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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

446 Study Matches

Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)

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.

Principal Investigator: Charles Billington Jr.
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011194
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Conditions: Brain & Nervous System, Rare Diseases, Children's Health
Keywords: Genetic disorders, developmental brain disorders, developmental disorders
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Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

Principal Investigator: Kristin Gravel
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00010956
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 4 to 14 and 11 months old
• parents and child fluent in English
• parents desire functional hearing in both ears for their child
• severe to profound sensorineural hearing loss in one ear and normal hearing in the other ear
• if older than 5 years, documentation of progressive hearing loss (i.e. passed newborn hearing screening, or significant change in hearing)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• already using a cochlear implant
Conditions: Ear, Nose & Throat
Keywords: Pediatric audiology, Audiology, Cochlear Implant, Single-Sided Deafness
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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization for people with chronic obstructive pulmonary disease (COPD). Participants will be randomly (by chance; like the flip of a coin) assigned to one of two groups. One group will receive usual medical care for COPD. The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily. Participants will complete daily COPD symptom reports. This research will last for at least 12 months and up to 24 months.

Principal Investigator: Nathaniel Gaeckle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001599
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 30 years old
• history of a severe COPD requiring hospitalization in the previous six weeks
• specific requirements for FEV1 and FVC (study staff will review)
• current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
• women of reproductive are are required to use highly effective contraception for at least 1 month prior to starting the study and agree to use such a method during study participation
• able to read and communicate in English
Exclusion Criteria:

• current use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• women who are pregnant or breast feeding
• recent upper airway surgery (within the previous month)
• recent head or neck trauma (within the previous month)
• require oxygen greater than at 15 L/min
• inability to tolerate nasal prongs
Conditions: Respiratory System
Keywords: COPD
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Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)

The purpose of the study is to see how restricting the eating window (called time-restricted eating) might affect eating habits, weight, and blood measures compared to reducing food intake. Time-restricted eating means that people would have a daily 8 hour eating window during which time they can eat whatever they want. Outside of the eating window, people would only take water and your medications. We expect that participants will be in this research study for about 7 months.

Principal Investigator: Lisa Chow
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014853
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 65 years old
• overweight/obese and have type 2 diabetes treated with diet or metformin
• BMI between 25-45 kg/m2
• HbA1c between 6.5-8.5%
• self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• own a smartphone
Exclusion Criteria:

• women who are pregnant or are planning to become pregnant
• eating disorders
Conditions: Diabetes & Endocrine
Keywords: Type 2 diabetes, intermittent fasting, caloric restriction, time restricted eating
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Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

Principal Investigator: Emily Nagel
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016926
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
Exclusion Criteria:

• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Conditions: Children's Health, Women's Health
Keywords: Breast Milk, Maternal Stress, Neurodevelopmental and Feeding, Preterm baby, Preterm feeding
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Dissecting the role of acetaldehyde in oral carcinogenesis

The goal of this study is to better understand how drinking alcohol may lead to oral cancers. Acetaldehyde, a chemical formed when the body breaks down alcohol, is believed to play an important role. This study will measure acetaldehyde and DNA damage levels in the mouth of participants after a low dose of alcohol. The levels will be compared between three groups, all having different degrees of risk for developing oral cancer, and with non-drinkers to identify DNA damage that might be important to cancer formation. We also want to understand how alcohol can affect the bacteria in our mouths and how that might impact oral DNA damage.

Principal Investigator: Silvia Balbo
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00012972
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Alcohol drinkers of Eastern Asian descent who experiences flushing (reddening or warming of face and chest) when drinking {ages 21 - 45}
• Alcohol drinkers who have Fanconi Anemia {ages 21+}
• Never drinkers {ages 18 - 45}
Exclusion Criteria:

• Tobacco or nicotine users
Conditions: Prevention & Wellness
Keywords: Alcohol, Fanconi Anemia, drinking, flushing
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mGlide-Care: A mHealth Partnership with caregivers to improve HTN management in patients with cognitive impairment

The purpose of this study is to learn about a new way of managing hypertension using a wireless blood pressure monitor and a smartphone. The goal is to improve hypertension care in older adults with memory loss or mild dementia in partnership with their caregiver.

