked to provide a saliva sample for DNA testing
• Participants with a diagnosis of Turner syndrome by karyotype
• Ages 3 to 80
• Additional genetic diagnosis detected on karyotype, CMA, or FISH
• Prior diabetes diagnosis
• Current or recent (last 72 hours) use of systemic glucocorticoids
• Current use of hypoglycemic agents
• History of solid organ or bone marrow transplant
• Currently pregnant
• Non English-speaking
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.
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Psilocybin is the perception-altering drug found in ‘magic mushrooms’ and we want to learn more about visual perception in people taking psilocybin and how these relate to brain functions. Participants will be given an investigational study drug during 2 visits and asked to come in for a total of 7 study visits. Participants will also be required to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
• 25-65 years of age
• have at least a high school education (GED ok) and able to speak and write English
• experience taking psilocybin
• in good physical and mental health with BMI between 20.0 and 28.0 kg/M2
• have someone who can drive to study sessions at the University of MN
• live within 1 hour driving distance of the University of MN
• agree not to use any recreational drugs while in the study ( for example, hallucinogens, ketamine, and marijuana)
• current or past history of a mental health issue
• currently taking any prescription medications on a daily basis, except birth control pills
• pregnant or breast feeding
• can't have a MRI
Stress Response and Opioid Dysfunction in Nicotine Dependence
This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.
• Live in Minnesota.
• Between 18-70 years old.
• Generally healthy.
• Want to quit using tobacco and nicotine.
• Are willing to attend up to 11 online (videoconference) study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year).
• Do not live in Minnesota.
• Not between 18-70 years old.
• Not willing to attend to up to 11 online (videoconference) study visits over a period of approximately 4 months.
Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy
This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.
• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
• 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)
MT2023-42: A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.
• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ?2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
HEALEY ALS Platform Trial
The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. We are doing this research to find out if different treatments have an effect on Amyotrophic Lateral Sclerosis (ALS). We also want to find out if these treatments are safe to take without causing too many side effects.
• 18 years or older
• diagnosed with sporadic or familial ALS
• weakness started no more than 36 months ago -able to to swallow pills and liquids
• unstable medical or mental health condition
• limitations on prior or current use of certain medications (study staff will review)
• women who are pregnant or breast feeding
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity
In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribed meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.
• severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• 12 to less than 18 years of age at enrollment
• female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
• diabetes (type 1 or 2)
• current or recent (< six months prior to enrollment) use of anti-obesity medication(s) (use of naltrexone or bupropion alone is not an exclusion)
• previous metabolic/bariatric surgery
• current use of a stimulant medication
• history of glaucoma
• current or recent (<14 days) use of monoamine oxidase inhibitor
• history of treatment with growth hormone
• history of bulimia nervosa
• major psychiatric disorder
• any history of active suicide attempt
• history of suicidal ideation or self-harm within the previous 30 days
• current pregnancy or plans to become pregnant during study participation
• current tobacco use
• history of cardiac, endocrine, kidney disease (study staff will review)
MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases
This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.
• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis
This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis.
• age 18-80
• contact umnsarc@umn.edu for inclusion/exclusion criteria
• history/current use of cigarette, e-cigarette, vaping or marijuana smoking
• history/current use of nicotine products
• presence of underlying chronic condition
• inability to undergo procedure using IV sedation
• weight < 110 lbs. & BMI > 35 kg/m2
• pregnant and/or breast feeding
• history/current use of chronic immunosuppressive medications
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Tissue biopsies for the study of FSHD
A single visit study with muscle and/or skin biopsy / blood draw, performed to determine whether a molecular or cellular defect can be attributed to cells of Fascioscapulohumeral Muscular Dystrophy (FSHD) muscle. This study is recruiting both individuals with genetically confirmed FSHD as well as unaffected healthy (control) individuals.
• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
Increasing HPV vaccination coverage among pediatric, adolescent, and young adult (PAYA) cancer survivors: A multilevel intervention
The purpose of this research is to test the efficacy of different interventions to increase vaccination against human papillomavirus (HPV). Survivors of childhood, adolescent and young adult cancers are at increased risk of developing HPV-associated secondary cancers, but have lower HPV vaccination coverage compared to the general population. Interventions which are found to be successful in this study will be incorporated into future survivorship care to improve adherence to recommend preventive healthcare practices. All research procedures will be conducted remotely (e.g. online).
• current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic
• seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder
• survivor of childhood cancer (diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age
• at least 6 months post-treatment (current treatment for graft-versus-host disease allowed)
• no previous HPV vaccination or incomplete HPV vaccination
• people who are unsure of their HPV vaccination status and are unable to find vaccination records (study staff will review)
• previously completed HPV vaccination series
• unable to read and write in English
• pregnant or plans to become pregnant in the next year
• currently receiving treatment for cancer or hematologic disorder or plan for treatment in next 12 months
• immediate hypersensitivity reaction to any vaccine component (study staff will review)
Robotic Gait Training to Improve Functional Outcomes after SCI
We are researching the benefits of physical therapy guided exoskeleton gait training in people with a spinal cord injury. We want to describe the benefits to overall function and how the brain changes after gait training.
• spinal cord injury level C7-T12
• medically stable, no acute issues that would prevent gaiting
• motor complete (AIS A or B) spinal cord injury OR motor incomplete (AIS C or D) spinal cord injury who use a wheelchair for more than 50% of personal mobility
• height between 155-191cm (5'1" to 6'2")
• weight less than 113kg (248 pounds)
• sufficient upper body strength to complete sit-to-sit transfers
• women of childbearing age must agree to use contraception during study participation
• women who are pregnant
• symptomatic orthostatic hypotension
• active Grade 2 or greater pressure ulcer that can be potentially worsened by use of an exoskeleton
• lower extremity contractures that interfere with wearing an exoskeleton
• unhealed lower extremity fracture
• history of neurologic diseases (e.g. stroke, peripheral neuropathy, myopathy)
• active treatment for epilepsy or thyroid disorders
• women with osteoporosis at baseline by DXA scan
Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3 (SPARX3)
The purpose of this study is to compare the effects of 2 different levels of exercise intensity and to learn more about effects of aerobic exercise for people with Parkinson’s disease (PD). This study will help us better understand what exercise guidelines should be used in the future.
• 40 to 80 years old
• diagnosis of idiopathic Parkinson Disease (PD)
• less than 3 years since disease diagnosis
• currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics
• expected to start medication within six months of starting the study
• previous use of medications for PD for more than 60 days
• exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months
• known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program
• uncontrolled hypertension (resting blood pressure greater than 150/90 mmHg)
• any medical, mental health, drug or alcohol abuse, assessment or laboratory abnormality that indicates a problem that could limit ability to participate in the exercise program (study staff will evaluate)
• women who are breast-feeding, pregnant, or plan to become pregnant in the next 12 months
• unable to have a brain scan
Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)
People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.
• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review