Contemporary Clinical Trials

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

Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial.  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

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

Results of a feasibility study of a patient informed, racially tailored home-based exercise program for black persons with multiple sclerosis.  75:1-8. 2018

Home-based, square-stepping exercise program among older adults with multiple sclerosis: results of a feasibility randomized controlled study.  73:136-144. 2018

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

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

Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.  61:39-47. 2017

Results of a feasibility randomised controlled study of the guidelines for exercise in multiple sclerosis project.  54:84-97. 2017

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

Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis.  47:32-39. 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

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

Experimental protocol of a randomized controlled clinical trial investigating exercise, subclinical atherosclerosis, and walking mobility in persons with multiple sclerosis.  41:280-286. 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

Rationale and design of a randomized controlled, clinical trial investigating a comprehensive exercise stimulus for improving mobility disability outcomes in persons with multiple sclerosis.  35:151-158. 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

Rationale and design of a clinical trial investigating resistance training as an aid to smoking cessation in persons with multiple sclerosis.  33:848-852. 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

Physical activity, function, and quality of life: Design and methods of the FlexToBa ^TM trial.  33:228-236. 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

The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial.  32:260-266. 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

Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience.  28:720-729. 2007

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

Black participation in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial..  21. 2000

Recruitment strategies in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: the first six years..  21. 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