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409 Study Matches

MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

This study is evaluating the efficacy of MultiStem (drug) on functional outcome in participants with ischemic stroke.

Muhammad Affan
18 years and over
This study is NOT accepting healthy volunteers
STUDY00008000
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Inclusion Criteria:

• clinical diagnosis of ischemic stroke involving cerebral cortex
• moderate to moderately severe stroke with a persistent neurologic deficit
Exclusion Criteria:

• stroke involving other areas of the brain
• stroke or head injury within the past 6 months
Brain & Nervous System
Ischemic Stroke, Stroke
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Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients with EPI due to Chronic Pancreatitis (CP) (CisCP)

CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions

Guru Trikudanathan
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012592
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Inclusion Criteria:

• at least 18 years old
• history of chronic pancreatitis (CP).
• diagnosis of Exocrine Pancreatic Insufficiency (EPI)
Exclusion Criteria:
-history of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Exocrine Pancreatic Insufficiency (EPI)
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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
This study is also accepting healthy volunteers
STUDY00015206
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Inclusion Criteria:
Patients with adductor laryngeal dystonia and:
• experienced improvement in voice quality following injection of botulinum toxin into the thyroarytenoid complex
• received their most-recent injection within 6 months
• age 18-80 years old
• able to read and write in English
• For Healthy Controls:
• age 18-80
• have no known voice problem
• able to read and write in English Patients with Muscle Tension Dysphonia:
• Age 18-80 (age-and sex matched to adductor laryngeal dystonia)
• Diagnosis of primary muscle tension dysphonia by a laryngologist and speech pathologist in the ?...absence of current organic vocal fold pathology, [and] without obvious?neurologic etiology.?18
• Able to read and write in English
• Muscle tension dysphonia patients who either haven?t started voice therapy, or for whom symptoms persisted despite voice therapy
Exclusion Criteria:
For people with adductor laryngeal dystonia, Muscle Tension Dysphonia and healthy controls:
• 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
• prisoners
• 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 or obstruction
Ear, Nose & Throat
Clinics and Surgery Center (CSC)
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CureGN: Cure Glomerulonephropathy Network Version 2.0

The purpose of CureGN2 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.

Michelle Rheault
Not specified
This study is NOT accepting healthy volunteers
SITE00000840
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Inclusion Criteria:

• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
Exclusion Criteria:

• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy: diabetes mellitus (except gestational or diet controlled), diabetic glomerulosclerosis, systemic lupus erythematosus, HIV infection, active malignancy (except for non-melanoma skin cancer), active Hepatitis B or C infection, defined as positive viral load
Kidney, Prostate & Urinary, Rare Diseases
Kidney, Glomerular Disease
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MAYFLOWERS-0B-20: A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS) (MAYFLOWERS)

This study is being done to look at how pregnancy affects the health of women with cystic fibrosis (CF) and to look at the health of babies born to women with CF. It is expected that most but not all women will be taking the newest CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator medication called TRIKAFTA®. It is not known how this medication will affect the health of mother and infant.

Joanne Billings
16 years and over
This study is NOT accepting healthy volunteers
SITE00001209
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Inclusion Criteria:

• at least 16 years old
• pregnant, intending to continue pregnancy
• enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Exclusion Criteria:

• none
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), Cystic Fibrosis, Pregnancy
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Post-contracture release radiation for Dupuytren's disease

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Kathryn Dusenbery
18 years and over
This study is NOT accepting healthy volunteers
STUDY00002191
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Inclusion Criteria:

• at least 18 years old
• diagnoses of Dupuytren's disease
• English-speaking
Exclusion Criteria:

• people who have Dupuytren's disease and are not currently seeking treatment
Dupuytren Contracture, Dupuytren's Disease
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Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)

This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.

