Clinical trials: sponsored by Duke University
Colon Cancer
Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
This is a research study to test whether two immunotherapy drugs-cemiplimab and fianlimab-can safely and effectively shrink colon tumors before surgery in people with stage II-III colon cancer that has not spread to other parts…
- Trial name
- NACho (NCT07224022)
- Testing
- Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
- Volunteers
- 24 people
- Sponsor
- John Strickler, M.D.
Long COVID, Long Covid19
RECOVER-ENERGIZE Platform Protocol
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management…
- Conditions
- Long COVID, Long Covid19, Long Covid-19
- Trial name
- NCT06404047
- Testing
- Personalized Cardiopulmonary Rehabilitation, Structured Pacing, Education
- Where
- 42 sites in United States
- Volunteers
- 660 people
- Sponsor
- Duke University
Isolated Cervical Dystonia
Accelerating TMS for Cervical Dystonia
This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia.
- Trial name
- NCT06328114
- Testing
- Transcranial Magnetic Stimulation (TMS), trihexyphenidyl 10mg
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Duke University
Glaucoma
Tolerability of an Anesthesia-free Tonometer Tip
The purpose of this study is to compare the tolerability and comfort of 4 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia.
- Trial name
- NCT06585423
- Testing
- Sterile commercially available bandage contact lens, Medical grade silicone of a thickness <100 µm, Medical grade silicone of a thickness >100 µm
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Duke University
Non-small Cell Lung Cancer (NSCLC)
PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung
PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can…
- Trial name
- NCT05553834
- Testing
- Alirocumab and Cemiplimab
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Prostate Cancer (Diagnosis)
Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer
This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease.
- Trial name
- NCT07144228
- Testing
- HeLP TM
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Duke University
Esophageal Adenocarcinoma
Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma
The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.
- Trial name
- TNT Esophagus (NCT07603375)
- Testing
- FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Lumbar Spine Degeneration, Lumbar Spine Instability
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.
- Conditions
- Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis
- Trial name
- NOTICE (NCT04140344)
- Testing
- Text Message Group
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Duke University
Corneal Diseases, Retinal Diseases
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
The study team will conduct the first in-human pilot studies using 4D MIOCT for imaging in the operating room. Building on the earlier integration and wet-lab validations, the researchers will assess the system's ease of use…
- Conditions
- Corneal Diseases, Retinal Diseases, Ocular Diseases
- Trial name
- 4D MIOCT (NCT07024719)
- Testing
- 4D MIOCT integrated into a Zeiss Artevo 800
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Duke University
Alcohol Use Disorder, Injury Traumatic
PRACT to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department BIs in Tanzania
Alcohol use is rapidly increasing in low- and middle-income countries, where it is inexpensive, readily available, poorly regulated, and there are few resources devoted to promoting safe alcohol use.
- Conditions
- Alcohol Use Disorder, Injury Traumatic, Trauma
- Trial name
- PRACT (NCT04535011)
- Testing
- PPKAY (brief intervention), Standard Booster, Personalized Booster
- Where
- Tanzania
- Volunteers
- 673 people
- Sponsor
- Duke University
Krabbe Disease
Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients
This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101.
- Trial name
- NCT06308718
- Testing
- FBX-101
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Duke University
Krabbe Disease
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT
This is a non-blinded, non-randomized dose escalation study of intravenous FBX-101 in which subjects will receive a single infusion of an adeno-associated virus gene therapy product, after more than 21 days of the HSCT (UCBT…
- Trial name
- REKLAIM (NCT05739643)
- Testing
- FBX-101
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Duke University
Traumatic Brain Injury
BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Despite poor outcomes for adults with traumatic brain injury (TBI), there are no U.S. standards for TBI transitional care for patients discharged home from acute hospital care.
- Trial name
- NCT05929833
- Testing
- BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), Usual Care
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Duke University
Aneurysmal Subarachnoid Hemorrhage
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
An exploratory, randomized, double-blinded, placebo-controlled, two-center clinical trial to determine the maximum tolerated dosage of intravenous tirofiban in patients with aneurysmal subarachnoid hemorrhage (aSAH)…
- Trial name
- iSPASM-2 (NCT07493577)
- Testing
- Tirofiban
- Where
- 2 sites in United States
- Volunteers
- 82 people
- Sponsor
- Dr David Hasan, M.D.
Amyotrophic Lateral Sclerosis ALS
Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
This is an open label trial of a supplement called HMB in patients with ALS. The researchers are evaluating its safety and tolerability, as well as its ability to lower insulin-like growth-factor binding protein 7 (IGFBP7) and…
- Trial name
- ROAR HMB (NCT07589764)
- Testing
- β-hydroxy-β-methylbutyrate (HMB)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Duke University
Breast Cancer
Radiation Therapy and Thymus Function in Young Women With Breast Cancer
Breast cancer treatment sometimes includes radiation to the breast or chest wall. There is a small gland, called the thymus, located in the upper chest that may receive a small amount of the radiation aimed at the breast.
- Trial name
- NCT07725172
- Testing
- Blood draw for the laboratory assessment
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Duke University
Stigma, HIV
Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being
The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against…
- Conditions
- Stigma, HIV, Well-Being, Psychological
- Trial name
- NCT05785169
- Testing
- All-facility Training
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Columbia University
Glaucoma, Glaucoma, Suspect
Automated Applanation Tonometry - Updated
Goldmann Applanation Tonometry (GAT) is considered the clinical gold standard for eye pressure measurements and yet it is known to be a subjective measurement with limited repeatability and limited portability.
- Trial name
- NCT07298356
- Testing
- Standard GAT, Fixed force GAT, Upright applanating prototype
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Duke University
Atopic Dermatitis
Dupilumab De-escalation in Pediatric Atopic Dermatitis
This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD)…
- Trial name
- NCT06116526
- Testing
- Dupilumab - Discontinuation, Dupilumab - Dose Reduction, Dupilumab - Standard Dose
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Johns Hopkins University
Chronic Obstructive Pulmonary Disease (COPD)
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
The purpose of this study is to investigate the safety and tolerability of Metformin and how it changes blood markers associated with aging in persons who have chronic obstructive pulmonary disease (COPD) who do not have diabetes.
- Trial name
- INSPIRE-COPD-E (NCT07275359)
- Testing
- Metformin
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Duke University