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  1. Article ; Online: Monitoring patients with severe traumatic brain injury.

    Diaz-Arrastia, Ramon / Bernard, Francis / Shutter, Lori / Barsan, William / Silbergleit, Robert

    The Lancet. Neurology

    2024  Volume 23, Issue 3, Page(s) 230–231

    MeSH term(s) Humans ; Brain Injuries, Traumatic ; Brain Injuries ; Monitoring, Physiologic
    Language English
    Publishing date 2024-01-25
    Publishing country England
    Document type Letter
    ZDB-ID 2081241-3
    ISSN 1474-4465 ; 1474-4422
    ISSN (online) 1474-4465
    ISSN 1474-4422
    DOI 10.1016/S1474-4422(24)00023-1
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  2. Article ; Online: Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3): a multicentre, randomised, blinded-endpoint, comparative effectiveness study of brain tissue oxygen and intracranial pressure monitoring versus intracranial pressure alone.

    Bernard, Francis / Barsan, William / Diaz-Arrastia, Ramon / Merck, Lisa H / Yeatts, Sharon / Shutter, Lori A

    BMJ open

    2022  Volume 12, Issue 3, Page(s) e060188

    Abstract: Introduction: Management of traumatic brain injury (TBI) includes invasive monitoring to prevent secondary brain injuries. Intracranial pressure (ICP) monitor is the main measurement used to that intent but cerebral hypoxia can occur despite normal ICP. ...

    Abstract Introduction: Management of traumatic brain injury (TBI) includes invasive monitoring to prevent secondary brain injuries. Intracranial pressure (ICP) monitor is the main measurement used to that intent but cerebral hypoxia can occur despite normal ICP. This study will assess whether the addition of a brain tissue oxygenation (PbtO
    Methods and analysis: Multicentre, randomised, blinded-endpoint comparative effectiveness study enrolling 1094 patients with severe TBI monitored with both ICP and PbtO
    Ethics and dissemination: This has been approved by Advarra Ethics Committee (Pro00030585). Results will be presented at scientific meetings and published in peer-reviewed publications.
    Trial registration number: ClinicalTrials.gov Registry (NCT03754114).
    MeSH term(s) Brain ; Brain Injuries, Traumatic/therapy ; Humans ; Intracranial Pressure ; Oxygen ; Quality of Life
    Chemical Substances Oxygen (S88TT14065)
    Language English
    Publishing date 2022-03-10
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-060188
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  3. Book: Emergency drug therapy

    Barsan, William G. / Jastremski, Michael S. / Syverud, Scott A.

    1991  

    Author's details William G. Barsan ; Michael S. Jastremski ; Scott A. Syverud
    Keywords Drug Therapy ; Emergencies ; Notfallmedizin ; Pharmakotherapie
    Subject Arzneimitteltherapie ; Arzneitherapie ; Medikamentöse Therapie ; Internistische Notfallmedizin
    Size XV, 655 S. : graph. Darst.
    Edition 1. print
    Publisher Saunders
    Publishing place Philadelphia u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT003769003
    ISBN 0-7216-2584-3 ; 978-0-7216-2584-3
    Database Catalogue ZB MED Medicine, Health

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    1991 A 1992 order for loan Magazin

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  4. Article ; Online: Comparison of Bayesian vs Frequentist Adaptive Trial Design in the Stroke Hyperglycemia Insulin Network Effort Trial.

    Broglio, Kristine / Meurer, William J / Durkalski, Valerie / Pauls, Qi / Connor, Jason / Berry, Donald / Lewis, Roger J / Johnston, Karen C / Barsan, William G

    JAMA network open

    2022  Volume 5, Issue 5, Page(s) e2211616

    Abstract: Importance: Bayesian adaptive trial design has the potential to create more efficient clinical trials. However, a barrier to the uptake of bayesian adaptive designs for confirmatory trials is limited experience with how they may perform compared with a ... ...

