A #Digital #Diabetes Prevention Program for Hispanic Adolescents (Fit24+): #Protocol for a Feasibility #RCT #ClinicalTrial Background: Hispanic youth are disproportionately impacted by obesity and subsequent type 2 #Diabetes (T2D) yet remain underrepresented in #Diabetes prevention #Research. #Digital health interventions hold promise for increasing the accessibility to and engagement in disease prevention programming, particularly among high-risk populations. However, there is a significant gap in the literature regarding #Digital T2D prevention programs for adolescents or Hispanic youth. Objective: The objective of this article is to describe the #Protocol for examining the feasibility of a 12-week #Digital #Diabetes prevention program among Hispanic adolescents with obesity. Methods: Participants (N=40; aged 12-16 years) will be randomized (1:1) to a 12-week intervention group or a control group. Youth in the intervention group will receive access to an e-learning platform with 12 nutrition and wellness video content sessions, a Fitbit Charge 5, and daily SMS text messages grounded in the self-determination theory to promote physical activity. Youth in the standard control group will receive information on diet and physical activity guidelines and guidance on setting behavior change goals. The #Study findings will focus on the evaluation of feasibility criteria: (1) recruitment of 40 Hispanic adolescents aged 12 to 16 years; (2) retention of 80% of the participants for postassessments; (3) integrity of the #Study #Protocol, defined as 70% or higher completion of content sessions and Fitbit wear on 5 days per week or more with response to 80% of SMS text messages when prompted; (4) 10% or lower incidence of technical issues; and (5) 80% or higher satisfaction among participants. Results: This #Study was funded in August 2022 and intervention implementation is ongoing. To date, 35 participants have been enrolled. #Study findings will be available before December 2026 and will focus on an evaluation of the a priori feasibility criteria on participant recruitment, data collection, integrity of the #Study #Protocol, technical issues, and satisfaction. #Study findings will also focus on secondary outcomes. Conclusions: The feasibility and process evaluation data obtained from this #Study will provide novel insights on the use of #Digital T2D prevention strategies among Hispanic youth and families and will inform the development of future #Digital health interventions among high-risk pediatric populations. Trial Registration: ClinicalTrials.gov NCT06943001; https://clinicaltrials.gov/#Study/NCT06943001 International Registered Report Identifier (IRRID): PRR1-10.2196/75331

JMIR Res Protocols: A #Digital #Diabetes Prevention Program for Hispanic Adolescents (Fit24+): #Protocol for a Feasibility #RCT #ClinicalTrial

Kudos to Aultman Health Foundation for enrolling their first patient in #RealWorldData #PatientRegistry PrE1702! This study is evaluating how well osimertinib +/- chemo/IO works to control EGFR+ #LungCancer in patients not in a #ClinicalTrial. bit.ly/pre1702-study

Effectiveness of StriveWeekly, a Preventive #Digital #MentalHealth Intervention for University Students: Replication #RCT #ClinicalTrial Date Submitted: Dec 18, 2025. Open Peer Review Period: Apr 14, 2026 - Jun 9, 2026.

Effectiveness of StriveWeekly, a Preventive #Digital #MentalHealth Intervention for University Students: Replication #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

THIS MONTH: Drive your #clinicaltrial forward with confidence!

@biorasi.bsky.social is back in Burlingame this month for #CTOW West Coast 2026. We'll be at Booth 17A, and there's still time to schedule a 1-on-1 at >> bit.ly/biorasi-contact

#Biorasi2026 #confidentclinicaltrials #biotech

FDA renews criticism of trial sponsors over transparency The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.

The #FDA has launched a drive to get #clinicaltrial sponsors to disclose the #results of studies – even if they are negative – saying around a third of them are going unreported.

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial

This phase 2/3 #ClinicalTrial demonstrates that combining #Finotonlimab with #Bevacizumab significantly improves clinical outcomes for advanced #HepatocellularCarcinoma, providing a high-efficacy first-line therapeutic strategy.

#STTT #OpenAccess: doi.org/10.1038/s413...

Effect of a #Health Belief Model–Based Motor-Cognitive Dual-Task Intervention on Functional Improvement in Older Adults with Cognitive Frailty: A #RCT #ClinicalTrial Date Submitted: Apr 9, 2026. Open Peer Review Period: Apr 9, 2026 - Jun 4, 2026.

Reminder>> Effect of a #Health Belief Model–Based Motor-Cognitive Dual-Task Intervention on Functional Improvement in Older Adults with Cognitive Frailty: A #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

Augmented Reality-Based Rapid Blood Transfusion Device Training for Emergency Nurses: #RCT #ClinicalTrial Date Submitted: Apr 13, 2026. Open Peer Review Period: Apr 13, 2026 - Jun 8, 2026.

