Background: Whether minimally invasive endoscopic surgery (ES) improves survival and functional outcome in people with spontaneous supratentorial intracerebral hemorrhage (SSICH) is unknown.
Methods: This is a single-center pilot study performed between July 2021 to January 2023. Any supratentorial hematoma with a volume between 20 mL and 100 mL was endoscopically evacuated within 24 h after bleeding onset.
Objectives: Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency.
Study Design And Setting: In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results.
BMJ Open
May 2022
Objectives: Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist.
View Article and Find Full Text PDFBackground: We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs.
Methods And Findings: We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study.
CNS Neurol Disord Drug Targets
March 2023
Background: Twenty million Americans suffer from peripheral nerve injury (PNI) and approximately $150 billion is spent annually in the United States for the treatment of nerve injuries. Moreover, 50,000 cases of PNI repairs are performed annually in the United States, with even less than 42% experiencing satisfactory sensory recovery. Available therapies control painful symptoms but do not treat axonal degeneration or neuronal cell death.
View Article and Find Full Text PDFImportance: Clinical trial registries are important for gaining an overview of ongoing research efforts and for deterring and identifying publication bias and selective outcome reporting. The reliability of the information in trial registries is uncertain.
Objective: To assess the reliability of information across registries for trials with multiple registrations.
Objectives: To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement.
Methods: We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions.
Trials
October 2020
Background: Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols.
View Article and Find Full Text PDFCNS Neurol Disord Drug Targets
November 2021
The concepts of the neurobiology of nerve injury, fibrosis and regeneration are critical. Millions of people worldwide are affected every year by traumatic and non-traumatic forms of injury to the spinal cord or the peripheral nerves that cause huge socioeconomic burdens. Innumerable studies over the last few decades have studied the disease pathogenesis.
View Article and Find Full Text PDFConstitutive JAK2 signaling is central to myeloproliferative neoplasm (MPN) pathogenesis and results in activation of STAT, PI3K/AKT, and MEK/ERK signaling. However, the therapeutic efficacy of current JAK2 inhibitors is limited. We investigated the role of MEK/ERK signaling in MPN cell survival in the setting of JAK inhibition.
View Article and Find Full Text PDFBiochem Biophys Res Commun
February 2016
Hypoxia promotes cancer progression, and metastasis. The major protein expressed in hypoxic solid cancer is hypoxia-inducible factor 1 (HIF1). We show that enhanced phosphorylation of a conventional protein kinase C isoform, PKCα, at threonine 638 (T(638)) by hypoxia-mimetic cobalt chloride induces HIF1α in nuclei of gastric epithelial cells (GECs).
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