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
Effectiveness of full Pulpotomy compared with Root canal treatment in managing teeth with signs and symptOms indicative of irreversible pulpitis: a protocol for prospectiVE meta-analysis of individual participant data of linked randomised clinical trials (PROVE)
DiscussionPMA offers a rigorous, flexible, and efficient methodology to answer this important research question and provide results with improved generalisability and external validity compared with traditional trials and retrospective meta-analyses. The results of this study will have implications for both the delivery of clinical practice and structured clinical guidelines ’ development.Trial registrationPROSPERO CRD42023446809. Registered on 08 February 2023. (Source: Trials)
Source: Trials - December 15, 2023 Category: Research Source Type: clinical trials
NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial
A statistically significant, 37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP) population analysis
Neurofilament biomarker results... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder
Trial met its primary endpoint with MM-120 demonstrating a statistically significant dose-dependent improvement in HAM-A scores four weeks after a single-dose
MM-120 100µg demonstrated a clinically and statistically significant HAM-A... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
REVISE: re-evaluating the inhibition of stress erosions in the ICU —statistical analysis plan for a randomized trial
ConclusionsThis statistical analysis plan outlines the statistical analyses of all outcomes, sensitivity analyses, and subgroup analyses. REVISE will inform clinical practice and guidelines worldwide.Trial registrationwww.ClinicalTrials.gov NCT03374800. November 21, 2017. (Source: Trials)
Source: Trials - December 6, 2023 Category: Research Source Type: clinical trials
A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial
AbstractTheStaphylococcus aureus Network Adaptive Platform (SNAP) trial is a multifactorial Bayesian adaptive platform trial that aims to improve the way thatS. aureus bloodstream infection, a globally common and severe infectious disease, is treated. In a world first, the SNAP trial will simultaneously investigate the effects of multiple intervention modalities within multiple groups of participants with different forms ofS. aureus bloodstream infection. Here, we formalise the trial structure, modelling approach, and decision rules that will be used for the SNAP trial. By summarising the statistical principles governing t...
Source: Trials - December 6, 2023 Category: Research Source Type: clinical trials
A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial
DiscussionThis paper provides a comprehensive description of the statistical analysis plan in order to ensure the reproducibility of the analysis and avoid selective reporting of outcomes and data-driven analysis. Sensitivity analyses have been included in the protocol to assess the impact of intercurrent events related to the coronavirus disease 2019. By focusing on clinically meaningful and robust outcomes, this trial aims to determine whether TUDCA can be effective in slowing the disease progression in patients with ALS.Trial registrationClinicalTrials.govNCT03800524. Registered on January 11, 2019. (Source: Trials)
Source: Trials - December 5, 2023 Category: Research Source Type: clinical trials
How do trial teams plan for retention during the design stage of the trial? A scoping review
ConclusionThere is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct. (Source: Trials)
Source: Trials - December 4, 2023 Category: Research Source Type: clinical trials
Preoperative dexamethasone administration in hepatectomy of 25-min intermittent Pringle ’s maneuver for hepatocellular carcinoma: protocol for a randomized controlled trial
DiscussionBased on our previous study, we will explore further the effect of glucocorticoid administration on attenuating the surgical stress response in order to follow securely 25-min hepatic inflow occlusion. Therefore, the trial protocol is reasonable and the results of the trial may be clinically significant.Trial registrationThis trial was registered on 3 December 2022, in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2200066381. The protocol version is V1.0 (20221104). (Source: Trials)
Source: Trials - November 30, 2023 Category: Research Source Type: clinical trials
Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
AbstractThis manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal...
Source: Trials - November 29, 2023 Category: Research Source Type: clinical trials
The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a statistical analysis plan for a randomized controlled trial
DiscussionThe Promotoer study will provide robust evidence for the short/long-term efficacy of the Promotoer system in subacute stroke patients undergoing a rehabilitation program. Moreover, the development of a predictive score of response will allow transferring of the Promotoer system to optimal clinical practice. By carefully describing the statistical principles and procedures, the statistical analysis plan provides transparency in the analysis of data.Trial registrationClinicalTrials.govNCT04353297. Registered on April 15, 2020. (Source: Trials)
Source: Trials - November 16, 2023 Category: Research Source Type: clinical trials
Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants
DiscussionThis statistical analysis plan presents a secondary Bayesian analysis of the SafeBoosC-III trial. The analysis and the final manuscript will be carried out and written after we publicise the primary frequentist trial report. Thus, we can interpret the findings from both the frequentists and Bayesian perspective. This approach should provide a better foundation for interpreting of our findings.Trial registrationClinicalTrials.org, NCT03770741. Registered on 10 December 2018. (Source: Trials)
Source: Trials - November 16, 2023 Category: Research Source Type: clinical trials
Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1 –11-month-old infants in Mali
ConclusionThe SAP written prior to data collection completion will help avoid reporting bias and data-driven analysis for the primary and secondary aims of the trial. If there are deviations from the analysis methods described here, they will be described and justified in the publications of the trial results.Trial registrationClinicalTrials.gov IDNCT04424511. Registered on 11 June 2020. (Source: Trials)
Source: Trials - November 15, 2023 Category: Research Source Type: clinical trials
Novartis Data Show Potential of Remibrutinib as an Oral Treatment for Chronic Spontaneous Urticaria Providing Significant Symptom Improvement as Early as Week 2
In pivotal Phase III trials, remibrutinib– a highly selective, oral Bruton’s tyrosine kinase inhibitor– demonstrated clinically meaningful and statistically significant reduction in urticaria activity vs placebo1
Treatment... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 9, 2023 Category: Pharmaceuticals Source Type: clinical trials
