Clinical trials: completed, sponsored by 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
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
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
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
Diabetes Mellitus, Health Behavior
T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes
The primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus, Health Behavior, Diabetes Mellitus, Type 2, Group Meetings
- Trial name
- NCT06988540
- Testing
- Personalized Health Planning Program Administration, Usual Care
- Where
- United States
- Volunteers
- 92 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
Oxygen Toxicity
Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)
The purpose of this study is to understand how ketogenic food products affect oxygen toxicity in undersea divers. Oxygen toxicity affecting the central nervous system, mainly the brain, is a result of breathing higher than normal…
- Trial name
- NCT05801120
- Testing
- Ketogenic food products
- Where
- United States
- Volunteers
- 15 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
Bradycardia
Conduction System Pacing With INGEVITY+
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
- Trial name
- INSIGHT-LBBA (NCT06014866)
- Testing
- Cardiac pacing
- Where
- 8 sites in United States
- Volunteers
- 1,383 people
- Sponsor
- Duke University
Medication Therapy Management, Implementation Science
Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
This project aims to evaluate the scalability of an established, evidence-based, multi-component intervention, Senior PharmAssist^TM (SPA), designed to improve function and quality of life of older adults with limited incomes.
- Trial name
- NCT05278650
- Testing
- Senior PharmAssist^TM Program Implementation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Duke University
Instability, Joint, Shoulder Dislocation
Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
- Conditions
- Instability, Joint, Shoulder Dislocation, Shoulder Injuries, Shoulder Subluxation
- Trial name
- OREF (NCT05431114)
- Testing
- MRI
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Duke University
Cognition Disorder, Stroke
NeuroCognition After Carotid Recanalization
Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution.
- Conditions
- Cognition Disorder, Stroke, Occlusion Carotid
- Trial name
- NIA-SCORE (NCT04219774)
- Testing
- Endovascular intervention, Aspirin and Clopidogrel (maximal medical Therapy)
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Duke University
Lung Cancer Metastatic
DBT for Metastatic Lung Cancer
Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers.
- Trial name
- LiveWell (NCT04973436)
- Testing
- Dialectical Behavioral Therapy Skills Training
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Duke University
Suicide, Suicidal Ideation
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
The overall objectives of the proposed research are to develop a brief telehealth counseling intervention to provide support for people living with HIV and experiencing suicidal ideation, and to support HIV care engagement.
- Conditions
- Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication
- Trial name
- NCT04696861
- Testing
- IDEAS for Hope, Enhanced Standard of Care (Safety Planning)
- Where
- 2 sites in Tanzania
- Volunteers
- 60 people
- Sponsor
- Duke University
Obesity, Overweight
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical practice guidelines clearly recommend that these patients avoid gaining weight.
- Conditions
- Obesity, Overweight, Overnutrition, Nutrition Disorders
- Trial name
- D0479 (NCT03003403)
- Testing
- Intervention Program
- Where
- United States
- Volunteers
- 443 people, healthy volunteers welcome
- Sponsor
- Duke University
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