Augmented Reality-Based Rapid Blood Transfusion Device Training for Emergency Nurses: #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

Feasibility of Internet-Based Mind-Body Training for Adults With Subjective Cognitive Decline: #Protocol for a #RCT #ClinicalTrial Background: In the United States, the prevalence of Alzheimer disease (AD) is projected to double over the next 30 years, with associated familial and societal costs estimated at US $1 trillion annually if current trends continue. Although pharmacological treatments of AD are showing promise, the adoption of healthy lifestyle behaviors, particularly during the preclinical phase of AD, may reduce dementia rates by up to 45%. Subjective cognitive decline (SCD), defined as persistent self-perceived declines in cognitive functioning compared with previously normal cognitive abilities, has been identified as a potential preclinical stage of AD. Objective: This #RCT #ClinicalTrial aims to evaluate the feasibility and acceptability of an internet-based, asynchronous mindfulness-based stress reduction program compared with an active control group (an internet-based lifestyle education program). Secondary objectives include examining preliminary effects of each intervention on SCD, plasma-based biomarkers of amyloid and tau pathology, and everyday mind-wandering. Methods: Sixty adults aged 50 years and older will be screened for SCD in the absence of objective cognitive impairment, based on the Uniform Data Set Neuropsychological Battery (version 3.0) from the National Alzheimer’s Coordinating Center. Eligible and consenting participants will complete behavioral and imaging-based tasks of sustained attention and mind-wandering, as well as blood draws at baseline and after the 8-week intervention. After baseline assessments, participants will be randomized to either an internet-based, asynchronous mindfulness-based stress reduction program or the internet-based lifestyle education program. Both programs have been adapted from our manualized in-person programs and refined through focus group interviews with the target population. Results: The #Study was funded in April 2024. Phase 1 focused on iterative development of the 2 programs based on focus group feedback. Recruitment for the #RCT #ClinicalTrial (internet-based mind-body training trial) began in June 2025 and is ongoing. Recruitment is expected to conclude in September 2026, with data collection ending in December 2026. Conclusions: Behavioral, lifestyle-based interventions that emphasize experiential practices show promise as preventative strategies to prevent decline in cognitive and brain health. Yet, there remain significant barriers to engaging with in-person programs, including limited accessibility, time and schedule constraints, and travel logistics. The internet-based mind-body training trial will evaluate the feasibility and acceptability of 2 fully online, mind-body training programs for adults at risk for AD. Future Stage II and Stage III studies will be necessary to establish the efficacy of these programs for improving AD biomarkers and cognitive outcomes and their broader dissemination to adults noticing subtle changes in cognitive functioning. Trial Registration: Clinicaltrials.gov NCT07019402; https://clinicaltrials.gov/#Study/NCT07019402 International Registered Report Identifier (IRRID): DERR1-10.2196/86276

JMIR Res Protocols: Feasibility of Internet-Based Mind-Body Training for Adults With Subjective Cognitive Decline: #Protocol for a #RCT #ClinicalTrial

This phase 3 randomized #ClinicalTrial demonstrates that #Penpulimab combined with #Chemotherapy significantly prolongs progression-free survival in recurrent or #Metastatic #NasopharyngealCarcinoma. @fudan-university.bsky.social

#STTT #OpenAccess: doi.org/10.1038/s413...

🚨Spire’s experimental inflammatory bowel drug reduces disease activity in mid-stage trial. #IBD #ClinicalTrial

