The use of healthcare systems data for RCTs
ConclusionsHSD is being used in around two thirds of the studies but cannot yet be used to support PRO data collection within the cohort we examined. Comparison with an earlier cohort demonstrates an increase in the number of RCTs planning to use HSD. (Source: Trials)
Source: Trials - January 29, 2024 Category: Research Source Type: clinical trials
PLUS-IS-LESS project: Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments: study protocol for a pragmatic stepped-wedge cluster-randomized trial
This study was registered on July 19, 2022, on the ClinicalTrials.gov registry using reference number: NCT05463406.Trial statusRecruitment started on December 5, 2022, and will be completed on November 3, 2024. Current protocol version is version 3.0, dated April 3, 2023. (Source: Trials)
Source: Trials - January 25, 2024 Category: Research Source Type: clinical trials
Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
DiscussionThe statistical analysis for the ALBINO study was defined in detail in the study protocol and implemented in this statistical analysis plan published prior to any data analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines.Trial registrationClinicalTrials.gov NCT03162653. Registered on 22 May 2017. (Source: Trials)
Source: Trials - January 24, 2024 Category: Research Source Type: clinical trials
Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician ’s perspective
ConclusionThe statistical methodologies implemented in ComFluCOV helped to deliver the study in the timescale set. Working in a new clinical area to tight timescales was challenging. Having two statisticians working together on the study provided a quality assurance process that enabled analyses to be completed efficiently and ensured data were interpreted correctly. Processes developed could be applied to other studies to maximise quality, reduce the risk of errors, and overall provide enhanced validation methods.Trial registrationISRCTN14391248, registered on 30 March 2021 (Source: Trials)
Source: Trials - January 23, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial
ConclusionsThis statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke.Trial registrationClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018.SAP version1.13 (October 12 2023)Protocol version1.12 (October 12, 2022)SAP revisionsNil (Source: Trials)
Source: Trials - January 23, 2024 Category: Research Source Type: clinical trials
Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9 —Pragmatic Research and Innovation through Multinational Experimentation
AbstractIn an era focused on value-based healthcare, the quality of healthcare and resource allocation should be underpinned by empirical evidence. Pragmatic clinical trials (pRCTs) are essential in this endeavor, providing randomized controlled trial (RCT) insights that encapsulate real-world effects of interventions. The rising popularity of pRCTs can be attributed to their ability to mirror real-world practices, accommodate larger sample sizes, and provide cost advantages over traditional RCTs. By harmonizing efficacy with effectiveness, pRCTs assist decision-makers in prioritizing interventions that have a substantial ...
Source: Trials - January 23, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)
This article describes the detailed statistical analysis plan for the trial.Methods and designiCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to...
Source: Trials - January 17, 2024 Category: Research Source Type: clinical trials
Initial treatment with a single capsule containing half-dose quadruple therapy versus standard-dose dual therapy in hypertensive patients (QUADUAL): statistical analysis plan for a randomized, blinded, crossover trial
DiscussionThis statistical analysis plan will be confirmed prior to blind review and data lock before un-blinding and is sought to increase the validity of the QUADUAL trial.Trial registrationClinicalTrials.gov, NCT05377203. Registered May 11, 2022,https://clinicaltrials.gov/study/NCT05377203. (Source: Trials)
Source: Trials - January 13, 2024 Category: Research Source Type: clinical trials
Precutting endoscopic band ligation-assisted resection versus endoscopic submucosal dissection in patients with small gastric submucosal tumors originating from the muscularis propria: study protocol of a randomized controlled trial
This study was designed to validate the feasibility of a novel operation for removing gastric SMT-MPs. To intuitively assess this phenomenon, the operation durations of precutting EBLR and ESD were compared, and other outcomes were also recorded comprehensively.Trial registrationChinese Clinical Trial RegistryChiCTR2200065473. Registered on November 5, 2022. (Source: Trials)
Source: Trials - January 13, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)
DiscussionThis will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.Trial registrationThe trial is registered as NCT05225961. February, 7th, 2022. (Source: Trials)
Source: Trials - January 9, 2024 Category: Research Source Type: clinical trials
Update of statistical analysis plan for: Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)
AbstractThis protocol paper presents an updated statistical analysis plan of the protocol of a randomised controlled trial. The randomised controlled trial investigates the effect of integrating smoking cessation interventions at outpatient opioid agonist therapy (OAT) clinics for persons with opioid dependency receiving OAT medication. The intervention group receives weekly follow-up including a short behavioural intervention and provision of nicotine replacement products. The control group receives standard treatment. The duration of the intervention is 16 weeks and the follow-up was completed by the end of October 2023....
Source: Trials - January 6, 2024 Category: Research Source Type: clinical trials
Oryzon Announces Topline Results from Phase IIb PORTICO study of Vafidemstat in Borderline Personality Disorder (BPD)
Results across all efficacy endpoints consistently favored vafidemstat over placebo. Global Statistical Test (GST p-values) confirms consistent trend across efficacy endpoints
The primary endpoints, improvement in Borderline Personality Disorder... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 5, 2024 Category: Pharmaceuticals Source Type: clinical trials
A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel to treat human keloids: a trial protocol
This study examines the efficacy of 5% losartan potassium loaded in ethosomal gel for human keloids.Trial registrationClinicaltrial.gov identifierNCT05893108. Registered on 7 June 2023. (Source: Trials)
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials
Efficacy and safety of heparin for sepsis-induced disseminated intravascular coagulation (HepSIC): study protocol for a multicenter randomized controlled trial
DiscussionThe HepSIC trial is to evaluate the efficacy and safety of UFH on sepsis-related DIC across different areas of China. The small dosage of UFH administration would offer a new potential approach for treating sepsis-related coagulation disorders.Ethics and disseminationEthical approval was granted by all the ethics committees of 20 participant centers. Results will be disseminated via peer-reviewed publications and presented at conferences.Trial registrationClinicalTrials.gov NCT02654561. Registered on 13 January 2016. (Source: Trials)
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials
Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia
Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005)
All six key secondary endpoints, including patient global impression, fibromyalgia-specific symptoms and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 20, 2023 Category: Pharmaceuticals Source Type: clinical trials
