Contemporary Clinical Trials

Article	Citations
Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change)	109
A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial stu	65
Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu Combined Ring Study, 2019	65
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	52
Promotion of Successful Weight Management in Overweight and Obese Veterans (POWER-VET): Trial Design and Methods	51
Editorial Board	44
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	44
Defining demographic cohorts in clinical trial populations using large electronic health records databases	44
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	43
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	34
Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial	34
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	33
Oral human papillomavirus (HPV) and associated factors among healthy populations: The design of the PROGRESS (PRevalence of Oral hpv infection, a Global aSSessment) study	32
Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016	31
Editorial Board	30
Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP): Feasibility and acceptability	28
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	27
Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS)	27
Restricted mean survival time based on Wu-Kolassa estimator compared to Kaplan-Meier estimator	23
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	23
Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program	23
MIRROR-TCM: Multisite Replication of a Randomized Controlled Trial - Transitional Care Model	23
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	22
Subgroup differences in calcium metabolism in response to dietary sodium: Rationale, design, and methods of a randomized, controlled, crossover dietary intervention in healthy adults	21
Open Dialogue compared to treatment as usual for adults experiencing a mental health crisis: Protocol for the ODDESSI multi-site cluster randomised controlled trial	21

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	21
The modified combo i3 + 3 design for novel-novel combination dose-finding trials in oncology	21
Study protocol: The Maternal Health Multilevel Intervention for Racial Equity (Maternal Health MIRACLE) Project	20
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	19
STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid thera	19
Designing a Bayesian adaptive clinical trial to evaluate novel mechanical ventilation strategies in acute respiratory failure using integrated nested Laplace approximations	19
Produce prescription to improve health among adults with type 2 diabetes in Australia: Protocol for a randomised controlled trial	19
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	18
Is exergaming a viable exercise option for obese black women?	18
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	18
Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol	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	18
The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods	17
Machine learning for detecting centre-level irregularities in randomized controlled trials: A pilot study	17
Evaluation of a brief psychosocial intervention for health anxiety delivered by medical assistants in primary care: Study protocol for a pilot hybrid trial	17
A framework for setting enrollment goals to ensure participant diversity in sponsored clinical trials in the United States	17
Practical considerations of promising zone design for interim sample size Re-estimation: An application to GRAPHITE for graft vs host disease	17
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	17
Factors associated with HIV self-testing and PrEP use among Nigerian youth: Baseline outcomes of a pragmatic, stepped-wedge, cluster-randomized controlled trial	17
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	16
Optimization of an mHealth lifestyle intervention for families with hereditary cancer syndromes: Study protocol for a multiphase optimization strategy feasibility study	16
Recruiting sexual minority youth for a drug abuse prevention trial: Comparing Instagram and Facebook	16
Editorial Board	16
I kua na'u "Let me carry out your last wishes" Clinical trial protocol to promote advance care planning among native Hawaiian populations	16
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	15
Better health through better housing – Current impact and future prospects of randomized trials	15
Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection	15
Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial	15
Optimizing a mobile just-in-time adaptive intervention (JITAI) for weight loss in young adults: Rationale and design of the AGILE factorial randomized trial	15
Design of the CHARGE study: A randomized control trial evaluating a novel treatment for Veterans with binge eating disorder and overweight and obesity	15
Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial	15
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	15
The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial	15
Digital technologies and the democratization of clinical research: Social media, wearables, and artificial intelligence	15
Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials	15
Design of a hybrid implementation effectiveness cluster randomized controlled trial of delivering written exposure therapy for PTSD in underserved primary care settings	14
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	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
Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study	14
DEcrease STress through RESilience training for Students (DESTRESS) Study: Protocol for a randomized controlled trial nested in a longitudinal observational cohort study	14
Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial	14
Evaluation of the survival-inferred fragility index to assess the robustness of the estimated treatment effect on survival endpoints	14
The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods	14
Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life	14
Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners	14
Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study	14
Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial	14
Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention	13
A study protocol to engage religious leaders to reduce blood pressure in Tanzanian communities: A cluster randomized trial	13
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	13

Inclusion of women in FDA-regulated premarket clinical trials: A call for innovative and recommended action	13
Integrative data analysis of clinical trials network studies to examine the impact of psychosocial treatments for Black people who use cocaine: Study protocol	13
A risk-based monitoring approach to source data monitoring and documenting monitoring findings	13
Mobile health plus community health worker support for weight management among public housing residents (Path to Health): A randomized controlled trial protocol	12
Rationale and design of the Heart-to-Heart study: A church-based intervention to reduce blood pressure in African Americans	12
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	12
Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects	12
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	12