Marie Hickey
18 years and over
This study is also accepting healthy volunteers
STUDY00016313
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Inclusion Criteria:

• pregnant women in their second or third trimester with a diagnosis of gestational diabetes
• screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) with screening done between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive a oral glucose tolerance test (OGTT)
• BMI 18.5-45 kg/m2 at first prenatal visit
• age 21-45 at time of delivery ? Pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior) ? Singleton pregnancy
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy or lactation
• inability to speak and understand English
• known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• history of type I Diabetes
• mothers currently taking over the counter probiotic preparation
Women's Health
women's health, pregnancy, pregnant women, gestational diabetes
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Liver Collection Study

This is a study of individuals older than 18, undergoing abdominal procedures in which the liver is accessible, and are amenable to liver samples being collected during their surgical procedure, with the option to participate in a specialized scan that can provide information on liver health, stiffness, and fat content. This study is trying to figure out how senescent (aging) cells in the liver are related to an individual's health status and better understand the association between these cells and different metabolic diseases.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013764
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Physician may exclude
Diabetes & Endocrine, Digestive & Liver Health, Prevention & Wellness
abdominal surgery, liver biopsy
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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study (CHOLINE4)

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
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00000121
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Inclusion Criteria:

• ages 2.5 years to 5 years old (<6 years of age)
• prenatal alcohol exposure
Exclusion Criteria:

• history of a neurological condition (epilepsy, traumatic brain injury)
• history of a medical condition known to affect brain function
• other neurodevelopmental disorder (autism, Down syndrome)
• history of very low birthweight (<1500 grams)
Mental Health & Addiction
Fetal Alcohol Spectrum Disorders
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COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)

This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00000331
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Inclusion Criteria:

• between 11 years and 45 years old
• primary arising in testis, ovary, retro-peritoneum, or mediastinum
• metastatic disease or non-testicular primary
• see link to clinicaltrials.gov for completed Inclusion/Exclusion criteria
Exclusion Criteria:

• other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
• significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
• peripheral neuropathy equal or greater than grade 2 or clinically significant sensorineural hearing loss or tinnitus
Cancer
Germ Cell Tumor
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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.

Joanne Billings
Not specified
This study is NOT accepting healthy volunteers
1702M07621
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Inclusion Criteria:

• at least 12 years old
• documented diagnosis of Cystic Fibrosis (CF)
• willing to travel (if needed) to a regional study site for cell collection
Exclusion Criteria:

• presence of a medical condition, abnormality, or laboratory value that would place the participant at risk (study staff will review)
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), CF, Cystic Fibrosis
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Pediatric COVID-19: Does infection with the SARS-CoV-2 virus alter brain structure and function?

The goal of the proposed project is to investigate whether brain abnormalities are present in children to young adults after the recovery from coronavirus disease 2019 (COVID-19).

Igor Nestrasil
Not specified
This study is NOT accepting healthy volunteers
STUDY00010688
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Inclusion Criteria:

• diagnosis of COVID-19 in the past
• experiencing long covid symptoms for at least 2 months
• 3 to 25 years old at the time of entry into the study
Exclusion Criteria:

• active positive COVID-19 diagnosis (as confirmed by a medical provider &/or certified testing site) for at least 4 weeks prior to projected enrollment date
• surgically implanted pacemaker
• indwelling electronic device, including programmable shunts
• orthodontic braces, unless non-metallic
• implanted metal in the body other than titanium
• inability or unwillingness to complete an MRI
• pregnancy
• anyone not meeting standard MRI requirements according to CMMR protocol (ie presence of metal in body or implanted pacemaker) will be excluded from that portion of the study
COVID-19
long covid, COVID-19, Pediatric, MRI
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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Stephen Huddleston
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003837
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Inclusion Criteria:

• people who received OCS preserved double lung transplants
• OR people who receive a single lung transplant from OCS preserved lung pairs from either standard criteria donors
• AND all donor lungs that were perfused on OCS Lung System
Brain & Nervous System
Clinics and Surgery Center (CSC), Lung Transplant
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Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK OFF JSpA) (BACK-OFF JSpA)

This study is enrolling participants who have been diagnosed with juvenile spondyloarthritis, are taking a tumor necrosis factor inhibitor (TNFi) and have reached a clinically inactive disease state for a minimum of six months. Researchers want to know if children who have maintained inactive disease for at least 6 months can maintain quiet disease without taking their medication as frequently or stop the TNFi therapy. Quiet disease means that disease related symptoms are not active or being experienced in the patient. Researchers also want to know the safest method to bring patients off medication. If a flare does occur during therapy reduction, researchers want to find out whether they can predict when a flare is most likely to happen, and how quickly an inactive disease state can be recaptured.

