Articles with "analysis plan" as a keyword



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Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow up? Statistical analysis plan for the MEL-SELF randomised controlled trial.

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Published in 2022 at "Contemporary clinical trials"

DOI: 10.1016/j.cct.2022.106761

Abstract: BACKGROUND The MEL-SELF trial is a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised cutaneous melanoma (stage 0, I, II). The primary trial aim is to determine if… read more here.

Keywords: led surveillance; analysis plan; statistical analysis; trial ... See more keywords

Protocol and statistical analysis plan for the Antibiotic Choice On ReNal outcomes (ACORN) randomised clinical trial

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Published in 2022 at "BMJ Open"

DOI: 10.1136/bmjopen-2022-066995

Abstract: Introduction Antibiotics are time-critical in the management of sepsis. When infectious organisms are unknown, patients are treated with empiric antibiotics to include coverage for gram-negative organisms, such as antipseudomonal cephalosporins and penicillins. However, in observational… read more here.

Keywords: choice renal; analysis plan; trial; renal outcomes ... See more keywords

PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial

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Published in 2017 at "Trials"

DOI: 10.1186/s13063-017-2203-1

Abstract: BackgroundEffective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen. This paper describes in detail the… read more here.

Keywords: trial; four group; analysis; statistical analysis ... See more keywords
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A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial

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Published in 2020 at "Trials"

DOI: 10.1186/s13063-020-4103-z

Abstract: Background Current treatment options for Palmoplantar Pustulosis (PPP), a debilitating chronic skin disease which affects the hands and feet, are limited. The Anakinra for Pustular psoriasis: Response in a Controlled Trial (APRICOT) aims to determine… read more here.

Keywords: trial; analysis; statistical analysis; controlled trial ... See more keywords
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The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan

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Published in 2020 at "F1000Research"

DOI: 10.12688/f1000research.23383.1

Abstract: Background : The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3… read more here.

Keywords: iron; trial; statistical analysis; analysis plan ... See more keywords

A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial

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Published in 2021 at "Wellcome Open Research"

DOI: 10.12688/wellcomeopenres.17154.1

Abstract: TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the… read more here.

Keywords: clinical trial; analysis plan; trial; act hiv ... See more keywords
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Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study

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Published in 2022 at "Frontiers in Neurology"

DOI: 10.3389/fneur.2022.799531

Abstract: Introduction Optimise:MS is an observational pharmacovigilance study aimed at characterizing the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in a real world population. The study will categorize and quantify the occurrence of… read more here.

Keywords: treatment; analysis plan; study; real world ... See more keywords

Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial

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Published in 2018 at "Revista Brasileira de Terapia Intensiva"

DOI: 10.5935/0103-507x.20180041

Abstract: Background ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated… read more here.

Keywords: andromeda shock; trial; analysis; statistical analysis ... See more keywords

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS)

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Published in 2020 at "Revista Brasileira de Terapia Intensiva"

DOI: 10.5935/0103-507x.20200081

Abstract: Objective To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Methods BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of… read more here.

Keywords: versus saline; study; analysis plan; statistical analysis ... See more keywords