Contemporary Clinical Trials

Article	Citations
Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP): Feasibility and acceptability	74
A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial stu	72
Subgroup differences in calcium metabolism in response to dietary sodium: Rationale, design, and methods of a randomized, controlled, crossover dietary intervention in healthy adults	46
Promotion of Successful Weight Management in Overweight and Obese Veterans (POWER-VET): Trial Design and Methods	40
A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening	29
Protocol for a multicenter, double-blinded placebo-controlled randomized controlled trial comparing intravenous ferric derisomaltose to oral ferrous sulfate for the treatment of iron deficiency anemia	29
Defining demographic cohorts in clinical trial populations using large electronic health records databases	28
Designing a Bayesian adaptive clinical trial to evaluate novel mechanical ventilation strategies in acute respiratory failure using integrated nested Laplace approximations	28
Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program	27
Is exergaming a viable exercise option for obese black women?	26
A clinical trial protocol of a single-session self-guided acceptance-based online intervention targeting food cravings as predictors of disordered eating in pregnant people	25
Toe-in and toe-out gait retraining interventions to reduce proxy measures of medial knee joint load in people with medial knee osteoarthritis: Protocol for a randomised placebo-controlled trial	25
The electronic health record Risk of Alzheimer’s and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm	24
Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu Combined Ring Study, 2019	21
Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change)	20
Study protocol: The Maternal Health Multilevel Intervention for Racial Equity (Maternal Health MIRACLE) Project	20
Protocol: Implementation evaluation of a combination intervention for sustainable blood pressure control in rural KwaZulu-Natal, South Africa (IMPACT BP): A three-arm, unblinded, parallel group indivi	20
Project EPIC (Empowering People to Independence in COPD): Study protocol for a hybrid effectiveness-implementation pilot randomized controlled trial of telephonic, geriatrics-palliative care nurse-coa	19
Produce prescription to improve health among adults with type 2 diabetes in Australia: Protocol for a randomised controlled trial	19
Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial	19
Two equivalent formulations of conditional power and predictive probability of success in interim monitoring	18
Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation	18
A cognitive dissonance-based intervention to reduce ultra-processed food intake: Protocol for a pilot randomized controlled trial	18
The STRONG STAR adverse events monitoring program for psychological health clinical trials	18
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	18

Rifampicin combination therapy versus targeted antimicrobial monotherapy in the oral antimicrobial treatment phase of staphylococcal prosthetic joint infection (RiCOTTA-trial): protocol for a randomiz	17
Corrigendum to “DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care” [Contemporary Clinical Tri	17
Protocol for a multisite, parallel-group, randomized clinical trial comparing a brief tele-cognitive behavioral therapy intervention (BRIGHT) with attention control for the reduction of body image-rel	16
Study protocol for a duration-randomized clinical trial to determine the optimal length of treatment for multidrug-resistant tuberculosis with a 5-drug regimen: The DRAMATIC trial	16
Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol	16
Restricted mean survival time based on Wu-Kolassa estimator compared to Kaplan-Meier estimator	16
The modified combo i3 + 3 design for novel-novel combination dose-finding trials in oncology	16
Preference for behavior change strategies in randomized controlled trials: Evidence from weight management	15
Comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals: Statistical analysis plan for a cluster-randomised controlled	15
Protocol for VetASSIST: A randomized controlled trial to evaluate virtual peer health coaching for veterans with multimorbidity	15
Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection	14
I kua na'u "Let me carry out your last wishes" Clinical trial protocol to promote advance care planning among native Hawaiian populations	14
Evaluating missing outcome data methods for the analysis of the MEL-SELF trial of patient-led surveillance for early-stage melanoma: A simulation study	14
Editorial Board	14
Implementing changing behaviour towards aerobic and strength exercise: Results of a randomised, phase I study determining the safety, feasibility, and consumer-evaluation of an online exercise program	14
Better health through better housing – Current impact and future prospects of randomized trials	13
Multi-site feasibility and fidelity of remote yoga intervention to improve management of type-2 diabetes: Design and methods of the HA1C (Healthy Active and In Control) study	13
A framework for setting enrollment goals to ensure participant diversity in sponsored clinical trials in the United States	13
Effectiveness of a pharmacist-delivered primary care telemedicine intervention to increase access to pharmacotherapy and specialty treatment for alcohol use problems: Protocol for the alcohol telemedi	13
Design of the CHARGE study: A randomized control trial evaluating a novel treatment for Veterans with binge eating disorder and overweight and obesity	13
The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods	13
