Contemporary Clinical Trials

Article	Citations
The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease	83
Remdesivir for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials	63
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	60
Inclusion and diversity in clinical trials: Actionable steps to drive lasting change	57
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	53
The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design	50
COVID-19 vaccines: Considering sex differences in efficacy and safety	47
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	45
Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019	42
Using digital technologies in clinical trials: Current and future applications	40
Design and outcome measures of LAVENDER, a phase 3 study of trofinetide for Rett syndrome	40
Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications	39
Demographic diversity of participants in Pfizer sponsored clinical trials in the United States	36
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	36
Sense2Stop: A micro-randomized trial using wearable sensors to optimize a just-in-time-adaptive stress management intervention for smoking relapse prevention	35
Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation	33
Implementation of platform trials in the COVID-19 pandemic: A rapid review	29
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	28
Open Dialogue compared to treatment as usual for adults experiencing a mental health crisis: Protocol for the ODDESSI multi-site cluster randomised controlled trial	26
Current druggable targets for therapeutic control of Alzheimer's disease	25
Harnessing mobile technology to reduce mental health disorders in college populations: A randomized controlled trial study protocol	25
Innovative trial designs and analyses for vaccine clinical development	23
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
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	22
Digital platforms for clinical trials: The Eureka experience	21

Decídetexto: Mobile cessation support for Latino smokers. Study protocol for a randomized clinical trial	21
Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations	20
Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men	19
Considerations to address missing data when deriving clinical trial endpoints from digital health technologies	19
Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices	19
Recruitment strategies and design considerations in a trial of resistance training to prevent dose-limiting toxicities in colon cancer patients undergoing chemotherapy	18
Predicting deseasonalised serum 25 hydroxy vitamin D concentrations in the D-Health Trial: An analysis using boosted regression trees	18
¡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	18
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	18
STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations	17
Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B)	17
Shotgun: A Bayesian seamless phase I-II design to accelerate the development of targeted therapies and immunotherapy	16
Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model	16
SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation	16
Effects of walking exercise training on learning and memory and hippocampal neuroimaging outcomes in MS: A targeted, pilot randomized controlled trial	16
Time-consuming and expensive data quality monitoring procedures persist in clinical trials: A national survey	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
Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV	16
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	16
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	16
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	16
Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial	16
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	16
What can be done to control the placebo response in clinical trials? A narrative review	16
Implementation of patient-reported outcome measures in real-world evidence studies: Analysis of ClinicalTrials.gov records (1999–2021)	16
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	16
Diversity, equity, and inclusion in clinical trials: A practical guide from the perspective of a trial sponsor	16
Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program	16
Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country	15
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	15
Controlled backfill in oncology dose-finding trials	15
Biorepository – A key component of research studies	15
A framework for setting enrollment goals to ensure participant diversity in sponsored clinical trials in the United States	15
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	15
Effect of Reducing Sedentary Behavior on Blood Pressure (RESET BP): Rationale, design, and methods	15
Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study	15
Omega-3 supplementation and heart failure: A meta-analysis of 12 trials including 81,364 participants	14
Health Characteristics and Aspirin Use in Participants at the Baseline of the ASPirin in Reducing Events in the Elderly – eXTension (ASPREE-XT) Observational Study	14
Clinical trial participation assessed by age, sex, race, ethnicity, and socioeconomic status	14
Adaptive design implementation in confirmatory trials: methods, practical considerations and case studies	14
Group mindful self-compassion training to improve mental health outcomes for LGBTQIA+ young adults: Rationale and protocol for a randomised controlled trial	14
Why ITT analysis is not always the answer for estimating treatment effects in clinical trials	14
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	14
Optimal Bayesian hierarchical model to accelerate the development of tissue-agnostic drugs and basket trials	13
Eligibility criteria and clinical trials: An FDA perspective	13
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	13
The shifting perspectives study protocol: Cognitive remediation therapy as an adjunctive treatment to family based treatment for adolescents with anorexia nervosa	13
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	13
Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework	13
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	13

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	13
Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study	12
RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol	12
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)	12
The mobile assistance for regulating smoking (MARS) micro-randomized trial design protocol	12
Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial	12
Design of a pragmatic clinical trial embedded in the Electronic Health Record: The VA's Diuretic Comparison Project	12
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	12
Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review	12
Age-based exclusions in clinical trials: A review and new perspectives	12
Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia – Study design and protocol	12
Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial	12
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	12
A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study	12
Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial	12
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	12
Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS)	12
The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial	11
Designing the Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease study	11
Implementation of a digital cognitive behavioral therapy for insomnia pathway in primary care	11
Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol	11
Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial	11
Two weights make a wrong: Cluster randomized trials with variable cluster sizes and heterogeneous treatment effects	11
Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic	11
Promoting physical activity participation and nutrition education through a telehealth intervention for children on the autism spectrum and their caregivers	11
Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants	11
Recruiting and retaining parents in behavioral intervention trials: Strategies to consider	11
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	10
A reanalysis of pain crises data from the pivotal l-glutamine in sickle cell disease trial	10
Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days	10
Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial	10
Rationale, study design and implementation of the LUCINDA Trial: Leuprolide plus Cholinesterase Inhibition to reduce Neurologic Decline in Alzheimer's	10
The many faces of recruitment in a randomized controlled trial	10
C-index regression for recurrent event data	10
Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol	10
Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial	10
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	10
Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care	10
Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France	10
The Pharmacist Discharge Care (PHARM-DC) study: A multicenter RCT of pharmacist-directed transitional care to reduce post-hospitalization utilization	10
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	10
Integration of a smartwatch within an internet-delivered intervention for depression: Protocol for a feasibility randomized controlled trial on acceptance	10
An open-label, non-inferiority randomized controlled trial of lidocAine Versus Opioids In MyocarDial Infarction study (AVOID-2 study) methods paper	10
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	10
A culturally tailored intervention to reduce risk of alcohol-exposed pregnancies in American Indian communities: Rationale, design, and methods	10
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
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	9
The neglect of sex: A call to action for including sex as a biological variable in placebo and nocebo research	9
Reporting and design of randomized controlled trials for COVID-19: A systematic review	9
Refusal rates and waivers of informed consent in pragmatic and comparative effectiveness RCTs: A systematic review	9
RAMIC: Design of a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ramipril in patients with COVID-19	9
Opportunity for efficiency in clinical development: An overview of adaptive clinical trial designs and innovative machine learning tools, with examples from the cardiovascular field	9
Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness 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
Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design	9
Transition to telehealth: Challenges and benefits of conducting group-based smoking and alcohol treatment virtually	9
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	9
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	9
The design and rationale of a multi-center randomized clinical trial comparing one avocado per day to usual diet: The Habitual Diet and Avocado Trial (HAT)	9
Rationale and design of the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial	9
Digital technologies and the democratization of clinical research: Social media, wearables, and artificial intelligence	9
Using plain language to communicate with clinical trials participants: Comparison of readability calculators	9
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
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	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
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	9
Independent drug action and its statistical implications for development of combination therapies	8
Evaluating the efficacy of mindfulness and acceptance-based treatment components for weight loss: Protocol for a multiphase optimization strategy trial	8
Operating characteristics are needed to properly evaluate the scientific validity of phase I protocols	8
An overview of the Connect through PLAY trial to increase physical activity in underserved adolescents	8
Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled	8
Should studies with no events in both arms be excluded in evidence synthesis?	8
Participant recruitment and retention from vulnerable populations in clinical trials is a matter of trust	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
Risk-based centralized data monitoring of clinical trials at the time of COVID-19 pandemic	8
Study of emotional distress in a comparative effectiveness trial of diabetes treatments: Rationale and design	8
Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial	8
Clinical trials in pregnancy and the “shadows of thalidomide”: Revisiting the legacy of Frances Kelsey	8
Design and methodology for an integrative data analysis of coping power: Direct and indirect effects on adolescent suicidality	8
Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial	8

Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed	8
Peer coach delivered storytelling program improved diabetes medication adherence: A cluster randomized trial	8
Causal inference methods for small non-randomized studies: Methods and an application in COVID-19	8
A randomized, double-blind, placebo-controlled clinical trial of 8-week intranasal oxytocin administration in adults with obesity: Rationale, study design, and methods	8
Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology	8
A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes	8
The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension	8
Design of Behavioral Economic Applications to Geriatrics Leveraging Electronic Health Records (BEAGLE): A pragmatic cluster randomized controlled trial	8
Are we any WISER yet? Progress and contemporary need for smart trials to include women in coronary artery disease trials	8
Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease	8
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
The Sleep, Cancer and Rest (SleepCaRe) Trial: Rationale and design of a randomized, controlled trial of cognitive behavioral and bright light therapy for insomnia and fatigue in women with breast canc	7
Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia	7
A technology assisted precision ketogenic diet intervention for cardio-renal-metabolic health in overweight or obese adults: Protocol for a randomized controlled trial	7
Ensuring diversity in clinical trials: The role of clinical pharmacology	7
Statistical considerations of phase 3 umbrella trials allowing adding one treatment arm mid-trial	7
Prevention of type 2 diabetes through remotely administered lifestyle programs: A systematic review	7
Strategies to optimize inclusion of women in multi-national clinical trials	7
Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial	7
A randomized trial of physical activity for cognitive functioning in breast cancer survivors: Rationale and study design of I Can! Improving Cognition After Cancer	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
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	7
Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial	7
Equity and bias in electronic health records data	7
Improving access for and experience of transgender and non-binary patients in clinical research: Insights from a transgender patient focus group and targeted literature reviews	7