Principal Investigator: Kamakshi Lakshminarayan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018765
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults ages 60-85 years
• diagnosis of hypertension
• diagnosis of mild cognitive impairment or early stage Alzheimer's Disease/Related Dementias
• participant has an unpaid family caregiver
Exclusion Criteria:

• severe comorbid illness including end-stage kidney disease, end-stage liver disease,
• participant and caregiver unable to complete study tasks or have plans to relocate in the next 12 months
• serious psychiatric illness that could interfere with treatment, assessment, or compliance
Conditions: Brain & Nervous System, Community Health, Heart & Vascular
Keywords: aging, blood pressure, caregiving, dementia, Hypertension, memory, Mild cognitive impairment
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Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease

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

Principal Investigator: Alexander Boucher
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018692
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 28 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
Exclusion Criteria:

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Conditions: Blood Disorders, Mental Health & Addiction
Keywords: SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

The purpose of this study is to determine whether active Vagal Nerve Stimulation (VNS) Therapy is better than no stimulation VNS Therapy in improving health outcomes for subjects with Treatment-Resistant Depression (TRD). All participants in this study will receive a VNS Therapy surgical implant, which works to reduce the symptoms of depression by sending mild electrical pulses to the vagus nerve in the neck. The vagus nerve is connected to areas of the brain associated with controlling the mood. Data will be collected on responses to study treatments, quality of life, productivity, and use of healthcare services.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000818
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• current diagnosis of major depression for at least two years or at least 4 episodes of major depression
• have an inadequate improvement in symptoms with at least 4 antidepressant treatments
• on at least one antidepressant with a stable drug schedule for at least 4 weeks
• enrolled in Medicare or Medicare Advantage
Exclusion Criteria:

• Currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
• acute suicide risk or suicide attempt within 6 months
• history of other major mental health diagnosis (staff will review)
• treatment with another device or experimental drug
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Depression, Major depression

Development of objective measures for multisensory effects on hearing

Paired sound and electrical stimulation can alter how the brain encodes sounds and the perception of sounds, as shown in emerging evidence from animal studies. The aim of this study is to develop measures for paired stimulation that can be used reliably. These measures assess the following aspects of hearing: basic hearing sensitivity and cochlear health, perception of loudness and pitch, and perception of speech and other complex sounds. This will lead to a greater understanding in the hearing science community about how multisensory stimulation can alter activity in the auditory system and sound perception, which may lead to new techniques for improving hearing disorders.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022175
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• not users of hearing aids or implanted devices
• normal hearing or hearing-impaired, with or without tinnitus
Exclusion Criteria:

• users of hearing aids or implanted devices
Conditions: Ear, Nose & Throat
Keywords: auditory plasticity, Hearing loss, neuromodulation, tinnitus, transcutaneous electrical stimulation
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Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults with Prediabetes

We are looking at how an 8-week exercise program of walking for 30-45 minutes 3 times/week affects the body. This study is for people who are prediabetic and overweight or obese. We will compare the exercise group to a group that didn’t participate in the exercise to see if there are differences in gut microbes, body measurements, and blood work.

Principal Investigator: Ryan Demmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00009136
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 30-64 years old
• classified as overweight or obese with BMI greater than 25 kg/m2
• physician diagnosed as pre-diabetic or HbA1c value of 5.7 - 6.4% obtained during study screening
• currently exercise less than 100 minutes per week
• physically able to exercise
• no antibiotics taken for at least 45 days
• weight has been stable for the last 6 months (less than 10% change)
• willing to maintain current diet and exercise levels unless changed by the study
Exclusion Criteria:

• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding
Conditions: Diabetes & Endocrine
Keywords: Prediabetes, elevated blood glucose, impaired glucose, blood sugar, obesity, Hemoglobin A1c, exercis
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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1608M93561
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:

• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Conditions: Brain & Nervous System
Keywords: aging, Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
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A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients

We are looking at the addition of nivolumab to chemotherapy compared to usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body. Immunotherapy, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells. Giving nivolumab with chemotherapy may help doctors find out if the treatment is better or the same as the usual approach.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC037
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• inoperable, recurrent, or metastatic anal cancer
• restricted from strenuous activity but can walk and are able to carry out work of a light or sedentary nature
• requirements for lab results at a defined level (study staff will review)
• history of significant heart disease
Exclusion Criteria:

• women who are pregnant or breastfeeding
• previous use of systemic chemotherapy or other investigational drugs
• prior immunotherapy
• active autoimmune disease or history of autoimmune disease
• other primary cancer within the last 3 years
• intermittent peripheral neuropathy
• additional exclusion criteria that study study will review
Conditions: Cancer
Keywords: Anal Cancer
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An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose PR001A in Infants with Type 2 Gaucher Disease

PR001A is designed to deliver a normal GBA1 gene copy into the body to increase the activity of GCase, which is low in Type 2 Gaucher Disease (GD2) patients. The new GBA1 gene will remain a child’s body cells for many years and possibly for the rest of their life. A participant will need one surgery during which the study drug will be given and will stay in the hospital for at least 48 hours following the surgery.

Principal Investigator: Chester Whitley, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00008823
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 0 to 24 months of age
• clinical diagnosis on Gaucher disease, Type 2 (GD2)
• Bi-allelic GBA1 mutation
• child has a reliable caregiver (i.e., parent/legal guardian) who is willing and able to participate in the study as a source of information on the patient's health status and cognitive and functional abilities
Exclusion Criteria:

• diagnosis of a significant CNS disease other than GD2
• able to walk independently
• any other significant medical diagnosis (study staff will review)
• significant laboratory test result abnormalities
• unable to tolerate diagnostic imaging (MRI, CT scan) or unable to tolerate contrast agent
• unable to have sedation or anesthesia
Conditions: Rare Diseases
Keywords: Gaucher disease, Type 2 (GD2)
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A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin (SkyPASS) (SkyPASS)

The purpose of this study is to evaluate the long-term safety and effectiveness of Skytrofa treatment in children growth hormone deficiency. Patient care will follow the normal treatment practices at the clinic. No additional visits will be performed beyond the usual clinical practice.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002030
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study for short stature
Conditions: Diabetes & Endocrine, Rare Diseases, Rare Diseases, Rare Diseases
Keywords: growth hormone and growth hormone deficiency

Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Principal Investigator: Sonya Wang
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020174
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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The TrialNet Natural History Study of the Development of Type 1 Diabetes

TrialNet is an international research group dedicated to the study, prevention, and early treatment of Type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of having two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the clinical diagnosis of Type 1 diabetes. This study will help us learn more about how Type 1 diabetes occurs through the screening of diabetes-related autoantibodies and monitoring individuals who have tested positive for these autoantibodies.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: SITE00000016
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 2.5 to 45 years old and have an immediate family member with type 1 diabetes (child, parent, or sibling)
• 2.5 to 20 years old who have an extended family member with type 1 diabetes (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:

• already have diabetes
• history of being treated with insulin or oral diabetes medications
• using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• have any known serious diseases
Conditions: Diabetes & Endocrine
Keywords: T1DM, Type 1 Diabetes

CMRR Healthy Participant Registry

The purpose of this Health Participant Registry is to collect the names, contact information and answers to safety screening questions that assist in the determination of magnetic resonance (MR) compatibility of individuals who have expressed interest in MR research.

Principal Investigator: Jeramy Kulesa
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: 00015977
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• English speaking
• able to have a MRI scan, must complete assessment
Exclusion Criteria:

• women who are pregnant
Keywords: Imaging, MRI
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Randomized Phase III Study of Combination AZD9291 (osimertinib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

This trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs and has a change (mutation) in a gene called EGFR. Sometimes, mutations in this gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly.

Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC040
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
• have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive therapy, or recurrent disease
• no prior systemic treatment for metastatic disease
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional inclusion criteria (study staff will review)
Conditions: Cancer
Keywords: Lung Cancer, Non-Squamous Non-Small Cell Lung Cancer, NSCLC, Stage III or Stage IV Lung Cancer
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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.