Digital technologies and the democratization of clinical research: Social media, wearables, and artificial intelligence	13
Optimizing a mobile just-in-time adaptive intervention (JITAI) for weight loss in young adults: Rationale and design of the AGILE factorial randomized trial	13
Recruiting sexual minority youth for a drug abuse prevention trial: Comparing Instagram and Facebook	13
Extending the vision of adaptive point-of-care platform trials to improve targeted use of drug therapy regimens: An agile approach in the learning healthcare system toolkit	13
An innovative approach to aligning healthcare with what matters most to patients: A hybrid type 1 trial protocol of patient priorities care for older adults with multiple chronic conditions	13
Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life	13
Early intervention versus treatment as usual for adolescents with first-episode psychosis: Protocol for the randomized OPUS YOUNG trial	13
Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial	13
Factors associated with HIV self-testing and PrEP use among Nigerian youth: Baseline outcomes of a pragmatic, stepped-wedge, cluster-randomized controlled trial	12
Design of a hybrid implementation effectiveness cluster randomized controlled trial of delivering written exposure therapy for PTSD in underserved primary care settings	12
Effect of mindfulness-based intervention on endurance performance under pressure and performance-relevant mental attributes, an interdisciplinary perspective: Protocol for a Mindfulness-Based Peak Per	12
DEcrease STress through RESilience training for Students (DESTRESS) Study: Protocol for a randomized controlled trial nested in a longitudinal observational cohort study	12
The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial	12
Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial	12
Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study	12
Machine learning for detecting centre-level irregularities in randomized controlled trials: A pilot study	12
Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners	12
Addressing chronic pain and suicide risk using Mindfulness-Based Cognitive Therapy: Rationale, design and baseline characteristics	12
Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects	12
Practical considerations of promising zone design for interim sample size Re-estimation: An application to GRAPHITE for graft vs host disease	12
INteractive survivorship program to improve health care REsources [INSPIRE]: A study protocol testing a digital intervention with stepped care telehealth to improve outcomes for adolescent and young a	11
DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial	11
Editorial Board	11
Family model diabetes self-management education and support in faith-based organizations in the Republic of the Marshall Islands: A study protocol	11
A two-phase, prescriptive comparative effectiveness study to optimize the treatment of co-occurring insomnia and depression with digital interventions	11
Telephone informed consent in a pragmatic point-of-care clinical trial embedded in primary care	11
Risk of relapse to non-opioid addictive substances among opioid dependent patients treated with an opioid receptor antagonist or a partial agonist: A randomized clinical trial	11
Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer	11
Corrigendum to “Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study” [Contemporary Clinical Trials Volume 126 (2	11

Improving the implementation of KiVa antibullying program with tailored support: Study protocol for a cluster randomized controlled trial	11
An adapted brief negotiation interview for alcohol and cannabis use among assault-injured emerging adults: A randomized pilot trial protocol	10
Implementation of two non-drug pain prescriptions for musculoskeletal pain in primary care clinics	10
Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors	10
Assessment of added activity of an antitumor agent	10
Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial	10
Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial	10
COVID Prevention Program: Rationale and methodology of a tailored behavioral intervention to prevent household and community spread of COVID-19 among Latinos	10
Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study	10
Mobile health plus community health worker support for weight management among public housing residents (Path to Health): A randomized controlled trial protocol	10
Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumati	10
Rationale and design of the Heart-to-Heart study: A church-based intervention to reduce blood pressure in African Americans	10
Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention	10
Evaluation of the survival-inferred fragility index to assess the robustness of the estimated treatment effect on survival endpoints	10
Bilingual randomized controlled trial design, of a telephone-based intervention to promote rehabilitation adherence; A study focus on recruitment of Hispanic children with traumatic brain injury	10
Sex differences in clinical trial enrollment in the United States across psychiatric disorders	10
Evaluating the role of financial navigation in alleviating financial distress among young adults with a history of blood cancer: A hybrid type 2 randomized effectiveness-implementation design	10
Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension	10
A randomized clinical trial of multi-level intervention to improve colorectal cancer screening rates at multiple federally qualified health care centers in New York City	10
A risk-based monitoring approach to source data monitoring and documenting monitoring findings	10
