Contemporary Clinical Trials

Article	Citations
The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease	68
Remdesivir for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials	60
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline	50
The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design	50
A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the	50
Inclusion and diversity in clinical trials: Actionable steps to drive lasting change	41
COVID-19 vaccines: Considering sex differences in efficacy and safety	36
The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis a	35
RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse	31
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials	31
Determining the effectiveness of early intensive versus escalation approaches for the treatment of relapsing-remitting multiple sclerosis: The DELIVER-MS study protocol	30
Design and outcome measures of LAVENDER, a phase 3 study of trofinetide for Rett syndrome	30
Using digital technologies in clinical trials: Current and future applications	30
Demographic diversity of participants in Pfizer sponsored clinical trials in the United States	28
Development of a core outcome set for pediatric critical care outcomes research	27
Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications	26
Sense2Stop: A micro-randomized trial using wearable sensors to optimize a just-in-time-adaptive stress management intervention for smoking relapse prevention	26
Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation	25
Implementation of platform trials in the COVID-19 pandemic: A rapid review	25
Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers	24
DO-HEALTH: Vitamin D3 - Omega-3 - Home exercise - Healthy aging and longevity trial - Design of a multinational clinical trial on healthy aging among European seniors	23
Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019	22
Optimization of prostate biopsy - Micro-Ultrasound versus MRI (OPTIMUM): A 3-arm randomized controlled trial evaluating the role of 29 MHz micro-ultrasound in guiding prostate biopsy in men with clini	22
Current druggable targets for therapeutic control of Alzheimer's disease	21
Harnessing mobile technology to reduce mental health disorders in college populations: A randomized controlled trial study protocol	20

The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight	20
Semiparametric Bayesian inference for the transmission dynamics of COVID-19 with a state-space model	19
Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations	19
Keyboard design for phase I drug-combination trials	19
Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor's perspective	19
Open Dialogue compared to treatment as usual for adults experiencing a mental health crisis: Protocol for the ODDESSI multi-site cluster randomised controlled trial	19
THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design	19
Innovative trial designs and analyses for vaccine clinical development	19
Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations	19
Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review	18
Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial	18
Early Detection Initiative: A randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes for early detection of pancreatic ductal adenocarcinoma	18
Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial	17
Emergency department safety assessment and follow-up evaluation 2: An implementation trial to improve suicide prevention	17
Practical considerations of utilizing propensity score methods in clinical development using real-world and historical data	17
Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure	16
Estimand framework: Delineating what to be estimated with clinical questions of interest in clinical trials	16
Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence	16
Predicting deseasonalised serum 25 hydroxy vitamin D concentrations in the D-Health Trial: An analysis using boosted regression trees	16
Digital platforms for clinical trials: The Eureka experience	16
Digital training for non-specialist health workers to deliver a brief psychological treatment for depression in India: Protocol for a three-arm randomized controlled trial	16
¡Mi Vida Saludable! A randomized, controlled, 2 × 2 factorial trial of a diet and physical activity intervention among Latina breast cancer survivors: Study design and methods	16
A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment	15
Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial	15
Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model	15
Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study	15
Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men	14
A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction	14
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	14
Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis	14
Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV	14
STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations	14
Decídetexto: Mobile cessation support for Latino smokers. Study protocol for a randomized clinical trial	14
A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) – Study protocol for a randomised controlled trial	14
Time-consuming and expensive data quality monitoring procedures persist in clinical trials: A national survey	14
The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2)	14
Effect of Reducing Sedentary Behavior on Blood Pressure (RESET BP): Rationale, design, and methods	14
Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B)	14
Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial	14
Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborativ	14
Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework	13
Considerations to address missing data when deriving clinical trial endpoints from digital health technologies	13
SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation	13
Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country	13
Biorepository – A key component of research studies	13
Evaluating treatments for posttraumatic stress disorder, alcohol and other drug use disorders using meta-analysis of individual patient data: Design and methodology of a virtual clinical trial	13
Key considerations in the design of real-world studies	13
Shotgun: A Bayesian seamless phase I-II design to accelerate the development of targeted therapies and immunotherapy	13
Clinical trial participation assessed by age, sex, race, ethnicity, and socioeconomic status	13
Recruitment strategies and design considerations in a trial of resistance training to prevent dose-limiting toxicities in colon cancer patients undergoing chemotherapy	13

Testing the effectiveness of community-engaged citizen science to promote physical activity, foster healthier neighborhood environments, and advance health equity in vulnerable communities: The Steps	12
Group mindful self-compassion training to improve mental health outcomes for LGBTQIA+ young adults: Rationale and protocol for a randomised controlled trial	12
Effects of walking exercise training on learning and memory and hippocampal neuroimaging outcomes in MS: A targeted, pilot randomized controlled trial	12
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus (COV-PREVENT): Study rationale and design	12
A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial	12
Trauma Informed Guilt Reduction (TrIGR) therapy for guilt, shame, and moral injury resulting from trauma: Rationale, design, and methodology of a two-site randomized controlled trial	12
Omega-3 supplementation and heart failure: A meta-analysis of 12 trials including 81,364 participants	12
N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial	12