    Abstract Importance: Bayesian adaptive trial design has the potential to create more efficient clinical trials. However, a barrier to the uptake of bayesian adaptive designs for confirmatory trials is limited experience with how they may perform compared with a frequentist design.
    Objective: To compare the performance of a bayesian and a frequentist adaptive clinical trial design.
    Design, setting, and participants: This prospective cohort study compared 2 trial designs for a completed multicenter acute stroke trial conducted within a National Institutes of Health neurologic emergencies clinical trials network, with individual patient-level data, including the timing and order of enrollments and outcome ascertainment, from 1151 patients with acute stroke and hyperglycemia randomized to receive intensive or standard insulin therapy. The implemented frequentist design had group sequential boundaries for efficacy and futility interim analyses at 90 days after randomization for 500, 700, 900, and 1100 patients. The bayesian alternative used predictive probability of trial success to govern early termination for efficacy and futility with a first interim analysis at 500 randomized patients and subsequent interims after every 100 randomizations.
    Main outcomes and measures: The main outcome was the sample size at end of study, which was defined as the sample size at which each of the studies stopped accrual of patients.
    Results: Data were collected from 1151 patients. As conducted, the frequentist design passed the futility boundary after 936 participants were randomized. Using the same sequence and timing of randomization and outcome data, the bayesian alternative crossed the futility boundary approximately 3 months earlier after 800 participants were randomized.
    Conclusions and relevance: Both trial designs stopped for futility before reaching the planned maximum sample size. In both cases, the clinical community and patients would benefit from learning the answer to the trial's primary question earlier. The common feature across the 2 designs was frequent interim analyses to stop early for efficacy or for futility. Differences between how these analyses were implemented between the 2 trials resulted in the differences in early stopping.
    MeSH term(s) Bayes Theorem ; Humans ; Hyperglycemia/drug therapy ; Insulin/therapeutic use ; Insulin, Regular, Human ; Prospective Studies ; Stroke/drug therapy ; United States
    Chemical Substances Insulin ; Insulin, Regular, Human
    Language English
    Publishing date 2022-05-02
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2022.11616
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  5. Article ; Online: Selection of a statistical analysis method for the Glasgow Outcome Scale-Extended endpoint for estimating the probability of favorable outcome in future severe TBI clinical trials.

    Wang, Yu / Yeatts, Sharon D / Martin, Renee' H / Silbergleit, Robert / Rockswold, Gaylan L / Barsan, William G / Korley, Frederick K / Rockswold, Sarah / Gajewski, Byron J

    Statistics in medicine

    2023  Volume 42, Issue 25, Page(s) 4582–4601

    Abstract: The Glasgow outcome scale-extended (GOS-E), an ordinal scale measure, is often selected as the endpoint for clinical trials of traumatic brain injury (TBI). Traditionally, GOS-E is analyzed as a fixed dichotomy with favorable outcome defined as GOS-E ≥ 5 ...

    Abstract The Glasgow outcome scale-extended (GOS-E), an ordinal scale measure, is often selected as the endpoint for clinical trials of traumatic brain injury (TBI). Traditionally, GOS-E is analyzed as a fixed dichotomy with favorable outcome defined as GOS-E ≥ 5 and unfavorable outcome as GOS-E < 5. More recent studies have defined favorable vs unfavorable outcome utilizing a sliding dichotomy of the GOS-E that defines a favorable outcome as better than a subject's predicted prognosis at baseline. Both dichotomous approaches result in loss of statistical and clinical information. To improve on power, Yeatts et al proposed a sliding scoring of the GOS-E as the distance from the cutoff for favorable/unfavorable outcomes, and therefore used more information found in the original GOS-E to estimate the probability of favorable outcome. We used data from a published TBI trial to explore the ramifications to trial operating characteristics by analyzing the sliding scoring of the GOS-E as either dichotomous, continuous, or ordinal. We illustrated a connection between the ordinal data and time-to-event (TTE) data to allow use of Bayesian software that utilizes TTE-based modeling. The simulation results showed that the continuous method with continuity correction offers higher power and lower mean squared error for estimating the probability of favorable outcome compared to the dichotomous method, and similar power but higher precision compared to the ordinal method. Therefore, we recommended that future severe TBI clinical trials consider analyzing the sliding scoring of the GOS-E endpoint as continuous with continuity correction.
    MeSH term(s) Humans ; Bayes Theorem ; Brain Injuries, Traumatic/therapy ; Glasgow Outcome Scale ; Probability ; Prognosis ; Clinical Trials as Topic
    Language English
    Publishing date 2023-08-20
    Publishing country England
    Document type Journal Article
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.9877
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    Zs.A 1756: Show issues Location:
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  6. Book: Radiology in emergency medicine

    Levy, Richard C. / Hawkins, Hugh / Barsan, William G.

    1986  

    Author's details Richard C. Levy ; Hugh Hawkins ; William G. Barsan
    Keywords Emergencies ; Radiography
    Size XI, 468 S. : überw. Ill.
    Edition 1. [Dr.]
    Publisher Mosby
    Publishing place St. Louis u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT002906956
    ISBN 0-8016-3144-0 ; 978-0-8016-3144-3
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    1987 A 952 order for loan Magazin
    2004 A 7677 order for loan Magazin

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  7. Article ; Online: Coagulation markers and functional outcome in acute ischemic stroke: Impact of intensive versus standard hyperglycemia control.