Integrative data analysis of clinical trials network studies to examine the impact of psychosocial treatments for Black people who use cocaine: Study protocol	10
Design and protocol of a pragmatic clinical trial to improve cognitive impairment detection in primary care	9
Neurocognitive and neurobehavioral mechanisms of change following psychological treatment for alcohol use disorder	9
Prehabilitation in oncological patients undergoing major gastrointestinal surgery: rationale and design of the PROGRESS trial	9
The COMPASS study: A prospective, randomized, multi-center trial testing the impact of a clinic-based intervention informing patients of colorectal cancer screening options on screening completion	9
The “Latines Lideres En Salud (LaLiSa)” study: Rationale and design	9
Optimizing diabetes management interventions for Black and Hispanic adults using the multiphase optimization strategy: Protocol for a randomized mixed methods factorial trial	9
Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial	9
Addressing challenges in outreach and recruitment: A case study of an NIH-funded randomized controlled trial	9
The influence of ultra-processed food consumption on reward processing and energy intake: Background, design, and methods of a controlled feeding trial in adolescents and young adults	9
A study protocol to engage religious leaders to reduce blood pressure in Tanzanian communities: A cluster randomized trial	9
Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framewor	9
A hybrid return to baseline imputation method to incorporate MAR and MNAR dropout missingness	9
Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors	9
Assessing the role of correlation between efficacy and toxicity endpoints in the performance of Bayesian optimal phase II design	9
Multi-hospital electronic decision support for drug-associated acute kidney injury (MEnD-AKI): Study protocol for a randomized clinical trial	9
Acceptance and commitment therapy for episodic migraine: Rationale and design of a pilot randomized controlled trial	9
A randomized controlled clinical trial to improve health outcomes in youth with type 1 diabetes: Study design and baseline characteristics	9
Editorial Board	9
Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial	9
Study protocol for a non-inferiority, multicenter, randomized study to evaluate a smartphone app-based follow-up program after bariatric surgery (BELLA plus trial)	9
The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial	9
A randomized controlled trial to test the efficacy of a diabetes behavioral intervention to prevent memory decline in older blacks/African Americans with diabetes and mild cognitive impairment	8
Framing the statistical criteria for accelerated approval of oncology drugs: A pathway for front runners	8
Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment	8
Temporal trends and characteristics associated with racial, ethnic, and sex representation in COVID-19 clinical trials: A systematic review and meta-analysis	8
Engaging staff to improve COVID-19 vaccination response at long-term care facilities (ENSPIRE): A cluster randomized trial of co-designed, tailored vaccine promotion materials	8
Recruiting families using social media versus pediatric obesity clinics: A secondary analysis of the Aim2Be RCT	8
Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial	8
The use of enhanced intrinsic feedback for motor learning in stroke survivors: Clinical trial protocol	8
Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer s	8
Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial	8
Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial	8
Structural innovation for hypoglycemia prevention in high-risk patients with type 2 diabetes: Design and implementation of a pragmatic, randomized, quality improvement trial	8
Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment	8
Adaptive interventions for alcohol misuse and violent behaviors among adolescents and emerging adults in the emergency department: A sequential multiple assignment randomized controlled trial protocol	8
eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol	8
Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity	8
A comparison of prolonged exposure therapy, pharmacotherapy, and their combination for PTSD: What works best and for whom; study protocol for a randomized trial	8
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	8
Deconstructing the Kaplan-Meier curve: Quantification of treatment effect using the treatment effect process	8
Editorial Board	8
Effect of cyclic daytime versus continuous enteral nutrition on circadian rhythms in critical illness (CIRCLES): Study protocol for a randomized controlled trial	8
Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation	8
A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression	8
Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial	8
Corrigendum to: Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics (Contemporary Clinica	8
The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis	8
Combining antidepressants and attention bias modification in primary health care (DEPTREAT): Protocol for a pragmatic randomized controlled trial	8
A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older women living with disabilities	8
The effect of a trAnSitional Pharmacist Intervention in geRiatric inpatients on hospital visits after dischargE (ASPIRE): Protocol for a randomized controlled trial	8
Protocol for the Promoting Resilience in Stress Management (PRISM) intervention: A multi-site randomized controlled trial for adolescents with type 1 diabetes	8
Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project	8
REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): Protocol for a multi-site feasibility randomised controlled trial	8
Safety planning intervention and follow-up: A telehealth service model for suicidal individuals in emergency department settings: Study design and protocol	8
The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy	8
Editorial Board	8
Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt	8
Introducing the Adherence Promotion with Person-centered Technology (APPT) trial: Rationale, methods, and baseline characteristics	8
Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program	8

Early intervention using written exposure therapy for PTSD and AUD symptoms following sexual assault: Description of design and methodology	8
Family-wise type I error rate control for an extended 2-in-1 design with graphical approach in oncology drug development	8
A clinical trial evaluating pharmacist-guided self-management of hypertension among veterans with CKD, rationale and study design	8
Optimising a digital intervention to support parents experiencing socio-economic disadvantage to improve adolescent health behaviours: Protocol for the Health4Life Parents & Teens factorial trial	8
A randomized, cross-over trial comparing the effect of innovative robotic gait training and functional clinical therapy in children with cerebral palsy; a protocol to test feasibility	7
Protocol of a cluster randomized controlled trial of a village health worker care model to reduce cardiovascular disease risk among conflict-affected populations in eastern Myanmar	7
Hypoxaemic respiratory failure and awake prone ventilation (HYPER-AP) - Protocol for randomized, controlled clinical trial	7
Feasibility of a positive psychology intervention (PATH) in allogeneic hematopoietic stem cell transplantation survivors: Randomized pilot trial design and methods	7
Reopening schools safely and educating youth (ROSSEY) study: Protocol for a community-based, cluster randomized controlled trial	7
Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial	7
Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP): Study rationale and protocol	7
Sleep coach intervention for adolescents with type 1 diabetes: Rationale and trial design	7
Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study	7
MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people	7
An overview of the Be Well Home Health Navigator Program to reduce contaminants in well water: Design and methods	7
Protocol for a pilot RCT investigating a weight loss navigation program for adults	7
Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial	7
Participant recruitment and retention from vulnerable populations in clinical trials is a matter of trust	7
Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating	7
Protocol for a randomized controlled trial comparing phone-based prenatal mindfulness training to usual care for pregnant people at risk for hypertensive disorders of pregnancy	7
Evaluating a multi-behavioural home-based intervention for reducing depressive symptoms in postnatal women : The food, move, sleep (FOMOS) for postnatal mental health randomised controlled trial proto	7
Thank you to our Reviewers in 2023	7
Rationale and study design for a randomized clinical trial of HOPE-genomics, a web-based intervention to improve cancer patients' understanding of genomic testing results	7
2-in-1 adaptive design with dose optimization accounting for ranked dose response	7
Addressing missing outcome data in randomised controlled trials: A methodological scoping review	7
Effects of virtual reality mindfulness on cognition and well-being in ALS: A randomized trial protocol	7
Prostate Assessment using Comparative Interventions – Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial	7
The short-term effect of high dose vitamin D3 supplementation in improving hypovitaminosis in patients with type 2 diabetes - A randomized clinical trial	7
Testing adaptive interventions to improve PTSD treatment outcomes in Federally Qualified Health Centers: Protocol for a randomized clinical trial	7
Web-Based Pain Coping Skills Training (PCST) for Managing Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors: Randomized Controlled Trial Protocol	7
Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial	7
Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines	7
BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based tripl	7
Association of study visit interval length with follow-up completeness and adherence to assigned study drug dose: A randomized comparison of participants in the ADAPTABLE trial	7
Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol	7
Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol	7
Food resources and kitchen skills plus aerobic training (FoRKS+) for black adults with hypertension: A pilot trial protocol	6
Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD)	6
A double-blind randomized clinical trial of zonisamide and contingency management for alcohol use disorder treatment (ZARRA) protocol	6
Should studies with no events in both arms be excluded in evidence synthesis?	6
Editorial Board	6
Corrigendum to “Reopening schools safely and educating youth (ROSSEY) study: Protocol for a community-based, cluster randomized controlled trial” [Contemporary Clinical Trials, 139 (2024) 107480]	6
Evaluation of a monoclonal antibody against respiratory syncytial virus, clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials	6
Comparing primary-tertiary multidisciplinary collaborative care with usual care in community patients with atrial fibrillation: The protocol for a cluster randomized controlled trial	6
