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Publication Venue For
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Equity and bias in electronic health records data..
107238.
2023
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A framework for setting enrollment goals to ensure participant diversity in sponsored clinical trials in the United States..
129:107184.
2023
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A phase 2, adaptive randomized, double-blind, placebo-controlled, multicenter, 52-week study of HM15211 in patients with biopsy-confirmed non-alcoholic steatohepatitis - Study design and rationale of HM-TRIA-201 study..
130:107176.
2023
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Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity..
126:107105.
2023
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Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience..
125:107067.
2023
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Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial..
125:107060.
2023
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The Greenlight Plus Trial: Comparative effectiveness of a health information technology intervention vs. health communication intervention in primary care offices to prevent childhood obesity..
123:106987.
2022
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The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial..
123:106978.
2022
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Economic analysis of a single institutional review board data exchange standard in multisite clinical studies..
122:106953.
2022
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Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial..
122:106934.
2022
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A multicenter program for electronic health record screening for patients with heart failure with preserved ejection fraction: Lessons from the DELIVER-EHR initiative..
121:106924.
2022
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Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study..
120:106861.
2022
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Contingency management and cognitive behavior therapy for smoking cessation among veterans with posttraumatic stress disorder: Design and methodology of a randomized clinical trial..
119:106839.
2022
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Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension..
119:106813.
2022
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Preface to theme issue on pragmatic and virtual trials: Progress and challenges..
119:106816.
2022
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Beyond privacy: A deeper understanding of the internet is required to protect digitized trial participants..
118:106786.
2022
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Iterative approaches to the use of electronic health records data for large pragmatic studies..
117:106789.
2022
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Inclusion and diversity in clinical trials: Actionable steps to drive lasting change..
116:106740.
2022
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COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic..
115:106709.
2022
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Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials..
115:106703.
2022
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The challenges of data safety monitoring for a pragmatic study: Lessons from the ADAPTABLE study..
115:106732.
2022
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Two weights make a wrong: Cluster randomized trials with variable cluster sizes and heterogeneous treatment effects..
114:106702.
2022
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Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials..
113:106646.
2022
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Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem..
113:106651.
2022
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Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder: Telemedicine for Evaluation, Adherence and Medication for Hepatitis C (TEAM-C)..
112:106632.
2022
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Protocol for the models of primary osteoporosis screening in men (MOPS) cluster randomized trial..
112:106634.
2022
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Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial..
111:106602.
2021
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A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms..
110:106569.
2021
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A reanalysis of pain crises data from the pivotal l-glutamine in sickle cell disease trial..
110:106546.
2021
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STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations..
110:106583.
2021
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Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform..
109:106525.
2021
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Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016..
109:106540.
2021
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Rationale and design of the Prone Position and Respiratory Outcomes in Non-intubated COVID-19 PatiEnts: The "PRONE" Study..
109:106541.
2021
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The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension..
109:106539.
2021
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The use of real-world data/evidence in regulatory submissions..
109:106521.
2021
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Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France..
107:106465.
2021
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The Head and Neck Survivorship Tool (HN-STAR) Trial (WF-1805CD): A protocol for a cluster-randomized, hybrid effectiveness-implementation, pragmatic trial to improve the follow-up care of head and neck cancer survivors..
107:106448.
2021
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Corrigendum to "Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: Race as an example" [Contemporary Clinical Trials volume 88 (2020) 105775]..
103:106298.
2021
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Improving racial disparities in unmet palliative care needs among intensive care unit family members with a needs-targeted app intervention: The ICUconnect randomized clinical trial..
103:106319.
2021
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Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial..
102:106287.
2021
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The effect of reducing posttraumatic stress disorder symptoms on cardiovascular risk: Design and methodology of a randomized clinical trial..
102:106269.
2021
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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..
101:106246.
2021
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Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy..
101:106245.
2021
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Trial design of comparing patient-specific versus weight-based protocols to treat vaso-occlusive episodes in sickle cell disease (COMPARE-VOE)..
101:106252.
2021
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Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial..
99:106186.
2020
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Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial..
98:106163.
2020
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Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial..
98:106157.
2020
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Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B)..
98:106103.
2020
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Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial..
96:106119.
2020
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Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss..
96:106092.