Colleen Correll
Not specified
This study is NOT accepting healthy volunteers
SITE00001260
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Inclusion Criteria:

• age 8 to 21 years
• juvenile SpA diagnosis symptom with symptoms starting before their 16th birthday
• currently taking one of the following therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses
• have reached a clinically inactive state for at least 6 months
• English speaking or Spanish speaking
• willing to taper off medications
Exclusion Criteria:

• History of inflammatory bowel disease or history of uveitis
• psoriasis that started before TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Arthritis & Rheumatic Diseases, Children's Health, Rare Diseases
arthritis, Juvenile Spondyloarthritis
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Bone as Regulator of Energy Balance and Male Fertility after SCI: A Pilot Study (Osteocalcin Protocol)

This study will evaluate if there is a relationship between bone health, fertility, and metabolism to help develop future treatments for SCI. Both men with and without SCI will be participating in this trial to better understand how bone health, fertility, and metabolism are impacted by an injury to the spinal cord.

Leslie Morse
18 years and over
This study is also accepting healthy volunteers
STUDY00011054
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Inclusion Criteria:

• Male age 18-50
• diagnosis of motor complete spinal cord injury (SCI)
• completed inpatient rehabilitation and living in the community
• use a wheelchair as primary mobility mode -English and non-English speakers
• For healthy volunteers: male age 18-50, able to walk independently, English and non-English speakers
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)
• study team will review additional exclusion criteria
• for Healthy Volunteers: presence of neurological condition, metabolic bone disease, thyroid disorder, current use of medications that potentially affect bone healthy, osteoporosis, diabetes, infertility, or other medical conditions (study staff will review)
Brain & Nervous System
Spinal Cord Injury
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COG AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

This phase II trial studies how well combination chemotherapy works in treating patients (≤ 30 years old) with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).This trial may help doctors find out what effects, good and/or bad, regimen UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT)and regimen ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Emily Greengard
Up to 30 years old
SITE00001038
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Inclusion Criteria:
Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN03B2 and have received an initial risk assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a delayed nephrectomy classification showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on AREN03B2 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor. Patients must be =< 30 years old at study enrollment Patients with the following diagnoses are eligible for this study: Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy: Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have a life expectancy of >= 8 weeks Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations: Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the AREN03B2 initial risk assignment results (if available per current version of AREN03B2) Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment) Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment) Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment) Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment) Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement: Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment) Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table: Age: Maximum Serum Creatinine (mg/dL) 1 month to < 6 months: 0.4 (male and female) 6 months to < 1 year: 0.5 (male and female) 1 to < 2 years: 0.6 (male and female) 2 to < 6 years: 0.8 (male and female) 6 to < 10 years: 1 (male and female) 10 to < 13 years: 1.2 (male and female) 13 to < 16 years: 1.5 (male), 1.4 (female) >= 16 years: 1.7 (male), 1.4 (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment) Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment) Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)
Exclusion Criteria:
Patients with a history of bilateral Wilms tumor (synchronous or metachronous) Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy For patients with high-risk or very high-risk relapsed FHWT: Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate =< 2 mg/dL (or < 0.8 mmol/L) without supplementation For stages 2-4 DAWT and standard-risk relapsed FHWT patients: Chronic inflammatory bowel disease and/or bowel obstruction Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
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Remote State Representation in Early Psychosis (Rem-STEP) (Rem-STEP)

The purpose of the current study is to test the effects of two forms of cognitive training: visual perception training or visual cognitive control training in individuals with early psychosis.