    Gentile, Nina T / Rao, A Koneti / Reimer, Hannah / Del Carpio-Cano, Fabiola / Ramakrishnan, Viswanathan / Pauls, Qi / Barsan, William G / Bruno, Askiel

    Research and practice in thrombosis and haemostasis

    2021  Volume 5, Issue 5, Page(s) e12563

    Abstract: Objective: Alterations in coagulation could mediate functional outcome in patients with hyperglycemia after acute ischemic stroke (AIS). We prospectively studied the effects of intensive versus standard glucose control on coagulation markers and their ... ...

    Abstract Objective: Alterations in coagulation could mediate functional outcome in patients with hyperglycemia after acute ischemic stroke (AIS). We prospectively studied the effects of intensive versus standard glucose control on coagulation markers and their relationships to functional outcomes in patients with AIS.
    Approach: The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial measured the coagulation biomarkers whole blood tissue factor procoagulant activity (TFPCA); plasma factors VII (FVII), VIIa (FVIIa), and VIII (FVIII); thrombin-antithrombin (TAT) complex; D-dimer; tissue factor pathway inhibitor, and plasminogen activator inhibitor-1 (PAI-1) antigen in patients enrolled in the Stroke Hyperglycemia Insulin Network Effort trial of intensive versus standard glucose control on functional outcome at 3 months after AIS. Changes in biomarkers over time (from baseline ≈12 hours after stroke onset) to 48 hours, and changes in biomarkers between treatment groups, functional outcomes, and their interaction were analyzed by two-way analysis of variance.
    Results: A total of 125 patients were included (57 in the intensive treatment group and 68 in the standard treatment group). The overall mean age was 66 years; 42% were women. Changes from baseline to 48 hours in coagulation markers were significantly different between treatment groups for TFPCA (
    Conclusions: Intensive glucose control induced greater alterations in coagulation biomarkers than standard treatment, and these were associated with a favorable functional outcome at 3 months after AIS.
    Language English
    Publishing date 2021-07-14
    Publishing country United States
    Document type Journal Article
    ISSN 2475-0379
    ISSN (online) 2475-0379
    DOI 10.1002/rth2.12563
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  8. Article ; Online: Spinal cord injury neuroprotection and the promise of flexible adaptive clinical trials.

    Meurer, William J / Barsan, William G

    World neurosurgery

    2013  Volume 82, Issue 3-4, Page(s) e541–6

    Abstract: Effective treatments for acute neurologic illness and injury are lacking, particularly for spinal cord injury (SCI). The very structure of clinical trials may be contributing to this because assumptions made during trial planning preclude additional ... ...

    Abstract Effective treatments for acute neurologic illness and injury are lacking, particularly for spinal cord injury (SCI). The very structure of clinical trials may be contributing to this because assumptions made during trial planning preclude additional learning within residual important areas of uncertainty, such as dose, timing, and duration of treatment. Adaptive clinical trials offer potential solutions to some of the factors that may be slowing the pace of discovery. Broadly defined, one can consider an adaptive clinical trial as any sort of clinical trial that makes use of information from within the trial to make decisions about how the trial is conducted going forward; however, it is important to emphasize that regardless of the degree of flexibility or complexity of an adaptive clinical trial design, the types of designs being described are only those in which all potential changes to the conduct of the trial are prospectively defined before the first patient is enrolled. Within this review, we describe the structure of flexible adaptive clinical trial designs, the process by which they are developed and conducted, and potential opportunities and drawbacks of these approaches. We must accept that there are some uncertainties that remain when both exploratory and confirmatory trials are designed. The process by which teams carefully consider which uncertainties are most important and most likely to potentially compromise the ability to detect an effective treatment can lead to trial designs that are more likely to find the right treatment for the right population of patients.
    MeSH term(s) Clinical Trials as Topic ; Humans ; Hypothermia, Induced ; Neuroprotective Agents/therapeutic use ; Research Design ; Spinal Cord Injuries/drug therapy ; Spinal Cord Injuries/surgery ; Spinal Cord Injuries/therapy
    Chemical Substances Neuroprotective Agents
    Language English
    Publishing date 2013-07-09
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 2534351-8
    ISSN 1878-8769 ; 1878-8750
    ISSN (online) 1878-8769
    ISSN 1878-8750
    DOI 10.1016/j.wneu.2013.06.017
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    Zs.A 1159: Show issues Location:
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  9. Article ; Online: Impact of regional pre-hospital emergency medical services in treatment of patients with acute ischemic stroke.

    Sozener, Cemal B / Barsan, William G

    Annals of the New York Academy of Sciences

    2012  Volume 1268, Page(s) 51–56

    Abstract: Stroke is a major public health concern afflicting an estimated 795,000 Americans annually. The associated morbidity and mortality is staggering. Early treatment with thrombolytics is beneficial. The window for treatment is narrow and minimization of the ...

