Clinical trials: sponsored by Duke University
Pregnancy
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated…
- Trial name
- Tdap/IIV (NCT02783170)
- Testing
- Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine, 2017-2018 Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 81 people
- Sponsor
- Duke University
Palliative Care, Critical Illness
A Needs-focused Palliative Care Intervention for Older Adults in ICUs
The quality of intensive care unit (ICU)-based palliative care is highly variable, particularly for the 2 million older adults admitted annually to ICUs.
- Conditions
- Palliative Care, Critical Illness, Aging, Care Delivery Model
- Trial name
- PCplanner (NCT04414787)
- Testing
- PCplanner
- Where
- United States
- Volunteers
- 151 people
- Sponsor
- Duke University
Long COVID, Long COVID-19
RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs…
- Conditions
- Long COVID, Long COVID-19, Long COVID19
- Trial name
- NCT05965752
- Testing
- BrainHQ/Active Comparator Activity, BrainHQ, PASC CoRE
- Where
- 24 sites in United States
- Volunteers
- 328 people
- Sponsor
- Duke University
Urinary Bladder, Underactive
Amplifying Sensation in Underactive Bladder
The purpose of this study is to determine the influence of intravesical (bladder) electrical stimulation and intraurethral electrical stimulation on bothersome symptoms and bladder function in neurologically-intact adult women…
- Trial name
- AMPLIFY (NCT04516434)
- Testing
- Neurometer Neurotron CPT, Cystometry, Pressure-flow study
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Duke University
Functional Abdominal Pain
Feeling and Body Investigators for Pediatric Abdominal Pain
This study will provide tools to develop and pilot an intervention for Functional Abdominal Pain (FAP) using a ten session intervention with children ages 5-8.
- Trial name
- FBI (NCT02075437)
- Testing
- Feeling and Body Investigators with Functional Abdominal Pain, Treatment Strategies
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Emotional Distress, Anxiety
Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility
Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health and is associated with a reduction in daily activity.
- Conditions
- Emotional Distress, Anxiety, Depression
- Trial name
- NCT04837521
- Testing
- Unified Protocol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Duke University
COPD, Anxiety
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
Objective: Determine whether treatment of perceived stress, anxiety, and depression with anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of life (QoL) in patients with Chronic Obstructive…
- Conditions
- COPD, Anxiety, Depression, Stress
- Trial name
- SAD-COPD (NCT02813447)
- Testing
- Sertraline
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Duke University
Depression
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design.
- Trial name
- ADOPT PGx (NCT05966155)
- Testing
- Pharmacogenetic testing, Clinical decisions support
- Where
- 14 sites in United States
- Volunteers
- 1,572 people
- Sponsor
- Duke University
Cancer, Young Adult
Symptom Management for YA Cancer Survivors
Symptom interference is common for survivors of young adult cancer (aged 18-39 at diagnosis) and impacts their abilities to achieve normative life goals (e.g., education, careers, independence, romantic/social relationships) as…
- Conditions
- Cancer, Young Adult, Pain, Psychological Distress
- Trial name
- NCT04035447
- Testing
- Behavioral Symptom Management for Young Adult Cancer Survivors
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Duke University
Low Back Pain, Veterans Family
Improving Veteran Access to Integrated Management of Back Pain
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care…
- Trial name
- AIM-BACK (NCT04411420)
- Testing
- Pain modulation with physical pain treatment, Telephone delivered self-management counseling for increasing physical activity, Telephone delivered behavioral treatment for participants with high risk for continued disability
- Where
- United States
- Volunteers
- 1,817 people
- Sponsor
- Duke University
Weight Loss Maintenance
Enhancing Physical Function in the Long-term for Older Adults
The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults…
- Trial name
- NCT04490356
- Testing
- Legacy Intervention
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Duke University
Cervical Cancer, HPV Infection
1:1 Comparison of the Pocket Colposcope in Kenya
The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date.
- Conditions
- Cervical Cancer, HPV Infection, HIV Infections
- Trial name
- NCT04998318
- Testing
- Pocket Colposcope, Standard of Care Colposcopy
- Where
- Kenya
- Volunteers
- 434 people
- Sponsor
- Duke University
Chronic Kidney Disease, Hypertension
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States Pharmacogenetic Substudy
This is a substudy of GUARDD-US (Genetic testing to Understand and Address Renal Disease Disparities across the United States, NCT04191824).
- Trial name
- GUARDD-US PGx (NCT06748040)
- Testing
- Timing of return of results
- Where
- 8 sites in United States
- Volunteers
- 1,874 people
- Sponsor
- Duke University
Cardiac Rehabilitation, Health Coaching
Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation
To identify factors and triggers influencing physical activity (PA) participation after structured cardiac rehabilitation (CR) among older adults who have enrolled in a center-based CR program, and compare the effects of a…
- Conditions
- Cardiac Rehabilitation, Health Coaching, Physical Activity
- Trial name
- Target-CR (NCT05773287)
- Testing
- Targeted Health Coaching Group, Standard Care Group
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Duke University
Influenza, COVID-19
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.
- Trial name
- NCT06020118
- Testing
- Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster), Sequential Vaccination (Influenza vaccine then mRNA COVID booster), Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
- Where
- 8 sites in United States
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Infections, Adolescent Behavior
Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
The overall goal of this pilot randomized-controlled trial (RCT) is to pilot MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health"), an ART adherence-supporting smartphone app with 50…
- Trial name
- NCT04661878
- Testing
- Social Support, Informational Resources, Self-Monitoring and habit formation
- Where
- South Africa
- Volunteers
- 50 people
- Sponsor
- Duke University
Blood Pressure
Postpartum ASA and NT-proBNP
This study is a double-blinded randomized-controlled trial in which patients will be randomized to 81 mg of aspirin or placebo to be continued for 6 weeks' postpartum.
- Trial name
- NCT05889468
- Testing
- Aspirin 81Mg Ec Tab
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Duke University
Hyperkalemia, End Stage Renal Disease
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD).
- Trial name
- NCT03781089
- Testing
- Patiromer Oral Powder Product
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Duke University
HIV, Stigma, Social
Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania
This study will test a stigma reduction intervention with women living with HIV in Tanzania.
- Conditions
- HIV, Stigma, Social, Self Efficacy, Self Esteem
- Trial name
- NCT05033002
- Testing
- Labda Siku Moja stigma reduction intervention
- Where
- Tanzania
- Volunteers
- 167 people
- Sponsor
- Duke University
Chronic Pain
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design.
- Trial name
- ADOPT PGx (NCT05966142)
- Testing
- Pharmacogenetic testing, Clinical decisions support
- Where
- 10 sites in United States
- Volunteers
- 1,048 people
- Sponsor
- Duke University