Effectiveness of Low-Dose Atropine Combined With Bright Light Therapy for Controlling Myopic Eye Growth in Schoolchildren: #Study #Protocol for a #RCT #ClinicalTrial Background: Myopia is increasingly prevalent worldwide, with projections indicating that nearly 50% of the global population may have myopia by 2050. This surge poses significant concerns due to its impact on vision and quality of life and its link to a range of blinding diseases, including myopic macular degeneration, glaucoma, and retinal detachment. Current pharmacologic and optical interventions offer limited effectiveness in slowing myopia progression, highlighting the urgent need for more effective treatments. Objective: This #Study aims to examine the combined effect of bright light therapy and low-dose atropine on myopic progression. Methods: This is a single-site, 2-arm, single-masked (examiner-masked) #RCT #ClinicalTrial to compare the effectiveness of low-dose atropine alone and its combination with bright light therapy in retarding myopia progression. The #Study #Protocol has been approved by the institutional review boards of Hong Kong Polytechnic University (HSEARS 20180829002-05) and the University of Hong Kong and Hospital Authority Hong Kong West Cluster (UW 20-362). Schoolchildren with myopia aged 7 to 12 years who have not undergone any previous myopic control intervention will be recruited and randomly allocated into 2 groups (n=67 per group) after baseline measurements. Both groups will receive 0.01% atropine twice daily for 24 months. The combination treatment group will also receive a high-intensity lamp for bright light therapy. The primary and secondary outcome measures will be the changes in cycloplegic autorefraction in spherical equivalent refraction and axial length, respectively, measured every 6 months over 2 years from baseline. Results: The project was funded in January 2019. The recruitment process started on March 21, 2023, and was completed on February 2, 2024. Data collection is expected to be completed in April 2026. Conclusions: This #Study will provide new information on whether the combination of bright light therapy and low-dose atropine is more effective than atropine alone in slowing down myopia progression. It will also assess the effectiveness of low-dose atropine used twice daily. Combining bright light therapy and atropine could become a new treatment option if shown to be effective. New data on the effectiveness of using atropine twice daily might also expand available treatment options. Trial Registration: ClinicalTrials.gov NCT04923841; https://clinicaltrials.gov/#Study/NCT04923841 International Registered Report Identifier (IRRID): DERR1-10.2196/90893

JMIR Res Protocols: Effectiveness of Low-Dose Atropine Combined With Bright Light Therapy for Controlling Myopic Eye Growth in Schoolchildren: #Study #Protocol for a #RCT #ClinicalTrial

A screenshot of the video premiere of an Illinois Cancer Health Research (I-CHER) Center project.

Our video premiere brought community members together to highlight an I-CHER project raising awareness about #clinicaltrial participation for Black women with #breastcancer.

Watch more: https://bit.ly/4tyL8Kf

🚨 Spyre’s experimental IBD drug reduces disease activity in mid-stage trial #IBD #ClinicalTrial

Effects of a Personalized Retrieval-Augmented Generation Chatbot on Information Needs in Chronic Kidney #Disease #Patients: Mixed Methods #RCT #ClinicalTrial Date Submitted: Apr 7, 2026. Open Peer Review Period: Apr 8, 2026 - Jun 3, 2026.

Reminder>> Effects of a Personalized Retrieval-Augmented Generation Chatbot on Information Needs in Chronic Kidney #Disease #Patients: Mixed Methods #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

A 12-Week #Telerehabilitation-Based Fine Motor Training Program for Children with Inattentive ADHD: #RCT #ClinicalTrial Date Submitted: Apr 6, 2026. Open Peer Review Period: Apr 6, 2026 - Jun 1, 2026.

Reminder>> A 12-Week #Telerehabilitation-Based Fine Motor Training Program for Children with Inattentive ADHD: #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis

This phase II #ClinicalTrial reports that #Camrelizumab + #Apatinib and #Chemotherapy yields high response rates & manageable safety in #TNBC, with #Biomarker analyses enabling prediction & evaluation of treatment efficacy. #Medsky
#STTT #OpenAccess: doi.org/10.1038/s413...

Effect of a #Health Belief Model–Based Motor-Cognitive Dual-Task Intervention on Functional Improvement in Older Adults with Cognitive Frailty: A #RCT #ClinicalTrial Date Submitted: Apr 9, 2026. Open Peer Review Period: Apr 9, 2026 - Jun 4, 2026.

Effect of a #Health Belief Model–Based Motor-Cognitive Dual-Task Intervention on Functional Improvement in Older Adults with Cognitive Frailty: A #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

Attending #AACR26 next week and interested in #RealWorldEvidence and #ClinicalTrial design? Don't miss Session MW04: Clinical Trial Design Workshop chaired by @eaonc.bsky.social Group Co Chair Dr. Peter O'Dwyer
🗓 Apr 17 | 3–4:30 PM | Room 31 #RWE #CancerResearch

Apply for #ClinicalTrial funding in 4 open RFPs. Learn about our new Chicago trials. Read the @chronphilanthropy.bsky.social feature. Meet our April Researcher Spotlight: Dr. Roch Christian Johnson of Université d'Abomey-Calavi in Benin - all in our April newsletter here: bit.ly/4e9gtyA
#Repurposing

Clinical trial shows gene editing works for β-Thalassaemia, too https://arstechni.ca #β-Thalassaemia #clinicaltrial #geneediting #Science #Health #CRISPR

Effects of a Personalized Retrieval-Augmented Generation Chatbot on Information Needs in Chronic Kidney #Disease #Patients: Mixed Methods #RCT #ClinicalTrial Date Submitted: Apr 7, 2026. Open Peer Review Period: Apr 8, 2026 - Jun 3, 2026.

