scholarly journals Safety of rFVIIa in hemodynamically unstable polytrauma patients with traumatic brain injury: post hoc analysis of 30 patients from a prospective, randomized, placebo-controlled, double-blind clinical trial

Critical Care ◽  
2007 ◽  
Vol 11 (4) ◽  
pp. R85 ◽  
Author(s):  
Yoram Kluger ◽  
Bruno Riou ◽  
Rolf Rossaint ◽  
Sandro B Rizoli ◽  
Kenneth Boffard ◽  
...  
2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Sara Assecondi ◽  
Rong Hu ◽  
Gail Eskes ◽  
Michelle Read ◽  
Chris Griffiths ◽  
...  

Following publication of the original article [1], the authors flagged that the article had published with the Acknowledgements erroneously excluded from the declarations at the end of the article.


2017 ◽  
Vol 83 (3) ◽  
pp. 449-456 ◽  
Author(s):  
Markus B. Skrifvars ◽  
Michael Bailey ◽  
Craig French ◽  
Jeffrey Presneill ◽  
Alistair Nichol ◽  
...  

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Markus B. Skrifvars ◽  
Michael Bailey ◽  
Elizabeth Moore ◽  
Johan Mårtensson ◽  
Craig French ◽  
...  

2020 ◽  
Vol 11 ◽  
Author(s):  
Priscila Aparecida Rodrigues ◽  
Ana Luiza Zaninotto ◽  
Hayden M. Ventresca ◽  
Iuri Santana Neville ◽  
Cintya Yukie Hayashi ◽  
...  

Background: Traumatic brain injury (TBI) is one of the leading causes of neuropsychiatric disorders in young adults. Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to improve psychiatric symptoms in other neurologic disorders, such as focal epilepsy, Parkinson's disease, and fibromyalgia. However, the efficacy of rTMS as a treatment for anxiety in persons with TBI has never been investigated. This exploratory post-hoc analyzes the effects of rTMS on anxiety, depression and executive function in participants with moderate to severe chronic TBI.Methods: Thirty-six participants with moderate to severe TBI and anxiety symptoms were randomly assigned to an active or sham rTMS condition in a 1:1 ratio. A 10-session protocol was used with 10-Hz rTMS stimulation over the left dorsolateral prefrontal cortex (DLPFC) for 20 min each session, a total of 2,000 pulses were applied at each daily session (40 stimuli/train, 50 trains). Anxiety symptoms; depression and executive function were analyzed at baseline, after the last rTMS session, and 90 days post intervention.Results: Twenty-seven participants completed the entire protocol and were included in the post-hoc analysis. Statistical analysis showed no interaction of group and time (p > 0.05) on anxiety scores. Both groups improved depressive and executive functions over time, without time and group interaction (ps < 0.05). No adverse effects were reported in either intervention group.Conclusion: rTMS did not improve anxiety symptoms following high frequency rTMS in persons with moderate to severe TBI.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02167971.


Brain Injury ◽  
2018 ◽  
Vol 32 (8) ◽  
pp. 1050-1055 ◽  
Author(s):  
Hossein Ghalaenovi ◽  
Arash Fattahi ◽  
Jalil Koohpayehzadeh ◽  
Mahmoud Khodadost ◽  
Neda Fatahi ◽  
...  

2014 ◽  
Vol 10 (5) ◽  
pp. 311 ◽  
Author(s):  
Srinivas Nalamachu, MD ◽  
Martin Hale, MD ◽  
Arif Khan, MD

Objective: The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release (ER) in patients with chronic low back pain (LBP) with or without a neuropathic component.Design: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled clinical trial using a randomized withdrawal design, performed in patients with moderate to severe chronic LBP. Patients achieving stable doses of hydromorphone ER during a 2- to 4-week conversion and titration phase were randomized to continue treatment with hydromorphone ER or taper-down to placebo during a 12-week double-blind phase. The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale (NRS) pain intensity score from randomization to the final visit of the double-blind phase. Tolerability was assessed by recording adverse events (AEs). Data were analyzed separately for patients with non-neuropathic and neuropathic LBP.Results: A total of 173 patients with non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into the double-blind phase. During the conversion and titration phase, mean (SD) NRS scores decreased significantly from 6.5 (1.87) and 6.4 (1.99) at screening to 3.3 (0.98) and 3.2 (1.05), respectively. For both LBP subgroups, patients randomized to hydromorphone ER maintained this improvement over the double-blind treatment period, whereas those randomized to placebo reported significant increase in NRS scores. Across subgroups, the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase.Conclusions: The results of this study indicate that hydromorphone ER is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic LBP.


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