Effect of brief interventions to promote behavior change on clinical outcomes of selected non-communicable diseases: The World Health Organization (WHO) Package of Essential Non-communicable disease (	7
A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic	7
Study design and implementation of the PRecision Medicine In MEntal health Care (PRIME Care) Trial	7
A customized adherence enhancement program for adolescents and young adults with suboptimal adherence and bipolar disorder: Trial design and methodological report	7
Design of CLARO (Collaboration Leading to Addiction Treatment and Recovery from other Stresses): A randomized trial of collaborative care for opioid use disorder and co-occurring depression and/or pos	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
South Asians Active Together (SAATH): Protocol for a multilevel physical activity intervention trial for South Asian American mother and daughter dyads	7
SHARING Choices: Design and rationale for a pragmatic trial of an advance care planning intervention for older adults with and without dementia in primary care	7
Development and implementation of standardized study performance metrics for a VA healthcare system clinical research consortium	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
Modified Application of Cardiac Rehabilitation in Older Adults (MACRO) Trial: Protocol changes in a pragmatic multi-site randomized controlled trial in response to the COVID-19 pandemic	7
Patient representativeness of a peripheral artery disease cohort in a randomized control trial versus a real-world cohort: The CLEVER trial versus the PORTRAIT registry	7
MIRROR-TCM: Multisite Replication of a Randomized Controlled Trial - Transitional Care Model	7
Patient navigation to promote lung cancer screening in a community health center for people experiencing homelessness: Protocol for a pragmatic randomized controlled trial	7
Health care coach support to assist with advance care planning and symptom management –A randomized controlled trial	7
HomeStyles-2: Randomized controlled trial protocol for a web-based obesity prevention program for families with children in middle childhood	6
Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation	6
Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics	6
Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial	6
A study protocol for MindMoves: A lifestyle physical activity and cognitive training intervention to prevent cognitive impairment in older women with cardiovascular disease	6
All systems are interrelated: Multilevel interventions with indigenous communities	6
Increasing diversity in research through dedicated language access services	6
REFINE (REduced Frequency ImmuNE checkpoint inhibition in cancers): A multi-arm phase II basket trial testing reduced intensity immunotherapy across different cancers	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
Integrating tobacco treatment into lung cancer screening practices: Study protocol for the Screen ASSIST randomized clinical trial	6
Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support	6
The COVID-19 Self-Testing through Rapid Network Distribution (C-STRAND) trial: A randomized controlled trial to increase COVID-19 testing in underserved populations	6
A cluster-randomized controlled trial of an elementary school drinking water access and promotion intervention: Rationale, study design, and protocol	6
Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagem	6
Correlates of knowledge of clinical trials among U.S. adults: Findings from the 2020 Health Information National Trends Survey	6
Innovation in the design of large-scale hybrid randomized clinical trials	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
Communication Coaching in Cardiology (CCC): A study protocol and methodological challenges and solutions of a randomized controlled trial in outpatient cardiology clinics	6
Technology-enhanced AcceleRation of Germline Evaluation for Therapy (TARGET): A randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline test	6
A community-informed recruitment plan template to increase recruitment of racial and ethnic groups historically excluded and underrepresented in clinical research	6
Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov	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
Standardization of the 6-min walk test in clinical trials of idiopathic pulmonary fibrosis	6
A hybrid approach of handling missing data under different missing data mechanisms: VISIBLE 1 and VARSITY trials for ulcerative colitis	6
Protocol: A cluster randomized controlled trial of a mobile application to support physical activity maintenance after an exercise oncology program	6
Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol	6
Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial	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
Challenges of conducting a remote behavioral weight loss study: Lessons learned and a practical guide	6
Changing Behaviour towards Aerobic and Strength Exercise (BASE): Design of a randomised, phase I study determining the safety, feasibility and consumer-evaluation of a remotely-delivered exercise prog	5
Design and methods of a randomized trial testing the novel Wellness Intervention for Smokers Living with HIV (WISH)	5
Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth	5
COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic	5
Design of a study to implement population-based risk assessment for hereditary cancer genetic testing in primary care	5
Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol	5
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
Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol	5
Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT	5
A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014–2018)	5
Development of novel measures for Alzheimer's disease prevention trials (NoMAD)	5
Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial	5
Recruitment and retention of emerging adults in lifestyle interventions: Findings from the REACH trial	5
Technical procedures and REDCap tools for internet-based clinical trials	5
Engaging smokers in research: Utility of Facebook in facilitating recruitment to a smoking cessation study	5
Evaluating the evaluators - Developing evidence of quality oversight effectiveness for clinical trial monitoring: Source data verification, source data review, statistical monitoring, key risk indicat	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
A randomized phase 3 trial evaluating antithrombin gamma treatment in Japanese patients with early-onset severe preeclampsia (KOUNO-TORI study): Study protocol	5
Trouble for trials - The worrying state of the research nurse workforce	5
Designing a virtual mental health consultation program to support and strengthen childcare centers impacted by COVID-19: A randomized controlled trial protocol	5
Controlled amplification in oncology dose-finding trials	5
Randomized controlled trial of the ehavioral ntervention for increasing hysical ctivity in ultiple clerosis project: Secondary, patient-reported outcomes	5
Stakeholder impact on the implementation of integrated care: Opportunities to consider for patient-centered outcomes research	5
Electronic health record based population health management to optimize care in CKD: Design of the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) trial	5
Rationale and protocol for a randomized waitlist controlled trial of videoconference delivered cognitive behaviour therapy for insomnia (CBT-I) to improve perceived cognitive impairment (PCI) among ca	5