2020
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A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment..
95:106066.
2020
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Clinical trial testing in-home multidisciplinary care management for older adults with cognitive vulnerability: Rationale and study design..
92:105992.
2020
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Improving health engagement and lifestyle management for breast cancer survivors with diabetes..
92:105998.
2020
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Communicating health information and improving coordination with primary care (CHIIP): Rationale and design of a randomized cardiovascular health promotion trial for adult survivors of childhood cancer..
89:105915.
2020
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Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: Race as an example..
88:105775.
2020
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Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial..
84:105826.
2019
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Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial)..
82:66-76.
2019
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Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial..
81:11-18.
2019
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Vitamin D supplementation for prevention of cancer: The D2d cancer outcomes (D2dCA) study..
81:62-70.
2019
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Corrigendum to "Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD" [Contemp. Clin. Trials 41 (2015) 75-84]..
80:61.
2019
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Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods..
78:27-33.
2019
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Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era..
77:98-103.
2019
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Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET)..
76:120-131.
2019
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The LURN Research Network Neuroimaging and Sensory Testing (NIST) Study: Design, protocols, and operations..
74:76-87.
2018
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Design of a clinical effectiveness trial of in-home cognitive processing therapy for combat-related PTSD..
73:27-35.
2018
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Putting patients at the center of kidney care transitions: PREPARE NOW, a cluster randomized controlled trial..
73:98-110.
2018
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Intensive prolonged exposure therapy for combat-related posttraumatic stress disorder: Design and methodology of a randomized clinical trial..
72:126-136.
2018
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The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial..
72:73-85.
2018
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Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial)..
71:88-95.
2018
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Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial..
69:28-39.
2018
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Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation..
68:1-6.
2018
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Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial..
68:116-126.
2018
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Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial..
67:91-99.
2018
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Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis..
67:100-108.
2018
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Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity..
65:116-122.
2018
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Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial..
64:118-127.
2018
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The Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin in Sleep Apnoea- rationale and methodology of the SNORE-ASA study..
64:101-111.
2018
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A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial..
60:42-50.
2017
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Family-based obesity prevention for infants: Design of the "Mothers & Others" randomized trial..
60:24-33.
2017
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Building research in diet and cognition: The BRIDGE randomized controlled trial..
59:87-97.
2017
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Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial..
58:1-12.
2017
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Physiological and psychological effects of testosterone during severe energy deficit and recovery: A study protocol for a randomized, placebo-controlled trial for Optimizing Performance for Soldiers (OPS)..
58:47-57.
2017
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Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART..
57:51-57.
2017
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Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment..
57:58-68.
2017
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Rationale and study protocol for the Patient-Centered Outcome Aid (PCOA) randomized controlled trial: A personalized decision tool for newly diagnosed ovarian cancer patients..
57:29-36.
2017
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Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial..
56:9-17.
2017
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A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial..
55:1-9.
2017
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Applying self-determination theory to the blood donation context: The blood donor competence, autonomy, and relatedness enhancement (Blood Donor CARE) trial..
53:44-51.
2017
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Protocol of the KTFT-TALK study to reduce racial disparities in kidney transplant evaluation and living donor kidney transplantation..
53:52-59.
2017
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Corrigendum to "Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool" [Contemporary Clinical Trials. 2016 Jul. 19; 50: 90-97]..
51:98.
2016
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Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression..
51:65-71.
2016
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Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention..
50:157-165.
2016
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Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool..
50:90-97.
2016
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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
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Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics..
50:5-15.
2016
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Brief treatment for PTSD: A non-inferiority trial..
48:76-82.
2016
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Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients..
48:12-20.
2016
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Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study..
47:158-164.
2016
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Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience..
47:376-382.
2016
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Embedding clinical interventions into observational studies..
46:100-105.
2016
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Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study..
46:30-38.
2016
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Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods..
44:164-174.
2015
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Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview..
44:64-69.
2015
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Sample size calculations for the design of cluster randomized trials: A summary of methodology..
42:41-50.
2015
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Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD..
41:75-84.
2015
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Self-Care for Older People (SCOPE): a cluster randomized controlled trial of self-care training and health outcomes in low-income elderly in Singapore..
41:313-324.
