Articles: covid-19.
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Randomized Controlled Trial
Surgical masks and filtering facepiece class 2 respirators (FFP2) have no major physiological effects at rest and during moderate exercise at 3000 m altitude. A randomised controlled trial.
During the COVID-19 pandemic, the use of face masks has been recommended or enforced in several situations; however, their effects on physiological parameters and cognitive performance at high altitude are unknown. ⋯ Although mask use was associated with higher rates of dyspnoea, it had no clinically relevant impact on gas exchange at 3000 m at rest and during moderate exercise, and no detectable effect on resting cognitive performance. Wearing a surgical mask or an FFP2 can be considered safe for healthy people living, working or spending their leisure time in mountains, high-altitude cities or other hypobaric environments (e.g. aircrafts) up to an altitude of 3000 m.
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Journal of neurotrauma · Sep 2023
Randomized Controlled Trial Multicenter StudySafety and Efficacy of Riluzole in Acute Spinal Cord Injury (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.
Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. ⋯ However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.
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Randomized Controlled Trial Multicenter Study
FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial.
Vascular leakage is a major feature of acute respiratory distress syndrome (ARDS). We aimed to evaluate the efficacy of FX06, a drug under development that stabilizes interendothelial cell junctions, at reducing vascular leakage during SARS-CoV-2-induced ARDS. ⋯ In this unique-dosing-regimen study, FX06 did not lower SARS-CoV-2-induced pulmonary vascular leakage. Future investigations will need to evaluate its efficacy at earlier times during the disease or using other regimens. Trial registration NCT04618042. Registered 5 November 2020.
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Randomized Controlled Trial
Safety and efficacy of 5-aminolevulinic acid phosphate/iron in mild-to-moderate coronavirus disease 2019: A randomized exploratory phase II trial.
5-aminolevulinic acid (5-ALA), a natural amino acid that is marketed alongside sodium ferrous citrate (SFC) as a functional food, blocks severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) proliferation in vitro and exerts anti-inflammatory effects. In this phase II open-label, prospective, parallel-group, randomized trial, we aimed to evaluate the safety and efficacy of 5-ALA in patients with mild-to-moderate coronavirus disease 2019. ⋯ 5-ALA/SFC improved some symptoms but did not influence the SARS-CoV-2 viral load or clinical symptom scores over 14 days. The safety of 5-ALA/SFC in this study was acceptable. Further evaluation using a larger sample size or modified method is warranted.
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Intensive care medicine · Aug 2023
Randomized Controlled TrialSafety and efficacy of artesunate treatment in severely injured patients with traumatic hemorrhage. The TOP-ART randomized clinical trial.
This study aimed at determining whether intravenous artesunate is safe and effective in reducing multiple organ dysfunction syndrome in trauma patients with major hemorrhage. ⋯ Among critically ill trauma patients, artesunate is unlikely to improve organ dysfunction and might be associated with a higher VTE rate.