Adaptive design implementation in confirmatory trials: methods, practical considerations and case studies	12
Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices	12
Why ITT analysis is not always the answer for estimating treatment effects in clinical trials	12
The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use diso	12
Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study	12
Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185)	11
Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants	11
Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomize	11
The effect of preventing subclinical transmission on the containment of COVID-19: Mathematical modeling and experience in Taiwan	11
Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review	11
The shifting perspectives study protocol: Cognitive remediation therapy as an adjunctive treatment to family based treatment for adolescents with anorexia nervosa	11
Covid-19 pandemic research opportunity: Is the Middle East & North Africa (MENA) missing out?	11
Controlled backfill in oncology dose-finding trials	11
Randomized controlled trial of the COPE-P intervention to improve mental health, healthy lifestyle behaviors, birth and post-natal outcomes of minority pregnant women: Study protocol with implications	11
A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study	11
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	11
Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program	11
Diversity, equity, and inclusion in clinical trials: A practical guide from the perspective of a trial sponsor	11
Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic	10
Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study	10
What can be done to control the placebo response in clinical trials? A narrative review	10
Optimal Bayesian hierarchical model to accelerate the development of tissue-agnostic drugs and basket trials	10
Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia – Study design and protocol	10
Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial	10
Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS)	10
The diagnosis of respiratory disease in children using a phone-based cough and symptom analysis algorithm: The smartphone recordings of cough sounds 2 (SMARTCOUGH-C 2) trial design	10
Integration of a smartwatch within an internet-delivered intervention for depression: Protocol for a feasibility randomized controlled trial on acceptance	10
Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days	10
Recruiting and retaining parents in behavioral intervention trials: Strategies to consider	10
Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol	10
Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial	10
Study Protocol: A randomized controlled trial of suicide risk reduction in the year following jail release (the SPIRIT Trial)	10
Implementation of patient-reported outcome measures in real-world evidence studies: Analysis of ClinicalTrials.gov records (1999–2021)	10
An open-label, non-inferiority randomized controlled trial of lidocAine Versus Opioids In MyocarDial Infarction study (AVOID-2 study) methods paper	10
Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons	9
A reanalysis of pain crises data from the pivotal l-glutamine in sickle cell disease trial	9
RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol	9
The mobile assistance for regulating smoking (MARS) micro-randomized trial design protocol	9
The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer	9
The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial	9
N-Acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis (NACPMS) trial: Study protocol for a randomized, double-blind, placebo-controlled add-on phase 2 trial	9
C-index regression for recurrent event data	9
Selecting appropriate endpoints for assessing treatment effects in comparative clinical studies for COVID-19	9
Reporting and design of randomized controlled trials for COVID-19: A systematic review	9
Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial pr	9
Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial	9
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	9
Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop we	9
Design of a pragmatic clinical trial embedded in the Electronic Health Record: The VA's Diuretic Comparison Project	9
The “Talk-to-Me” MOOC intervention for suicide prevention and mental health education among tertiary students: Protocol of a multi-site cross-over randomised controlled trial	9
A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol	9
The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans	9
Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial	9
Eligibility criteria and clinical trials: An FDA perspective	9
Design considerations for phase I/II dose finding clinical trials in Immuno-oncology and cell therapy	9
A culturally tailored intervention to reduce risk of alcohol-exposed pregnancies in American Indian communities: Rationale, design, and methods	9
Promoting physical activity participation and nutrition education through a telehealth intervention for children on the autism spectrum and their caregivers	9
The Pharmacist Discharge Care (PHARM-DC) study: A multicenter RCT of pharmacist-directed transitional care to reduce post-hospitalization utilization	8
Fragility of clinical trials across research fields: A synthesis of methodological reviews	8
Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a random	8
Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial	8
Evaluating the efficacy of mindfulness and acceptance-based treatment components for weight loss: Protocol for a multiphase optimization strategy trial	8
RAMIC: Design of a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ramipril in patients with COVID-19	8
A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings	8
Does the COVID-19 outbreak identify a broader need for an urgent transformation of cancer clinical trials research?	8
Rationale, study design and implementation of the LUCINDA Trial: Leuprolide plus Cholinesterase Inhibition to reduce Neurologic Decline in Alzheimer's	8
Extensions of the 2-in-1 adaptive design	8
A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures	8
A new framework to address challenges in quantitative benefit-risk assessment for medical products	8
Causal inference methods for small non-randomized studies: Methods and an application in COVID-19	8
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-Hi	8
Two weights make a wrong: Cluster randomized trials with variable cluster sizes and heterogeneous treatment effects	8

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)	8
Acupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue	8
Rationale and design of the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial	8
Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial	8
Implementing expanded COVID-19 testing in Massachusetts community health centers through community partnerships: Protocol for an interrupted time series and stepped wedge study design	8
Study of emotional distress in a comparative effectiveness trial of diabetes treatments: Rationale and design	8
Independent drug action and its statistical implications for development of combination therapies	8
Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology	8
Implementation of a digital cognitive behavioral therapy for insomnia pathway in primary care	8
Age-based exclusions in clinical trials: A review and new perspectives	8
A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes	8
A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol	8
Design and methodology for an integrative data analysis of coping power: Direct and indirect effects on adolescent suicidality	8
Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial	7
The neglect of sex: A call to action for including sex as a biological variable in placebo and nocebo research	7
Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a mu	7
Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimenta	7
Operating characteristics are needed to properly evaluate the scientific validity of phase I protocols	7
A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial	7
Statistical considerations of phase 3 umbrella trials allowing adding one treatment arm mid-trial	7
The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain	7
Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled	7
Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care	7
Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial	7
Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREAT	7
Independent action models and prediction of combination treatment effects for response rate, duration of response and tumor size change in oncology drug development	7
Risk-based centralized data monitoring of clinical trials at the time of COVID-19 pandemic	7
The COVID-19 Self-Testing through Rapid Network Distribution (C-STRAND) trial: A randomized controlled trial to increase COVID-19 testing in underserved populations	7
Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reduc	7
IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse	7
The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension	7
Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed	7
Proactive health support (PaHS) – telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial	7
Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease	7
Dynamic treatment regimens in small n, sequential, multiple assignment, randomized trials: An application in focal segmental glomerulosclerosis	7
A culturally and gender responsive stress and chronic disease prevention intervention for low/no-income African American men: The MOCHA moving forward randomized control trial protocol	7
Refusal rates and waivers of informed consent in pragmatic and comparative effectiveness RCTs: A systematic review	7
Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial	7
Clinical trials in pregnancy and the “shadows of thalidomide”: Revisiting the legacy of Frances Kelsey	7
The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury	7
The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United St	7
Opportunity for efficiency in clinical development: An overview of adaptive clinical trial designs and innovative machine learning tools, with examples from the cardiovascular field	7
Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial	7
The many faces of recruitment in a randomized controlled trial	7
Yathu Yathu (“For us, by us”): Design of a cluster-randomised trial of the impact of community-based, peer-led comprehensive sexual and reproductive health services for adolescents and young people ag	6
Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder s	6
Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness	6
An overview of the Connect through PLAY trial to increase physical activity in underserved adolescents	6
A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic	6
Increasing diversity in research through dedicated language access services	6
Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial	6
Are we any WISER yet? Progress and contemporary need for smart trials to include women in coronary artery disease trials	6
Communication Coaching in Cardiology (CCC): A study protocol and methodological challenges and solutions of a randomized controlled trial in outpatient cardiology clinics	6
Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design	6
Design of Behavioral Economic Applications to Geriatrics Leveraging Electronic Health Records (BEAGLE): A pragmatic cluster randomized controlled trial	6
Community-based intervention effects on older adults' physical activity and falls: Protocol and rationale for a randomized optimization trial (Ready Steady3.0)	6
Data monitoring committees for clinical trials evaluating treatments of COVID-19	6
Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial)	6
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 nec	6
Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with inf	6
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	6
Recruitment patterns in multicentre randomised trials fit more closely to Price's Law than the Pareto Principle: A review of trials funded and published by the United Kingdom Health Technology Assessm	6
Time limited eating in adolescents with obesity (time LEAd): Study protocol	6
Digital technologies and the democratization of clinical research: Social media, wearables, and artificial intelligence	6
A framework for setting enrollment goals to ensure participant diversity in sponsored clinical trials in the United States	6
Peer coach delivered storytelling program improved diabetes medication adherence: A cluster randomized trial	6
Modifying Diet and Exercise in MS (MoDEMS): Study design and protocol for a telehealth weight loss intervention for adults with obesity & Multiple Sclerosis	6
A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled	6
Using plain language to communicate with clinical trials participants: Comparison of readability calculators	6
Designing the Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease study	6
Transition to telehealth: Challenges and benefits of conducting group-based smoking and alcohol treatment virtually	6
Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol	6
Application of machine learning methods to bridge the gap between non-interventional studies and randomized controlled trials in ophthalmic patients with neovascular age-related macular degeneration	6
Protocol: A cluster randomized controlled trial of a mobile application to support physical activity maintenance after an exercise oncology program	6
Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care	6
Strategies to optimize inclusion of women in multi-national clinical trials	6
Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods	6
Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol	6
Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol	6
Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings	6
Isradipine enhancement of virtual reality cue exposure for smoking cessation: Rationale and study protocol for a double-blind randomized controlled trial	6
A customized adherence enhancement program for adolescents and young adults with suboptimal adherence and bipolar disorder: Trial design and methodological report	6
Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov	6
The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer	5
Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial	5
Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France	5
Engaging smokers in research: Utility of Facebook in facilitating recruitment to a smoking cessation study	5
MIRROR-TCM: Multisite Replication of a Randomized Controlled Trial - Transitional Care Model	5
Study design and implementation of the PRecision Medicine In MEntal health Care (PRIME Care) Trial	5
Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT	5
Stakeholder impact on the implementation of integrated care: Opportunities to consider for patient-centered outcomes research	5
The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness–implementation trial in integrated primary care (the healthy communities 4 healthy students study)	5
Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial	5
Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol	5
Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes	5