A two-phase, prescriptive comparative effectiveness study to optimize the treatment of co-occurring insomnia and depression with digital interventions	12
Family model diabetes self-management education and support in faith-based organizations in the Republic of the Marshall Islands: A study protocol	12
Telephone informed consent in a pragmatic point-of-care clinical trial embedded in primary care	12
Improving the implementation of KiVa antibullying program with tailored support: Study protocol for a cluster randomized controlled trial	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	12
Assessment of added activity of an antitumor agent	11
Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial	11
Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial	11
A novel opt-in vs opt-out approach to referral-based treatment of tobacco use in Veterans Affairs (VA) primary care clinics: A provider-level randomized controlled trial protocol	11
RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting	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
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
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	11
Neurocognitive and neurobehavioral mechanisms of change following psychological treatment for alcohol use disorder	11
Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial	10
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	10
The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial	10
The “Latines Lideres En Salud (LaLiSa)” study: Rationale and design	10
A comparison of prolonged exposure therapy, pharmacotherapy, and their combination for PTSD: What works best and for whom; study protocol for a randomized trial	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
The effect of a trAnSitional Pharmacist Intervention in geRiatric inpatients on hospital visits after dischargE (ASPIRE): Protocol for a randomized controlled trial	10
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	10
Acceptance and commitment therapy for episodic migraine: Rationale and design of a pilot randomized controlled trial	10
eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol	10
Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors	10
The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis	9
Editorial Board	9
Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial	9
Structural innovation for hypoglycemia prevention in high-risk patients with type 2 diabetes: Design and implementation of a pragmatic, randomized, quality improvement trial	9
A clinical trial evaluating pharmacist-guided self-management of hypertension among veterans with CKD, rationale and study design	9
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	9
Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial	9
The COVID-19 Self-Testing through Rapid Network Distribution (C-STRAND) trial: A randomized controlled trial to increase COVID-19 testing in underserved populations	9
Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve three-year adherence to colorectal cancer screening among patients cared for i	9
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	9
Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men	9
A hybrid return to baseline imputation method to incorporate MAR and MNAR dropout missingness	9
Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial	9
Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity	9
Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment	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
Optimizing diabetes management interventions for Black and Hispanic adults using the multiphase optimization strategy: Protocol for a randomized mixed methods factorial trial	9
The use of enhanced intrinsic feedback for motor learning in stroke survivors: Clinical trial protocol	9
Assessing the role of correlation between efficacy and toxicity endpoints in the performance of Bayesian optimal phase II design	9
Editorial Board	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
Framing the statistical criteria for accelerated approval of oncology drugs: A pathway for front runners	9
Early intervention using written exposure therapy for PTSD and AUD symptoms following sexual assault: Description of design and methodology	8
An overview of the Be Well Home Health Navigator Program to reduce contaminants in well water: Design and methods	8
Modified reference based imputation and tipping point analysis in the presence of missing data due to COVID-19	8
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
The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy	8
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	8
2-in-1 adaptive design with dose optimization accounting for ranked dose response	8
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	8
Temporal trends and characteristics associated with racial, ethnic, and sex representation in COVID-19 clinical trials: A systematic review and meta-analysis	8
Combining antidepressants and attention bias modification in primary health care (DEPTREAT): Protocol for a pragmatic randomized controlled trial	8
Inclusion and diversity in clinical trials: Actionable steps to drive lasting change	8
Design and methods of a randomized trial testing the novel Wellness Intervention for Smokers Living with HIV (WISH)	8
A randomized controlled clinical trial to improve health outcomes in youth with type 1 diabetes: Study design and baseline characteristics	8
The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria	8
Prostate Assessment using Comparative Interventions – Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial	8
Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol	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
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	8
Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days	8
STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations	8
Protocol for the Promoting Resilience in Stress Management (PRISM) intervention: A multi-site randomized controlled trial for adolescents with type 1 diabetes	8
A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression	8
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	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
Family-wise type I error rate control for an extended 2-in-1 design with graphical approach in oncology drug development	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	7
Thank you to our Reviewers in 2023	7
Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment	7
Deconstructing the Kaplan-Meier curve: Quantification of treatment effect using the treatment effect process	7
Safety planning intervention and follow-up: A telehealth service model for suicidal individuals in emergency department settings: Study design and protocol	7
Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial	7
Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial	7
Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines	7
Recruiting families using social media versus pediatric obesity clinics: A secondary analysis of the Aim2Be RCT	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
Effect of cyclic daytime versus continuous enteral nutrition on circadian rhythms in critical illness (CIRCLES): Study protocol for a randomized controlled trial	7
Inefficiency of two-stage designs in phase II oncology clinical trials with high proportion of inevaluable patients	7
Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol	7
The COVID-19 Outpatient Pragmatic Platform Study (COPPS): Study design of a multi-center pragmatic platform trial	7
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	7
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	7
Integrating tobacco treatment into lung cancer screening practices: Study protocol for the Screen ASSIST randomized clinical trial	7
REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): Protocol for a multi-site feasibility randomised controlled trial	7
Development of StressCheck: A telehealth motivational enhancement therapy to improve voluntary engagement for PTSD treatment among active-duty service members	7
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	7
Web-Based Pain Coping Skills Training (PCST) for Managing Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors: Randomized Controlled Trial Protocol	7
Effects of virtual reality mindfulness on cognition and well-being in ALS: A randomized trial protocol	7
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	7
MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people	7
Hypoxaemic respiratory failure and awake prone ventilation (HYPER-AP) - Protocol for randomized, controlled clinical trial	7
Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program	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
Validation of the GetReal Trial Tool – Facilitating discussion and understanding more pragmatic design choices and their implications	7
Addressing missing outcome data in randomised controlled trials: A methodological scoping review	7
Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial	7
Implementing and assessing Bayesian response-adaptive randomisation for backfilling in dose-finding trials	6
Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study	6
Preterm-birth-prevention with Lactobacillus crispatus oral probiotics: Protocol for a double blinded randomised placebo-controlled trial (the PrePOP study)	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
The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients: Study protocol for the EMPOWER-Cancer-grief RCT	6
Rationale and design of the Prone Position and Respiratory Outcomes in Non-intubated COVID-19 PatiEnts: The “PRONE” Study	6
Optimization of dose selection using multiple surrogates of toxicity as a continuous variable in phase I cancer trial	6
Editorial Board	6
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	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
Feasibility of a positive psychology intervention (PATH) in allogeneic hematopoietic stem cell transplantation survivors: Randomized pilot trial design and methods	6
Lessons learned while starting multi-institutional genetics research in diverse populations: A report from the Clinical Sequencing Evidence-Generating Research (CSER) consortium	6
The EMBER trial for weight management engagement: A hybrid type 1 randomized controlled trial protocol	6
The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons	6
Food resources and kitchen skills plus aerobic training (FoRKS+) for black adults with hypertension: A pilot trial protocol	6
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	6
Advancing vaccine research in Africa: A comprehensive analysis of vaccine clinical trials landscape	6
Reopening schools safely and educating youth (ROSSEY) study: Protocol for a community-based, cluster randomized controlled trial	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
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
Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease: The FIRE-UP PD study	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
Editorial Board	6
The BROADEN study: The design of an observational study to assess the absolute burden of HPV-related head and neck cancers	6
A two-stage Bayesian adaptive design for minimum effective dose (MinED)-based dosing-finding trials	6
Design of a pragmatic clinical trial embedded in the Electronic Health Record: The VA's Diuretic Comparison Project	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
Protocol for a randomized clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa	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
Testing adaptive interventions to improve PTSD treatment outcomes in Federally Qualified Health Centers: Protocol for a randomized clinical trial	6
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory	6
Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial	6
A social worker intervention to reduce post-hospital mortality in HIV-infected adults in Tanzania (Daraja): Study protocol for a randomized controlled trial	6
Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial	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
Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory	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
Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD)	6
Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating	6
A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older African American women	6
Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations	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
Patient navigation to promote lung cancer screening in a community health center for people experiencing homelessness: Protocol for a pragmatic randomized controlled trial	6
A novel ‘social contract’ – An attempt to harmonize a sponsor's exploratory research with a clinical study participant's data rights	6
Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis	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
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
Participant recruitment and retention from vulnerable populations in clinical trials is a matter of trust	6
Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP): Study rationale and protocol	6
Using Bayesian pre-trial simulations to optimize the design of adaptive clinical trials in childhood nephrotic syndrome	5
Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials	5
An innovative protocol for the artificial speech-directed, contactless administration of laboratory-based comprehensive cognitive assessments: PAAD-2 trial management during the COVID-19 pandemic	5
Strengthening Older Adults Remembering (SOARing): Research protocol for a multi-site randomized clinical trial examining the efficacy of the Kessler Foundation modified Story Memory Technique (KF-mSMT	5
STEP-Home transdiagnostic group reintegration workshop to improve mental health outcomes for post-9/11 Veterans: Design, methods, and rationale for a randomized controlled behavioral trial	5
Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial	5
Correlative complexity: Insights into correlative management at a large academic cancer center	5
Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol	5
Corrigendum to “Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations” [Contemporary	5
Justification for unequal allocation ratios in clinical trials: A scoping review	5
Efficient stage-wise allocation ratios in multi-arm multi-stage designs	5
Technical procedures and REDCap tools for internet-based clinical trials	5
Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women	5
Randomized controlled trial of the ehavioral ntervention for increasing hysical ctivity in ultiple clerosis project: Secondary, patient-reported outcomes	5