    Abstract Stroke is a major public health concern afflicting an estimated 795,000 Americans annually. The associated morbidity and mortality is staggering. Early treatment with thrombolytics is beneficial. The window for treatment is narrow and minimization of the time from symptom onset to treatment is vital. The general population is not well informed as to the warning signs or symptoms of stroke, leading to substantial delays in emergency medical services (EMS) activation. Ambulance transport of stroke patients to the hospital has demonstrated improvements in key benchmarks such as door to physician evaluation, door to CT initiation, and increased thrombolytic treatment. Pre-hospital notification of the impending arrival of a stroke patient allows for vital preparation in the treating emergency department, and improving timely evaluation and treatment upon arrival of the stroke patient. EMS systems are a vital component of the management of stroke patients, and resources used to improve these systems are beneficial.
    MeSH term(s) Acute Disease ; Air Ambulances ; Ambulances ; Brain Ischemia/diagnosis ; Brain Ischemia/drug therapy ; Brain Ischemia/epidemiology ; Brain Ischemia/therapy ; Cerebral Hemorrhage/epidemiology ; Cerebral Hemorrhage/etiology ; Emergency Medical Service Communication Systems ; Emergency Medical Services/methods ; Emergency Medical Services/organization & administration ; Emergency Medical Services/statistics & numerical data ; Emergency Medical Services/trends ; Emergency Service, Hospital/organization & administration ; Emergency Service, Hospital/utilization ; Follow-Up Studies ; Health Services Accessibility ; Humans ; Patient Acceptance of Health Care ; Recombinant Proteins/therapeutic use ; Thrombolytic Therapy ; Time Factors ; Tissue Plasminogen Activator/therapeutic use ; Transportation of Patients/methods ; Treatment Outcome ; United States/epidemiology
    Chemical Substances Recombinant Proteins ; Tissue Plasminogen Activator (EC 3.4.21.68)
    Language English
    Publishing date 2012-09
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 211003-9
    ISSN 1749-6632 ; 0077-8923
    ISSN (online) 1749-6632
    ISSN 0077-8923
    DOI 10.1111/j.1749-6632.2012.06746.x
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    Se 110: Show issues Location:
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  10. Article ; Online: Statistical assessment of the prognostic and the predictive value of biomarkers-A biomarker assessment framework with applications to traumatic brain injury biomarker studies.

    Bantis, Leonidas E / Young, Kate J / Tsimikas, John V / Mosier, Brian R / Gajewski, Byron / Yeatts, Sharon / Martin, Renee L / Barsan, William / Silbergleit, Robert / Rockswold, Gaylan / Korley, Frederick K

    Research methods in medicine & health sciences

    2022  Volume 4, Issue 1, Page(s) 34–48

    Abstract: Studies that investigate the performance of prognostic and predictive biomarkers are commonplace in medicine. Evaluating the performance of biomarkers is challenging in traumatic brain injury (TBI) and other conditions when both the time factor (i.e. ... ...

    Abstract Studies that investigate the performance of prognostic and predictive biomarkers are commonplace in medicine. Evaluating the performance of biomarkers is challenging in traumatic brain injury (TBI) and other conditions when both the time factor (i.e. time from injury to biomarker measurement) and different levels or doses of treatments are in play. Such factors need to be accounted for when assessing the biomarker's performance in relation to a clinical outcome. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial seeks to determine the dose of hyperbaric oxygen therapy (HBOT) for treating severe TBI that has the highest likelihood of demonstrating efficacy in a phase III trial. Hyperbaric Oxygen in Brain Injury Treatment will study up to 200 participants with severe TBI. This paper discusses the statistical approaches to assess the prognostic and predictive performance of the biomarkers studied in this trial, where prognosis refers to the association between a biomarker and the clinical outcome while the predictiveness refers to the ability of the biomarker to identify patient subgroups that benefit from therapy. Analyses based on initial biomarker levels accounting for different levels of HBOT and other baseline clinical characteristics, and analyses of longitudinal changes in biomarker levels are discussed from a statistical point of view. Methods for combining biomarkers that are of complementary nature are also considered and the relevant algorithms are illustrated in detail along with an extensive simulation study that assesses the performance of the statistical methods. Even though the discussed approaches are motivated by the HOBIT trial, their applications are broader. They can be applied in studies assessing the predictiveness and prognostic ability of biomarkers in relation to a well-defined therapeutic intervention and clinical outcome.
    Language English
    Publishing date 2022-12-13
    Publishing country United States
    Document type Journal Article
    ISSN 2632-0843
    ISSN (online) 2632-0843
    DOI 10.1177/26320843221141056
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