Melissa Fisher
18 years and over
This study is NOT accepting healthy volunteers
SITE00001497
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Inclusion Criteria:

• people who have Schizophrenia, Schizoaffective disorder, Psychosis, Major depressive disorder with psychotic features, or Bipolar disorder with psychotic features
• between ages 18 and 30 except: Alabama & Nebraska 19 to 30 and Mississippi 21 to 30
• able to read and speak English,
• no hospitalizations for mental health issues in the past month
• have access to a computer with internet connection
• permanent resident of the United States
Exclusion Criteria:

• history of substance abuse in the past month
• diagnosed with a neurological disorder
• cognitive training in the past 6 months
Mental Health & Addiction
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Natural History Study for DNA Repair Disorders

This research is being done to help us better understand the different DNA repair disorders. We will collect data and samples that we will use to develop new therapies and medicine to help treat the disease. We expect that participants will be in this research study for 3 years. Visits will occur every six months and alternate between in-person and remote. Remote visits should be expected to last 1-2 hours, and in-person visits should be expected to last 3-4 hours.

Peter Kang
Not specified
This study is NOT accepting healthy volunteers
STUDY00015911
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Inclusion Criteria:

• at least 6 months old
• diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics
• have one or more of the neurodevelopmental or neurological complications such as gross motor delay, language delay, altered muscle tone (study staff will review)
• family member of an individual with the above condition
Exclusion Criteria:

• prior history of systemic gene or cell-based therapy
• participation in a clinical trial for treatment
Rare Diseases
Cockayne Syndrome, DNA Repair Disorder, Trichothiodystrophy, Xeroderma Pigmentosum
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State Representation in Early Psychosis (STEP)

In the first phase of the study, participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews and questionnaires about their life experiences and mental health, and they will have an EEG and fMRI while completing computerized tasks. The second phase of the study is optional. In this phase, participants will test one of two forms of computerized cognitive training, or brain games. They will be asked to complete 10 hours of training over a 3-6 week period. After the training period is over, they will have two sets of follow up visits, one right after the training period and one five months later. At these appointments, participants will complete the same activities done in the first phase of this study, including the interviews, questionnaires, and imaging (fMRI and EEG) combined with computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

Sophia Vinogradov
Not specified
This study is also accepting healthy volunteers
STUDY00009964
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Inclusion Criteria:

• able to speak and write English
• 15 to 40 years old
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis, with psychotic symptoms starting in the past 5 years
• no hospitalizations and on stable doses of medications for the past one month or more
• For healthy volunteers without a mental health diagnosis: will match on age, sex, etc. to people enrolled in the study.
Exclusion Criteria:

• currently pregnant
• history of neurological disorder
• previous head injury with loss of consciousness
• currently suicidal or has attempted suicide in the past 6 months
Mental Health & Addiction
Psychosis, Schizoaffective Disorder, Schizophrenia
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Asymmetries in motor control and their impact on functional independence

We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.

Shanie Jayasinghe
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015809
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Inclusion Criteria:

• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
Exclusion Criteria:

• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Brain & Nervous System, Community Health, Heart & Vascular
stroke, chronic, independence, movement, hemiparesis, deficits, rehabilitation, neuroscience
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Site for ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

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

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

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

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

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

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

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

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

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

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

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

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

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

Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.

Colum MacKinnon
18 years and over
This study is also accepting healthy volunteers
STUDY00011162
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Inclusion Criteria:

• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
Exclusion Criteria:

• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson?s disease, or a family member with a diagnosis of Parkinson?s disease.
Brain & Nervous System
Parkinson's
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Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy (MARVEN Study)

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

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

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

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

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

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

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

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

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

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

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

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

Charles Lewis
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00011433
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Inclusion Criteria:

• ages 13-21
• current diagnosis of depression
• prior history of either thoughts about suicide, or suicidal behaviors (a suicide attempt or a planned attempt that was stopped before it began)
• must be able to communicate verbally and in writing in English
• parental permission is needed for participants aged 17 or younger
• must have reliable internet connection
Healthy volunteers
also needed
Exclusion Criteria:

• Active substance use in the past month
• Neurological disorders such as seizures, head injury
Children's Health, Mental Health & Addiction
Depression, Suicide, Adolescent
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Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

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

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

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

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

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

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

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

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