Principal Investigator: Michael Kyba
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00000409
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
Exclusion Criteria:

• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
Conditions: Rare Diseases, Heart & Vascular
Keywords: Fascioscapulohumeral Muscular Dystrophy (FSHD), Clinics and Surgery Center (CSC)
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NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC043
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
Exclusion Criteria:

• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Conditions: Brain & Nervous System, Cancer
Keywords: Brain Cancer, Brain Cancer, Glioblastoma
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Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting (DiRECT)

This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC058
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA), or Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• current diagnosis of invasive cancer at stage I-IV
• scheduled to receive anti-PD-1/-L1 ICI-containing therapy as standard of care treatment alone or in combination with co-treatments
Exclusion Criteria:

• identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• diagnosed with melanoma (because melanoma is very rare in AAs)
• received prior immunotherapy for cancer,
Conditions: Cancer
Keywords: Immune checkpoint inhibitor, Cancer, Disparities
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Treatment of Refractory Nausea

We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC057
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
Exclusion Criteria:

• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Chemotherapy, Nausea
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Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.

Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC068
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
Exclusion Criteria:

• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Conditions: Cancer
Keywords: Immunotherapy, Lung Cancer, Lung Cancer, Non Small cell lung cancer, NSCLC, Stage IV lung cancer
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Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

We are studying an internet-based pain coping skills program with pain education for cancer survivors who have persistent pain. Pain severity and interference will be compared to people who receive only pain education. The pain coping program has 8 sessions that are completed in the first 10 weeks of starting the study. The group that receives only pain education will receive access to the program after 6 months. Everyone is followed for 9 months

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC055
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of invasive cancer that has been treated with either single therapy or any combination of surgery, radiation, chemotherapy/drug therapy
• may be either off all treatment OR actively receiving anticancer therapy in an adjuvant (after surgery) setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive
• less than/equal to 5 years since the completion of their anticancer therapy
• experiencing continued pain
Exclusion Criteria:

• cancer history of only superficial skin cancers or in situ malignancy
• only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia)
• known or suspected diagnosable substance use disorder or opioid overuse disorder
• enrolled in hospice care or end-of-life palliative care
Conditions: Cancer
Keywords: Cancer Pain, Cancer Survivorship
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A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

We are studying how well radiation therapy with or without olaparib works in treating people with inflammatory breast cancer. Olaparib may keep cancer cells from repairing themselves, making them die. We want to see if adding this drug to radiation therapy is more effective.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC051
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of inflammatory breast cancer without distant metastases
• completed neoadjuvant chemotherapy prior to mastectomy
• radiation therapy has not been given to the affected breast
• able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication
Exclusion Criteria:

• active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
• history of uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or extensive interstitial bilateral lung disease
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Inflammatory Breast Cancer
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CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease (MRD)

We are enrolling people who have had complete surgical removal of a stage II or stage III colorectal cancer. We will draw blood samples for circulating tumor DNA (ctDNA) to find out if this blood test can be used to detect recurrence of the cancer. People will be followed for at least 3 years and up to 5 years.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC050
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of cancer of the colon or rectum (CRC)
• complete surgical resection, with last surgery occurring within 180 days prior to enrollment
Exclusion Criteria:

• started adjuvant (after surgery) therapy for current CRC diagnosis
• women who are pregnant or breastfeeding
• history of any invasive cancer except non-melanoma skin cancer
Conditions: Cancer
Keywords: Colon Cancer, Colon Cancer, Colorectal Cancer
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001256
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of acute pancreatitis no more than 90 days ago
Exclusion Criteria:

• definite diagnosis of chronic pancreatitis based on results of scans (study staff will review)
• pancreas tumors
• prior surgery on the pancreas
• pregnancy
• other significant health problems, study staff will review
Conditions: Diabetes & Endocrine, Digestive & Liver Health
Keywords: Diabetes, Pancreatitis, Pancreas
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors&#13;&#10;for Stroke Prevention and Recovery (ASPIRE)

This study will compare the effects of apixaban to aspirin in patients who have atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Principal Investigator: Oladi Bentho
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000694
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
Exclusion Criteria:

• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
• contact study staff for additional exclusion criteria
Conditions: Brain & Nervous System, Heart & Vascular
Keywords: aging, Anticoagulation, Atrial Fibrillation (AF), CVA, ICH, Intracerebral Hemorrhage, Stroke
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Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)

This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.

Principal Investigator: Rene Pierpont
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00016246
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Sex: Male
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
Exclusion Criteria:

• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Conditions: Brain & Nervous System, Children's Health, Rare Diseases
Keywords: Healthy control, children, pediatrics, adolescents
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