Clinical trials: sponsored by Duke University
Mild Cognitive Impairment, Obesity
Time Restricted Eating for Metabolic and Psychological Optimization
Obesity and related metabolic comorbidities have been associated with more than a 4-fold increased risk of incident cognitive impairment, including Alzheimer's disease and related dementias (ADRD).
- Trial name
- TEMPO (NCT05997316)
- Testing
- Time restricted eating
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of North Carolina, Chapel Hill
Autism, Autism Spectrum Disorder
hCT-MSC in Children With Autism Spectrum Disorder
The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder…
- Trial name
- IMPACT (NCT04089579)
- Testing
- Cord Tissue Mesenchymal Stromal Cells
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Joanne Kurtzberg, MD
Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled.
- Conditions
- Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
- Trial name
- BRIDGET (NCT05323955)
- Testing
- Trastuzumab, Trastuzumab Emtansine (T-DM1), Pertuzumab
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carey Anders, M.D.
Stroke, Mental Health Wellness 1
Emotional Recovery Post-Stroke
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation…
- Trial name
- eWELL (NCT06782321)
- Testing
- modified Cognitive Behavioral Therapy (mCBT), Occupational or Speech Therapy
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medical University of South Carolina
Neurological Disorder, Autoimmune Diseases
Disease-Modifying Treatments for Myasthenia Gravis
This study is designed to address the evidence gaps in a real-world setting and help patients with MG choose treatments that are best suited to them.
- Trial name
- PROMISE-MG (NCT03490539)
- Testing
- Mycophenolate Mofetil, Azathioprine
- Where
- 19 sites in United States, Canada
- Volunteers
- 82 people
- Sponsor
- Duke University
Sickle Cell Disease, Sickle Cell Anemia
Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
The purpose of this research study is to document and understand the effects of hydroxyurea exposure for women with SCD and their babies, during both gestation and lactation.
- Trial name
- HELPFUL (NCT04093986)
- Testing
- Chart Review, Survey
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma.
- Conditions
- Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood, Malignant Glioma
- Trial name
- PRiME (NCT03299309)
- Testing
- PEP-CMV
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Daniel Landi
Acute Pain, Postoperative Pain, Acute
REctus Sheath Trial
Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the abdominal wall. The most established technique is thoracic epidural.
- Trial name
- REST (NCT07068243)
- Testing
- 1.0% lidocaine with epinephrine (1:100,000)
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Duke University
Overactive Bladder, Overactive Bladder Syndrome
Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS).
- Trial name
- POSITRON-C (NCT06769854)
- Testing
- Urgent PC
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chi Dang Hornik
Breast Cancer, Triple Negative Breast Cancer
Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer
This research study is looking to see whether the combination of Dostarlimab and Niraparib plus Radiation Therapy (RT) is safe and effective in participants with metastatic triple negative breast cancer.
- Trial name
- NADiR (NCT04837209)
- Testing
- Niraparib, Dostarlimab, Radiation therapy
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Massachusetts General Hospital
Cardiorespiratory Fitness
Calibre vs. COSMED
This study evaluates agreement between the Calibre device and the COSMED Quark CPET system for measurement of cardiorespiratory fitness parameters during maximal exercise testing in adults aged 18-55 years.
- Trial name
- NCT07596108
- Testing
- COSMED Quark CPET metabolic cart, Calibre Biometrics
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Duke University
Healthy Volunteers, Sympathetic Activity
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
The SPARK Study evaluates changes in peripheral sympathetic vasomotor activity following a targeted, ultrasound-guided periarterial sympathetic block of the distal radial artery in healthy volunteers.
- Trial name
- SPARK (NCT07429292)
- Testing
- Lidocaine 2%
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Duke University
Acute Respiratory Distress Syndrome
Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)
This study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS.
- Trial name
- NCT03799874
- Testing
- Inhaled Carbon Monoxide at 200 ppm, Inhaled Medical air
- Where
- 7 sites in United States
- Volunteers
- 4 people
- Sponsor
- Brigham and Women's Hospital
Retinitis Pigmentosa
Oral N-acetylcysteine for Retinitis Pigmentosa
Retinitis pigmentosa (RP) is an inherited retinal degeneration caused by one of several mistakes in the genetic code. Such mistakes are called mutations.
- Trial name
- NAC Attack (NCT05537220)
- Testing
- N-acetylcysteine
- Where
- 31 sites in United States, Austria and 5 more
- Volunteers
- 485 people
- Sponsor
- Johns Hopkins University
Spontaneous Intracranial Hypotension
CVFs in SIH: EID vs. PCD CTM
The purpose of this research study is to compare two types of Computed Tomography Myelography (CTM) scans, one on the photon counting detector scanner (called PCD-CTM) and the other on the energy integrating detector scanner…
- Trial name
- NCT07582744
- Testing
- photon counting detector CT myelography (PCD- CTM), energy integrating detector CT myelography (EID-CTM)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Duke University
Environmental and Genetic Factors on Lung Function
ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return…
- Trial name
- NCT03599206
- Testing
- Ozone, Filtered Air
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Robert Tighe, MD
Healthy
Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Healthy Study participants will undergo a 1-day screening that includes a blood draw and breathing testing…
- Trial name
- MOZEPH (NCT03646877)
- Testing
- Ozone, Filtered Air
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Robert Tighe, MD
Alzheimer Disease, Smell Loss
Olfactory Biopsies
This research study aims to investigate the function of the olfactory lining in the nasal cavity and its potential alterations in both healthy and diseased conditions. The olfactory lining is involved in the sense of smell.
- Conditions
- Alzheimer Disease, Smell Loss, Smell Dysfunction
- Trial name
- NCT07021040
- Testing
- olfactory testing, Odor stimulation, Olfactory biopsy
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Duke University
Dry Eye, Graft-versus-host-disease
Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease
The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye…
- Conditions
- Dry Eye, Graft-versus-host-disease, Ocular Discomfort
- Trial name
- NCT03414645
- Testing
- CAM-101 10%, Vehicle Control, CAM-101 30%
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Cambium Bio Limited
Oropharynx Cancer
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a…
- Trial name
- NCT04667585
- Testing
- De-escalated radiation dose, Standard radiation dose, 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Duke University
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