Contemporary Clinical Trials

Rationale and study protocol for a randomized controlled feeding study to determine the structural- and functional-level effects of diet-specific interventions on the gut microbiota of non-Hispanic black and white adults.  123. 2022

Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu combined ring study, 2019.  122. 2022

Design and outcome measures of LAVENDER, a phase 3 study of trofinetide for Rett syndrome.  114. 2022

Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team.  111. 2021

Effectiveness of a smoking cessation algorithm integrated into HIV primary care: Study protocol for a randomized controlled trial.  110. 2021

Effects of walking exercise training on learning and memory and hippocampal neuroimaging outcomes in MS: A targeted, pilot randomized controlled trial.  110. 2021

Study of emotional distress in a comparative effectiveness trial of diabetes treatments: Rationale and design.  107. 2021

The daily self-weighing for obesity management in primary care study: Rationale, design and methodology.  107. 2021

Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design.  105. 2021

Peer coach delivered storytelling program improved diabetes medication adherence: A cluster randomized trial.  104. 2021

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.  101. 2021

CITY Health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the Beat HIVe project.  99. 2020

Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.  98. 2020

Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.  97. 2020

Protocol for a systematically-developed, phase I/II, single-blind randomized controlled trial of treadmill walking exercise training effects on cognition and brain function in persons with multiple sclerosis.  87. 2019

Ticagrelor versus placebo for the reduction of vaso-occlusive crises in pediatric sickle cell disease: Rationale and design of a randomized, double-blind, parallel-group, multicenter phase 3 study (HESTIA3).  85. 2019

Effect of gamma aminobutyric acid (GABA) or GABA with glutamic acid decarboxylase (GAD) on the progression of type 1 diabetes mellitus in children: Trial design and methodology.  82:93-100. 2019

Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis.  81:110-122. 2019

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children.  78:20-26. 2019

In-home obesity prevention in low-income infants through maternal and social transmission.  77:61-69. 2019

A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial.  72:53-61. 2018

EMPIRE-CF: A phase II randomized placebo-controlled trial of once-daily, oral acebilustat in adult patients with cystic fibrosis – Study design and patient demographics.  72:86-94. 2018

Phase-III, randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis: Project BIPAMS.  71:154-161. 2018

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south.  71:186-193. 2018

Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol.  70:88-98. 2018

Assessing effects of behavioral intervention on treatment outcomes among patients initiating HIV care: Rationale and design of iENGAGE intervention trial.  69:48-54. 2018

Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty liver disease in adolescents with obesity: Trial design and methodology.  68:95-101. 2018

The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease.  67:23-30. 2018

Role of resistant starch on diabetes risk factors in people with prediabetes: Design, conduct, and baseline results of the STARCH trial.  65:99-108. 2018

Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.  53:162-170. 2017

Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department.  52:91-94. 2017

Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis.  50:166-177. 2016

Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors.  50:201-212. 2016

Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study.  50:106-115. 2016

The effects of urate lowering therapy on inflammation, endothelial function, and blood pressure (SURPHER) study design and rationale.  50:238-244. 2016

Evaluating a small change approach to preventing long term weight gain in overweight and obese adults - Study rationale, design, and methods.  47:275-281. 2016

Rationale, design, and baseline findings from HIPP: A randomized controlled trial testing a home-based, individually-tailored physical activity print intervention for African American women in the Deep South.  47:340-348. 2016

Embedding clinical interventions into observational studies.  46:100-105. 2016

Rationale, design, samples, and baseline sun protection in a randomized trial on a skin cancer prevention intervention in resort environments.  46:67-76. 2016

The feasibility and acceptability of a diet and exercise trial in overweight and obese black breast cancer survivors: The Stepping STONE study.  46:106-113. 2016

Using interactive Internet technology to promote physical activity in Latinas: Rationale, design, and baseline findings of Pasos Hacia La Salud.  44:149-158. 2016

Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.  45:177-183. 2015

Two-group time-to-event continual reassessment method using likelihood estimation.  45:340-345. 2015

A randomized controlled trial of outpatient CAncer REhabilitation for older adults: The CARE Program.  44:89-94. 2015

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.  44:164-174. 2015

Kaatsu training to enhance physical function of older adults with knee osteoarthritis: Design of a randomized controlled trial.  43:217-222. 2015

Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial.  43:237-242. 2015

Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.  42:90-97. 2015

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): Results of recruitment and baseline patient characteristics.  41:192-201. 2015

Effect of switching from intramuscular interferon β-1a to oral fingolimod on time to relapse in patients with relapsing-remitting multiple sclerosis enrolled in a 1-year extension of TRANSFORMS.  41:69-74. 2015

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.  37:272-283. 2014

Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial.  36:555-564. 2013

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): Design and methods.  35:77-86. 2013

Methodology of clinical research in rare diseases: Development of a research program in juvenile neuronal ceroid lipofuscinosis (JNCL) via creation of a patient registry and collaboration with patient advocates.  35:48-54. 2013

Reducing breast cancer recurrence with weight loss, a vanguard trial: The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial.  34:282-295. 2013

Design features of the diabetes and periodontal therapy trial (DPTT): A multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis.  36:515-526. 2013

The PAADRN Study: A design for a randomized controlled practical clinical trial to improve bone health.  34:90-100. 2013

Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States.  33:1211-1216. 2012

Rationale, design, and baseline findings from Seamos Saludables: A randomized controlled trial testing the efficacy of a culturally and linguistically adapted, computer- tailored physical activity intervention for Latinas.  33:1261-1271. 2012

The E-Coach transition support computer telephony implementation study: Protocol of a randomized trial.  33:1172-1179. 2012

Sample size re-estimation in an on-going NIH-sponsored clinical trial: The secondary prevention of small subcortical strokes experience.  33:1088-1093. 2012

Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: Rationale and design of the SLAM DUNC Study.  33:828-838. 2012

Retention of clinical trial participants in a study of Nongonococcal Urethritis (NGU), a sexually transmitted infection in men.  33:606-610. 2012

Recruitment of a rural, southern, predominantly African-American population into a diabetes self-management trial.  33:499-506. 2012

Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial.  33:184-196. 2012

Better exercise adherence after treatment for cancer (BEAT Cancer) study: Rationale, design, and methods.  33:124-137. 2012

Improving osteoporosis care in high-risk home health patients through a high-intensity intervention.  33:206-212. 2012

Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study.  33:55-59. 2012

Bayesian sample size determination under hypothesis tests.  32:393-398. 2011

Design of a randomized clinical trial to improve rates of amblyopia detection in preschool aged children in primary care settings.  32:204-214. 2011

International collaboration between US and Thailand on a clinical trial of treatment for HIV-associated cryptococcal meningitis.  31:34-43. 2010

Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations.  30:531-539. 2009

Enrollment of minorities in clinical trials: Did we overcome the barriers?.  30:103-104. 2009

A simulation based technique to estimate intracluster correlation for a binary variable.  30:71-80. 2009

Bayesian interim analysis in clinical trials.  29:751-755. 2008

A two stage conditional power adaptive design adjusting for treatment by covariate interaction.  29:428-438. 2008

Design of the supervised asthma therapy study: Implementing an adherence intervention in urban elementary schools.  29:304-310. 2008

Physical activity across the curriculum (PAAC): Rationale and design.  29:83-93. 2008

Investigators' assessment of NIH mandated inclusion of women and minorities in research.  27:571-579. 2006

Regulatory challenges: Lessons from recent West Nile virus trials in the United States.  27:254-259. 2006

Design and baseline characteristics of the osteoporotic fractures in men (MrOS) study - A large observational study of the determinants of fracture in older men.  26:569-585. 2005

Special populations recruitment for the Women's Health Initiative: Successes and limitations.  25:335-352. 2004

Medicine or Surgery (Ms): A randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding.  25:104-118. 2004

Negative results in cancer clinical trials - Equivalence or poor accrual?.  25:525-533. 2004

A randomized trial of colpopexy and urinary reduction efforts (CARE): Design and methods.  24:629-642. 2003

Leading the Way in Exercise and Diet (Project LEAD): Intervening to improve function among older breast and prostate cancer survivors.  24:206-223. 2003

Women's Angiographic Vitamin and Estrogen trial: Design and methods.  23:708-727. 2002

The Correction of Myopia Evaluation Trial (COMET): Design and general baseline characteristics.  22:573-592. 2001

Active: A cognitive intervention trial to promote independence in older adults.  22:453-479. 2001

Black participation in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial.  21:379s-389s. 2000

Recruitment strategies in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial: The first six years.  21:356s-378s. 2000

Recruitment strategies in the Women's Health Trial: Feasibility Study in Minority Populations.  19:461-476. 1998

Recruitment strategies in the women's health trial: feasibility study in minority populations. WHT:FSMP Investigators Group. Women's Health Trial:Feasibility Study in Minority Populations..  19:461-476. 1998

Statistical design of REACT (Rapid Early Action for Coronary Treatment), a multisite community trial with continual data collection.  19:391-403. 1998

Stroke Prevention Trial in Sickle Cell Anemia.  19:110-129. 1998

Trial of Calcium for Preeclampsia Prevention (CPEP): Rationale, design, and methods.  17:442-469. 1996

The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials.  16:408-421. 1995

Design of the Training Levels Comparison trial.  15:59-76. 1994

Patient perception of a long-term clinical trial: Experience using a close-out questionnaire in the studies of left ventricular dysfunction (SOLVD) trial.  15:284-293. 1994

Design of the Lung Health Study: A randomized clinical trial of early intervention for chronic obstructive pulmonary disease.  14:3-19. 1993

Distributed data analysis in a multicenter study: The CARDIA study.  13:80-90. 1992

Cardiovascular risk factors in young adults. The CARDIA baseline monograph..  12:1S-77S. 1991

Cardiovascular risk factors in young adults. The CARDIA baseline monograph.  12:1-77. 1991

Recruitment in the Coronary Artery Disease Risk Development in Young Adults (Cardia) study.  8:68-73. 1987

Correlates of attendance and compliance in the hypertension detection and follow-up program.  3:13-27. 1982

Validation of a risk function to predict mortality in a VA population with coronary artery disease.  3:47-60. 1982

Importance of stratification in later stages of clinical trials.  2:319-325. 1981

Application of survival analysis techniques to evaluation of factors affecting compliance in a clinical trial of hypertension control.  1:59-69. 1980

Where are they now? Successful strategies for retaining participants for over 25 years: The Coronary Artery Risk Development in Young Adults (CARDIA) Study