Effects of a Personalized Retrieval-Augmented Generation Chatbot on Information Needs in Chronic Kidney #Disease #Patients: Mixed Methods #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

NEXT WEEK: What challenges are today's #biotech CMOs facing?

@biorasi.bsky.social will be on site next week at #CMO360 to discuss #clinicaltrial solutions and supporting CMOs at every step.

There's still time to set up a meeting with our team! Visit >> bit.ly/biorasi-cont...

Post-discharge nurse-led rehabilitation to improve functional activity and community participation among post-stroke #Patients in Bangladesh: #Protocol for a #RCT #ClinicalTrial Date Submitted: Apr 1, 2026. Open Peer Review Period: Apr 1, 2026 - May 27, 2026.

Reminder>> Post-discharge nurse-led rehabilitation to improve functional activity and community participation among post-stroke #Patients in Bangladesh: #Protocol for a #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

Effectiveness of Ayurvedic Nutritional Supplements and Yoga #Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS #Study): #Study #Protocol for an Open-Label #RCT #ClinicalTrial Background: Acute mountain sickness (AMS) poses a unique and formidable challenge to healthy personnel at high altitudes. Objective: This #RCT #ClinicalTrial (RCT) #Protocol aimed to assess the effectiveness of Ayurvedic nutritional supplements in conjunction with a yoga #Protocol in reducing the incidence and severity of AMS among healthy personnel stationed in the challenging high-altitude landscapes of the western Himalayas. Methods: The proposed open-label, parallel-group RCT was conducted in apparently healthy individuals of any gender aged 18‐50 years. The #Study was conducted at two distinct high-altitude stages within the western Himalayan region: stage I, situated at an elevation ranging from 9000 to 12,000 feet and stage II, spanning 12,000 to 15,000 feet. A total of 1660 participants (n=830 per stage) underwent random assignment in a 1:1 ratio to receive either the existing acclimatization schedule (AS) for high altitude (control group) or the Ayush intervention (Ayush group) in addition to the AS. The participants in the Ayush group received Ayurvedic nutritional supplements, including the Ayur-nutri kit (Ayush poshak yoga, 25 g, and Ayush cardiac care tea, 125 mL), twice daily, along with a yoga #Protocol (60 min daily) for 120 days. The primary outcome was the incidence of AMS, assessed using the 2018 Lake Louise Scoring System, and the proportion of participants with a Lake Louise Scoring System score of 6 or higher during the first 7 days from baseline. The secondary outcome measures included the proportion of participants with thromboembolic events; changes in coagulation and hemostasis activation markers and proinflammatory markers; and changes in self-reported negative emotional states (depression, anxiety, and stress), sleep quality, and overall quality of life (assessed through Depression Anxiety Stress Scale-21 items, Pittsburgh Sleep Quality Index, and 12-item short-form, respectively) on day 60 and day 120 from baseline. Results: The #Study was funded in March 2023. The data collection was completed in December 2023. A total of 1660 participants were enrolled in the #Study. The analysis of the #Study data is in progress. The #Study outcomes are expected to be published by December 2026. Conclusions: This RCT was the first of its kind to explore the potential benefits of using Ayurvedic nutritional supplements and a yoga #Protocol in conjunction with the standard AS to reduce the occurrence and severity of AMS among healthy personnel. The outcomes of this trial can aid in better acclimatization and resilience among healthy personnel at high altitudes. Trial Registration: Clinical Trial Registry of India CTRI/2023/03/051028; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODI3Njg=&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/81567

JMIR Res Protocols: Effectiveness of Ayurvedic Nutritional Supplements and Yoga #Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS #Study): #Study #Protocol for an Open-Label #RCT #ClinicalTrial

🩹 🪽
Another phone doodle + sketch

#clinicaltrial #clinicaltrialgame #clinicaltrialfanart #clinicaltrialrpg #fanart #art #angelmartinez

A 12-Week #Telerehabilitation-Based Fine Motor Training Program for Children with Inattentive ADHD: #RCT #ClinicalTrial Date Submitted: Apr 6, 2026. Open Peer Review Period: Apr 6, 2026 - Jun 1, 2026.