Validation of the GetReal Trial Tool – Facilitating discussion and understanding more pragmatic design choices and their implications	6
Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol	6
The EMBER trial for weight management engagement: A hybrid type 1 randomized controlled trial protocol	6
Editorial Board	6
The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients: Study protocol for the EMPOWER-Cancer-grief RCT	6
Design and implementation of data collection and linkage of electronic health records in a large UK cluster-randomised trial of asthma management (ARRISA-UK)	6
Protocol for the implementation and referral of the ecofit physical activity intervention within Diabetes Alliance Program Plus among regional, rural and remote people with type 2 diabetes in a primar	6
Assessing attitudes towards pediatric research participation across diverse populations: Psychometric properties of a novel tool	6
Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory	6
The effectiveness of knee-chest-flexion maneuver in reducing respiratory distress in elective cesarean section newborns: protocol for a randomized controlled trial	6
The Exercise aNd hEArt transplant (ENEA) trial – a registry-based randomized controlled trial evaluating the safety and efficacy of cardiac telerehabilitation after heart transplant	6
How ultra-processed foods modulate cardiometabolic risk: A 2 × 2 factorial randomized controlled trial protocol in healthy adults	6
Strategies to improve the recruitment and retention of underserved children and families in clinical trials: A case example of a school-supervised asthma therapy pilot	6
Implementing and assessing Bayesian response-adaptive randomisation for backfilling in dose-finding trials	6
Lessons learned while starting multi-institutional genetics research in diverse populations: A report from the Clinical Sequencing Evidence-Generating Research (CSER) consortium	6
Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study	6
Mothers Inspiring Healthy Actions (MIHA) program: A randomized control trial testing obesity treatment for mother-daughter dyads	6
The 4 youth by youth (4YBY) crowdsourced HIV prevention intervention: A stepped-wedge longitudinal trial on HIV self-testing uptake among adolescents and young people in Nigeria	6
A novel ‘social contract’ – An attempt to harmonize a sponsor's exploratory research with a clinical study participant's data rights	6
Protocol for a randomized clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa	6
Neurologic music therapy combined with EEG-tDCS for upper motor extremity performance in patients with corticobasal syndrome: Study protocol for a novel approach	6
Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis	6
Editorial Board	6
Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations	6
Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease: The FIRE-UP PD study	6
Leveraging external evidence using Bayesian hierarchical model and propensity score in the presence of covariates	6
Study protocol for weSurvive: A feasibility trial of a digital health intervention to improve quality of life and health behaviors of Appalachian cancer survivors	6
Protocol for a single-arm, multi-component behavior change technique (BCT) intervention to develop a walking habit among caregivers for persons with Alzheimer disease and related dementias (ADRD)	6
Advancing vaccine research in Africa: A comprehensive analysis of vaccine clinical trials landscape	6
Geographic location and clinical trial knowledge, invitation, and participation among adults in the United States	6
The Chrono-Vax trial protocol: The effect of the time of day of influenza vaccination on immune responses in adults aged 60–85 years	6
Comparative effectiveness of trauma-focused and non-trauma-focused psychotherapy for PTSD among veterans with comorbid substance use disorders: Protocol & rationale for a randomized clinical trial	6
Inefficiency of two-stage designs in phase II oncology clinical trials with high proportion of inevaluable patients	6
Editorial Board	6
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory	6
Editorial Board	6
Study protocol for a randomized, placebo-controlled, double-masked mechanistic clinical trial of transdermal estrogen replacement in hypoestrogenic eating disorders to explore the role of estrogen on	6
Development of StressCheck: A telehealth motivational enhancement therapy to improve voluntary engagement for PTSD treatment among active-duty service members	6
An evaluation of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) in a youth outpatient eating disorders service: A protocol paper	6
Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for olde	6
Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial	5
Editorial Board	5
Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials	5
The Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on ca	5
The quasi-CRM shift method for partially ordered groups	5
Randomized controlled trial of an Asian culture-tailored lung health intervention study for Chinese and Korean Americans: Study protocol	5
Using Bayesian pre-trial simulations to optimize the design of adaptive clinical trials in childhood nephrotic syndrome	5
A nutrition education intervention to improve eating behaviors of children with autism spectrum disorder: Study protocol for a pilot randomized controlled trial	5
Underrepresentation of black individuals in pivotal trials for novel anticancer drugs: Potential consequence of using estimated creatinine clearance to assess kidney function?	5
Adjusting confidence intervals under covariate-adaptive randomization in non-inferiority and equivalence trials	5
Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot randomized controlled trial	5