scholarly journals Alternative management of Covid-19 infection

2020 ◽  
Vol 65 (3) ◽  
pp. 72-75 ◽  
Author(s):  
Hasan I Atrah
Keyword(s):  
Clinical Trials ◽  
Therapeutic Agents ◽  
High Dose ◽  
Cytokine Storm ◽  
Controlled Clinical Trials ◽  
Safety And Efficacy ◽  
Wide Range ◽  
Life Threatening ◽  
Life Threatening Complication ◽  
Randomised Controlled

Cytokine storm is a life-threatening complication of Covid-19 infection. Excessive cytokines are the products of hyperactive immune inflammatory response mounted by the host against the virus. There is no agreed treatment for cytokine storm. Three therapeutic agents with proven immune-modulatory properties in regular use in a wide range of inflammatory disorders (high dose intravenous immunoglobulin, Rituximab and thalidomide) are proposed for the treatment of cytokine storm. Safety and efficacy of the proposed treatment should be assessed by randomised controlled clinical trials. The use of the proposed treatment is expected to reduce the mortality rate and alter the overall management of the pandemic.

Determining the safety and effectiveness of Tai Chi: A critical overview of 210 systematic reviews of controlled clinical trials

2021 ◽  
Author(s):  
Guo-Yan Yang ◽  
Jennifer Hunter ◽  
Fan-Long Bu ◽  
Wen-Li Hao ◽  
Han Zhang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Tai Chi ◽  
Controlled Clinical Trials ◽  
Language Bias ◽  
Important Benefit ◽  
Statistical Heterogeneity ◽  
Wide Range ◽  
Randomised Controlled ◽  
Meta Analyses

Abstract Background: This overview aims to critically appraise the best available systematic review (SR) evidence on the health effects of Tai Chi. Methods: Nine databases (English and Chinese languages) were searched for SRs of controlled clinical trials of Tai Chi interventions published between Jan-2010 and Dec-2020 in any language. Excluded were primary studies and meta-analyses that combined Tai Chi with other interventions. To minimise overlap, effect estimates were extracted from the most recent, comprehensive, highest quality SR for each population, condition, and outcome. SR quality was appraised using AMSTAR 2 and effect estimates with GRADE.Results: Of the 210 included SRs, 193 only included randomised controlled trials, one only included non-randomised studies of interventions, and 16 included both. The most common conditions were neurological (18.6%), falls/balance (14.7%), cardiovascular (14.7%), musculoskeletal (11.0%), cancer (7.1%) and diabetes mellitus (6.7%). Except for stroke, no evidence for disease prevention was found, instead proxy-outcomes/risks factors were evaluated. 114 effect estimates were extracted from 37 SRs (2 high quality, 6 moderate, 18 low, and 11 critically low), representing 59,306 adults. Compared to active and/or inactive controls, a clinically important benefit from Tai Chi was reported for 66 effect estimates; 53 reported an equivalent or marginal benefit, and 6 an equivalent risk of adverse events. Eight effect estimates (7.0%) were graded as high certainty evidence, 43 (37.7%) moderate, 36 (31.6%) low, and 27 (23.7%) very low. This was due to concerns with risk of bias in 92 (80.7%) effect estimates, imprecision in 43 (37.7%), inconsistency in 37 (32.5%) and publication bias in 3 (2.6%). SR quality was limited by the search strategies, language bias, inadequate consideration of clinical, methodological and statistical heterogeneity, poor reporting standards, and/or no registered protocol. Conclusions: The findings suggest Tai Chi has multisystem effects with physical, psychological, and quality of life benefits for a wide range of conditions, including individuals with multiple health problems. Clinically important benefits were most consistently reported for Parkinson’s disease, falls risk, knee osteoarthritis, low back pain, cardiovascular diseases including hypertension, and stroke. Notwithstanding, for most conditions, higher quality primary studies and SRs are required.

Sonothrombolysis in Patients With Acute Ischemic Stroke With Large Vessel Occlusion: An Individual Patient Data Meta-Analysis

Stroke ◽  
2021 ◽  
Author(s):  
Georgios Tsivgoulis ◽  
Aristeidis H. Katsanos ◽  
Jürgen Eggers ◽  
Vincent Larrue ◽  
Lars Thomassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Individual Patient Data ◽  
Intravenous Thrombolysis ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Controlled Clinical Trials ◽  
Vessel Occlusion ◽  
Safety And Efficacy ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

Background and Purpose: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials. Methods: We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time. Results: We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34]). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52]). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented. Conclusions: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.