A 12-Week #Telerehabilitation-Based Fine Motor Training Program for Children with Inattentive ADHD: #RCT #ClinicalTrial (preprint) #openscience #PeerReviewMe #PlanP

Phone doodle + sketch
😵‍💫💦
#clinicaltrial #clinicaltrialgame #clinicaltrialfanart #clinicaltrialrpg #fanart #art #leesmith #angelmartinez

Progressive Achilles Loading via Clinician e-Support (PACE): #Protocol for a Dual-Site #RCT #ClinicalTrial Background: Achilles tendinopathy (AT) is a common condition that limits activity participation in both active and sedentary populations. While exercise and education are well-established treatments for AT, information is lacking on the amount of intervention required and the prognostic factors associated with response to noninvasive treatments. Objective: This noninferiority #RCT #ClinicalTrial will determine the efficacy of a single-visit, physical therapist (PT)–initiated rehabilitation program compared to a multivisit, PT-guided telehealth rehabilitation program for AT and will identify early prognostic factors for individuals who experience the greatest improvement in pain and disability by 4 weeks. Methods: In this single-blind, 2-arm, parallel-group trial, 160 individuals with AT will be randomized to either a single-visit PT-initiated rehabilitation program or a multivisit, PT-guided telehealth rehabilitation program. Primary outcomes will be the numeric rating scale for movement pain and the Victorian Institute of Sport Assessment–Achilles score for disability. Secondary outcomes will include measures of tendon health, measures within the psychosocial health domain, and military readiness. Results: This #Research was funded in July 2024. Participant enrollment began in August 2025 and is expected to conclude in 2028. As of January 2026, 15 participants have been enrolled at the University of Iowa Hospitals and Clinics, meeting the recruitment goals. Conclusions: The PACE (Progressive Achilles Loading via Clinician e-Support) trial will identify a rehabilitation program focused on education and exercise for AT that expands access to care and will identify factors that predict responses to exercise and education. Trial Registration: ClinicalTrials.gov NCT06736795; https://clinicaltrials.gov/#Study/NCT06736795 International Registered Report Identifier (IRRID): DERR1-10.2196/90955

JMIR Res Protocols: Progressive Achilles Loading via Clinician e-Support (PACE): #Protocol for a Dual-Site #RCT #ClinicalTrial

Effects of Sitting Baduanjin on #Cancer-Related Fatigue in Patients With Advanced #Cancer: #Protocol for a #RCT #ClinicalTrial Background: Approximately 60% of patients with advanced #Cancer experience the distress of #Cancer-related fatigue (CRF), which significantly worsens their daily function and quality of life. Baduanjin has been regarded as a promising nonpharmacological intervention for alleviating CRF, anxiety, and depression and improving quality of life. Owing to varying degrees of CRF in patients with advanced #Cancer, patients may have insufficient endurance, making it difficult to implement standing Baduanjin. However, relevant evidence on sitting Baduanjin for CRF in patients with advanced #Cancer is lacking. Objective: This #Study aims to design a sitting Baduanjin intervention and explore the efficacy and safety of sitting Baduanjin in reducing CRF among patients with advanced #Cancer. Methods: This #Study will be a single-blind pilot #RCT #ClinicalTrial. Patients with CRF will be enlisted from a tertiary #Cancer hospital in China. The participants (N=98) will be randomly assigned to either a sitting Baduanjin group or a control group at a 1:1 ratio using a block-randomized scheme. The participants in the sitting Baduanjin group will undergo a 16-week sitting Baduanjin intervention in addition to standard care, whereas the participants in the control group will receive standard care in the form of a booklet on the self-management of #Cancer symptoms. CRF will constitute the primary outcome, whereas anxiety, depression, and quality of life will serve as the secondary outcomes. These outcomes will be assessed at baseline (T0), 12 weeks (T1), and 16 weeks (T2). Results: The #Study was approved by the Medical Ethics Review Committee of Hunan #Cancer Hospital in March 2024 (ethics approval number 2024.50). Before this full-scale #RCT #ClinicalTrial, we conducted a pilot #Study, which demonstrated the feasibility and acceptability of sitting Baduanjin for patients with advanced #Cancer, with potential benefits for relieving fatigue. Conclusions: This randomized trial will evaluate the effectiveness of sitting Baduanjin exercises in alleviating CRF among patients with advanced #Cancer. If proven effective, it will provide a promising alternative intervention for patients with advanced #Cancer. Trial Registration: Chinese Clinical Trial Register ChiCTR-2400092148; https://www.chictr.org.cn/showproj.html?proj=242990 International Registered Report Identifier (IRRID): IRRID: DERR1-10.2196/84925

JMIR Res Protocols: Effects of Sitting Baduanjin on #Cancer-Related Fatigue in Patients With Advanced #Cancer: #Protocol for a #RCT #ClinicalTrial