2015
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Design and implementation of a study evaluating extinction processes to food cues in obese children: the Intervention for Regulations of Cues Trial (iROC)..
40:95-104.
2015
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Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial..
40:112-123.
2015
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The keys to healthy family child care homes intervention: study design and rationale..
40:81-89.
2015
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Corrigendum to "Weight loss intervention for young adults using mobile technology: Design and rationale of a randomized controlled trial - Cell phone Intervention for You (CITY)" [Contemp Clin Trials 37/2 (2014) 333-341]..
39:351.
2014
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Discharge information and support for veterans Receiving Outpatient Care in the Emergency Department: study design and methods..
39:342-350.
2014
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A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence..
39:106-112.
2014
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Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: the Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study..
39:95-105.
2014
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A randomized trial of diet in men with early stage prostate cancer on active surveillance: rationale and design of the Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance])..
38:198-203.
2014
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Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES): study design and methodology..
38:260-269.
2014
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Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial..
38:370-382.
2014
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The Healthy Home Offerings via the Mealtime Environment (HOME) Plus study: design and methods..
38:59-68.
2014
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Donepezil treatment of older adults with cognitive impairment and depression (DOTCODE study): clinical rationale and design..
37:200-208.
2014
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The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial..
37:272-283.
2014
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Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY)..
37:333-341.
2014
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Recruitment and retention rates in behavioral trials involving patients and a support person: a systematic review..
36:307-318.
2013
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Tailored Case Management for Diabetes and Hypertension (TEACH-DM) in a community population: study design and baseline sample characteristics..
36:298-306.
2013
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Unlocking the barriers to improved functional capacity in the elderly: rationale and design for the "Fit for Life trial"..
36:266-275.
2013
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Recruiting young adults into a weight loss trial: report of protocol development and recruitment results..
35:1-7.
2013
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The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics..
35:68-76.
2013
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Use of a randomized multiple baseline design: rationale and design of the spirited life holistic health intervention study..
35:138-152.
2013
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Considering patient diet preference to optimize weight loss: design considerations of a randomized trial investigating the impact of choice..
35:106-116.
2013
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Group physical therapy for veterans with knee osteoarthritis: study design and methodology..
34:296-304.
2013
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Nutrigenetic response to omega-3 fatty acids in obese asthmatics (NOOA): rationale and methods..
34:326-335.
2013
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Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial..
34:60-69.
2013
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Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE Phase 2) screening and recruitment: methods and results..
34:10-20.
2013
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Rationale and design of the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)..
34:136-144.
2013
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Informing the dosing of interventions in randomized trials..
33:1225-1230.
2012
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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
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Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design..
33:759-768.
2012
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If you build a rare disease registry, will they enroll and will they use it? Methods and data from the National Registry of Myotonic Dystrophy (DM) and Facioscapulohumeral Muscular Dystrophy (FSHD)..
33:302-311.
2012
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Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial..
33:184-196.
2012
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Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals..
33:197-205.
2012
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Sustainability and performance of the National Cancer Institute's Community Clinical Oncology Program..
33:46-54.
2012
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The CALERIE Study: design and methods of an innovative 25% caloric restriction intervention..
32:874-881.
2011
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Proactive recruitment of cancer patients' social networks into a smoking cessation trial..
32:498-504.
2011
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Kids and adults now! Defeat Obesity (KAN-DO): rationale, design and baseline characteristics..
32:461-469.
2011
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Strategic lessons from the clinical event classification process for the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial..
32:178-187.
2011
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Treatment of nonalcoholic fatty liver disease in children: TONIC trial design..
31:62-70.
2010
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Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations..
30:531-539.
2009
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An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial..
30:446-450.
2009
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Intracluster correlation adjustments to maintain power in cluster trials for binary outcomes..
30:473-480.
2009
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Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'..
30:256-268.
2009
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Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods..
30:178-189.
2009
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The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry..
30:116-122.
2009
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A simulation based technique to estimate intracluster correlation for a binary variable..
30:71-80.
2009
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The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer..
30:81-87.
2009
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Daily process methodology for measuring earlier antidepressant response..
29:867-877.
2008
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Integrating ancillary studies in a large clinical trial: the design and rationale of the APEX library..
29:887-895.
2008
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The Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology..
29:596-607.
2008