scholarly journals Bevacizumab for pediatric radiation necrosis

2020 ◽  
Vol 7 (4) ◽  
pp. 409-414 ◽  
Author(s):  
Lorena V Baroni ◽  
Daniel Alderete ◽  
Palma Solano-Paez ◽  
Carlos Rugilo ◽  
Candela Freytes ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Radiation Necrosis ◽  
Treatment Options ◽  
Mass Effect ◽  
Pediatric Brain Tumors ◽  
Controlled Clinical Trials ◽  
Wide Range ◽  
Fluid Attenuated Inversion Recovery ◽  
Pediatric Brain

Abstract Background Radiation necrosis is a frequent complication occurring after the treatment of pediatric brain tumors; however, treatment options remain a challenge. Bevacizumab is an anti-VEGF monoclonal antibody that has been shown in small adult cohorts to confer a benefit, specifically a reduction in steroid usage, but its use in children has not been well described. Methods We describe our experience with bevacizumab use for symptomatic radiation necrosis at 5 institutions including patients treated after both initial irradiation and reirradiation. Results We identified 26 patients treated with bevacizumab for symptomatic radiation necrosis, with a wide range of underlying diagnoses. The average age at diagnosis of radiation necrosis was 10.7 years, with a median time between the last dose of radiation and the presentation of radiation necrosis of 3.8 months (range, 0.6-110 months). Overall, we observed that 13 of 26 patients (50%) had an objective clinical improvement, with only 1 patient suffering from significant hypertension. Radiological improvement, defined as reduced T2/fluid-attenuated inversion recovery signal and mass effect, was observed in 50% of patients; however, this did not completely overlap with clinical response. Both early and late radiation necrosis responded equally well to bevacizumab therapy. Overall, bevacizumab was very well tolerated, permitting a reduction of corticosteroid dose and/or duration in the majority of patients. Conclusions Bevacizumab appears to be effective and well-tolerated in children as treatment for symptomatic radiation necrosis and warrants more robust study in the context of controlled clinical trials.

Research in palliative care

2015 ◽  
Author(s):  
Stein Kaasa ◽  
Karen Forbes
Keyword(s):  
Palliative Care ◽  
Clinical Trials ◽  
Translational Research ◽  
Advanced Disease ◽  
Research Governance ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Wide Range

Research in palliative care is essential for maintaining standards and advancing knowledge and improving practice. It is challenging, sometimes daunting, often frustrating, but always exciting and rewarding when a study is successfully completed, whether the outcome is positive or negative. This chapter discusses a wide range of topics that will help those who are new to research to get started, to proceed and complete it, and contribute to improving outcomes for patients with advanced disease. Topics include, among others, collaborative and translational research, research governance, controlled clinical trials, evidence-based palliative care, and trial planning (including methodology, randomization, statistical considerations, protocol, access to patients, finance, administration, monitoring, and publication).

scholarly journals Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e039519 ◽  
Author(s):  
Fang Liu ◽  
Yuan Zhu ◽  
Jing Zhang ◽  
Yiming Li ◽  
Zhiyong Peng
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Study Protocol ◽  
Controlled Trial ◽  
Safety Data ◽  
High Dose ◽  
Advanced Malignancy ◽  
Health Crisis ◽  
Randomised Controlled ◽  
End Stage

IntroductionThe rapid worldwide spread of COVID-19 has caused a global health crisis. To date, symptomatic supportive care has been the most common treatment. It has been reported that the mechanism of COVID-19 is related to cytokine storms and subsequent immunogenic damage, especially damage to the endothelium and alveolar membrane. Vitamin C (VC), also known as L-ascorbic acid, has been shown to have antimicrobial and immunomodulatory properties. A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS). Therefore, we hypothesise that HIVC could be added to the treatment of ARDS and multiorgan dysfunction related to COVID-19.Methods and analysisThe investigators designed a multicentre prospective randomised placebo-controlled trial that is planned to recruit 308 adults diagnosed with COVID-19 and transferred into the intensive care unit. Participants will randomly receive HIVC diluted in sterile water or placebo for 7 days once enrolled. Patients with a history of VC allergy, end-stage pulmonary disease, advanced malignancy or glucose-6-phosphate dehydrogenase deficiency will be excluded. The primary outcome is ventilation-free days within 28 observational days. This is one of the first clinical trials applying HIVC to treat COVID-19, and it will provide credible efficacy and safety data. We predict that HIVC could suppress cytokine storms caused by COVID-19, help improve pulmonary function and reduce the risk of ARDS of COVID-19.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Zhongnan Hospital of Wuhan University (identifiers: Clinical Ethical Approval No. 2020001). Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.Trial registration numberNCT04264533.

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