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Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis.
A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial.
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.
Phase-III, randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis: Project BIPAMS.
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.
Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol.
Assessing effects of behavioral intervention on treatment outcomes among patients initiating HIV care: Rationale and design of iENGAGE intervention trial.
Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty liver disease in adolescents with obesity: Trial design and methodology.
Role of resistant starch on diabetes risk factors in people with prediabetes: Design, conduct, and baseline results of the STARCH trial.
Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.
Results of a feasibility randomised controlled study of the guidelines for exercise in multiple sclerosis project.
Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.
Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department.
Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis.
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.
Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study.
The effects of urate lowering therapy on inflammation, endothelial function, and blood pressure (SURPHER) study design and rationale.
Evaluating a small change approach to preventing long term weight gain in overweight and obese adults - Study rationale, design, and methods.
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.
Embedding clinical interventions into observational studies.
Rationale, design, samples, and baseline sun protection in a randomized trial on a skin cancer prevention intervention in resort environments.
The feasibility and acceptability of a diet and exercise trial in overweight and obese black breast cancer survivors: The Stepping STONE study.
Using interactive Internet technology to promote physical activity in Latinas: Rationale, design, and baseline findings of Pasos Hacia La Salud.
Two-group time-to-event continual reassessment method using likelihood estimation.
A randomized controlled trial of outpatient CAncer REhabilitation for older adults: The CARE Program.
Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.
Kaatsu training to enhance physical function of older adults with knee osteoarthritis: Design of a randomized controlled trial.
Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial.
Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.
Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): Results of recruitment and baseline patient characteristics.
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.
The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.
Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial.
Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): Design and methods.
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.
Rationale and design of a randomized controlled, clinical trial investigating a comprehensive exercise stimulus for improving mobility disability outcomes in persons with multiple sclerosis.
Reducing breast cancer recurrence with weight loss, a vanguard trial: The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial.
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.
The PAADRN Study: A design for a randomized controlled practical clinical trial to improve bone health.
Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States.
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.
The E-Coach transition support computer telephony implementation study: Protocol of a randomized trial.
Sample size re-estimation in an on-going NIH-sponsored clinical trial: The secondary prevention of small subcortical strokes experience.
Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: Rationale and design of the SLAM DUNC Study.
Retention of clinical trial participants in a study of Nongonococcal Urethritis (NGU), a sexually transmitted infection in men.
Recruitment of a rural, southern, predominantly African-American population into a diabetes self-management trial.
Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial.
Better exercise adherence after treatment for cancer (BEAT Cancer) study: Rationale, design, and methods.
Improving osteoporosis care in high-risk home health patients through a high-intensity intervention.
Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study.
Bayesian sample size determination under hypothesis tests.
Design of a randomized clinical trial to improve rates of amblyopia detection in preschool aged children in primary care settings.
The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial.
International collaboration between US and Thailand on a clinical trial of treatment for HIV-associated cryptococcal meningitis.
Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations.
Enrollment of minorities in clinical trials: Did we overcome the barriers?.
A simulation based technique to estimate intracluster correlation for a binary variable.
Bayesian interim analysis in clinical trials.
A two stage conditional power adaptive design adjusting for treatment by covariate interaction.
Design of the supervised asthma therapy study: Implementing an adherence intervention in urban elementary schools.
Physical activity across the curriculum (PAAC): Rationale and design.
Diagnostic criteria and adjudication process both determine published event-rates: The ACTION trial experience.
Investigators' assessment of NIH mandated inclusion of women and minorities in research.
Regulatory challenges: Lessons from recent West Nile virus trials in the United States.
Design and baseline characteristics of the osteoporotic fractures in men (MrOS) study - A large observational study of the determinants of fracture in older men.
Special populations recruitment for the Women's Health Initiative: Successes and limitations.
Medicine or Surgery (Ms): A randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding.
Negative results in cancer clinical trials - Equivalence or poor accrual?.
A randomized trial of colpopexy and urinary reduction efforts (CARE): Design and methods.
Leading the Way in Exercise and Diet (Project LEAD): Intervening to improve function among older breast and prostate cancer survivors.
Women's Angiographic Vitamin and Estrogen trial: Design and methods.
The Correction of Myopia Evaluation Trial (COMET): Design and general baseline characteristics.
Active: A cognitive intervention trial to promote independence in older adults.
Black participation in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial.
Recruitment strategies in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial: The first six years.
Black participation in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial..
Recruitment strategies in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: the first six years..
Recruitment strategies in the Women's Health Trial: Feasibility Study in Minority Populations.
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..
Statistical design of REACT (Rapid Early Action for Coronary Treatment), a multisite community trial with continual data collection.
Stroke Prevention Trial in Sickle Cell Anemia.
Trial of Calcium for Preeclampsia Prevention (CPEP): Rationale, design, and methods.
The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials.
Design of the Training Levels Comparison trial.
Patient perception of a long-term clinical trial: Experience using a close-out questionnaire in the studies of left ventricular dysfunction (SOLVD) trial.
Design of the Lung Health Study: A randomized clinical trial of early intervention for chronic obstructive pulmonary disease.
Distributed data analysis in a multicenter study: The CARDIA study.
Cardiovascular risk factors in young adults. The CARDIA baseline monograph..
Cardiovascular risk factors in young adults. The CARDIA baseline monograph.
Recruitment in the Coronary Artery Disease Risk Development in Young Adults (Cardia) study.
Correlates of attendance and compliance in the hypertension detection and follow-up program.
Validation of a risk function to predict mortality in a VA population with coronary artery disease.
Importance of stratification in later stages of clinical trials.
Application of survival analysis techniques to evaluation of factors affecting compliance in a clinical trial of hypertension control.