scholarly journals Outcome assessment in axial spondyloarthritis-imaging techniques, their relation to outcomes and their use in clinical trials

2013 ◽  
Vol 8 ◽  
pp. S38-S43 ◽  
Author(s):  
Xenofon Baraliakos ◽  
Juergen Braun
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment ◽  
Axial Spondyloarthritis ◽  
Imaging Techniques

Abstract P391: Marine N-3 Fatty Acids Reduce Atherosclerosis Cardiovascular Disease: A Systemic Review and Meta-analysis of Clinical Trials

Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Akira Sekikawa ◽  
Nobutake Hirooka ◽  
Abhishek Vishnu ◽  
Vashudha Ahuja ◽  
Emmanuel Sampene ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Fatty Acids ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Imaging Techniques ◽  
Meta Analysis ◽  
Quantitative Information ◽  
Systemic Review ◽  
Cochrane Library ◽  
Cardiac Imaging Techniques

Introduction: Although marine n-3 fatty acids are believed to be cardioprotective through their anti-arrhythmic, anti-thrombotic, anti-atherogenic and other effects, results from recent meta-analyses of marine n-3 fatty acids on cardiovascular disease (CVD) are controversial. We performed a meta-analysis of marine n-3 fatty acids on CVD outcomes in randomized clinical trials (RCTs) to test the hypothesis that marine n-3 fatty acids are anti-atherogenic. We also tested the hypothesis that such benefit is dose-dependent. Methods: A systematic review of English language articles using PubMed, EMBASE and Cochrane Library through Aug 2012 was performed selecting RCTs evaluating the effect of marine n-3 fatty acids intake for 2 years or more on cardiovascular diseases, coronary disease, arteriosclerosis, cardiac imaging techniques, and carotid artery ultrasound. Descriptive and quantitative information was extracted. Odds ratios were calculated for cardiac event outcome. Correlation coefficients were obtained from studies of which outcome is intima-media thickness (IMT) and coronary lumen diameter (CD). We converted the estimates into a single effect size; the log odds ratio and its corresponding standard error. Results: Of 14,236 citations retrieved, 13 studies were selected, including studies reporting IMT (n=3) and CD (n=2) and major CVD events (n=8). Overall, marine n-3 fatty acids significantly reduced atherosclerotic CVD (RR 0.94: 95%CI 0.90 to 0.99, p<0.05). There was no evidence of heterogeneity (p=0.65) or publication bias (p=0.37, Begg’s test). A sub-analysis among 8 studies of major CVD events showed the similar results (RR 0.94: 95% CI 0.89 to 0.99, p<0.05). Another sub-analysis among 4 studies excluding sudden cardiac death as an outcome showed RR of 0.91 (95% CI 0.82 to 1.02, p=0.097). A meta-regression analysis shows that dose of marine n-3 fatty acids was inversely associated with CVD outcome, although the association was not statistically significant (p=0.06). Conclusions: The result of our meta-analysis supports a modest anti-atherogenic effect of marine n-3 fatty acids. This benefit may be proportional to the amount of marine n-3 fatty acids consumed.

Twenty years of clinical trials in axial spondyloarthritis

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Joachim Sieper ◽  
Denis Poddubnyy
Keyword(s):  
Clinical Trials ◽  
Axial Spondyloarthritis

scholarly journals Organoids: life in three dimensions- a review

2019 ◽  
Vol 7 (1) ◽  
pp. 5
Author(s):  
Akhila CNV ◽  
Ravi Prakash A ◽  
Rajini Kanth M ◽  
Sreenath G ◽  
Sowmya K ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Testing ◽  
Molecular Level ◽  
Imaging Techniques ◽  
Three Dimensions ◽  
Vaccine Production ◽  
Research Fields ◽  
Complex Interactions ◽  
Open The Doors ◽  
Dimensional Cell

Most of the diseases in humans are as a result of complex interactions occurring at cellular and molecular level. Research today has been focused in an attempt to reveal precisely the cellular evolution into pathogenesis. There are vast array of research fields, which include molecular biology, imaging techniques, etc. One of such field recently advancing worldwide is “Organotyping”. It is the successor of two dimensional cell cultures. Miniature organs and disease models can be produced from cells having the ability to proliferate and differentiate, by adopting definite protocols. Organoids are the potential tools to probe human biology and diseases; thereby they may change the approach to study diseases and provide treatment, in a more beneficiary way to the patient. Also organoids are used in vaccine production, cancer research, microbiology, tissue regeneration, drug testing, etc. Clinical trials are more devastating and may cost life of patients included in study. As such, organoids can be included in the protocols of clinical trials, through which the outcome of the study can be estimated. They open the doors for newer research methods and innovations, which are in peak requirement of present day scenario where new diseases are emerging and the diseases already existing are not yet cured.   

scholarly journals Real-world evidence of TNF inhibition in axial spondyloarthritis: can we generalise the results from clinical trials?

2020 ◽  
Vol 79 (7) ◽  
pp. 914-919 ◽  
Author(s):  
Gareth T Jones ◽  
Linda E Dean ◽  
Ejaz Pathan ◽  
Rosemary J Hollick ◽  
Gary J Macfarlane
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Response ◽  
Real World ◽  
Axial Spondyloarthritis ◽  
British Society ◽  
Symptom Duration ◽  
Clinical Records ◽  
Trial Participants

Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.

Imaging Criteria in Neuro-oncology

2018 ◽  
Vol 38 (01) ◽  
pp. 024-031 ◽  
Author(s):  
Martha Nowosielski ◽  
Patrick Wen
Keyword(s):  
Clinical Trials ◽  
Brain Tumors ◽  
Imaging Techniques ◽  
Response Assessment ◽  
Pediatric Brain Tumors ◽  
Macdonald Criteria ◽  
Collective Work ◽  
Positron Emission ◽  
Oncology Clinical Trials ◽  
Group A

The identification of more effective therapies for brain tumors has been limited in part by the lack of reliable criteria for determining response and progression. Since its introduction in 1990, the MacDonald criteria have been used in neuro-oncology clinical trials to determine response, but they fail to address issues such as pseudoprogression, pseudoresponse, and nonenhancing tumor progression that have arisen with more recent therapies. The Response Assessment in Neuro-Oncology (RANO) working group, a multidisciplinary international group consisting of neuro-oncologists, medical oncologists, neuroradiologists, neurosurgeons, radiation oncologists, and neuropsychologists, was formed to improve response assessment and clinical trial endpoints in neuro-oncology. Although it was initially focused on response assessment for gliomas, the scope of the RANO group has been broadened to include brain metastases, leptomeningeal metastases, spine tumors, pediatric brain tumors, and meningiomas. In addition, subgroups have focused on response assessment during immunotherapy and use of positron emission tomography, as well as determination of neurologic function, clinical outcomes assessment, and seizures. The RANO criteria are currently a collective work in progress, and refinements will be needed in the future based on data from clinical trials and improved imaging techniques.

The Chymopapain Clinical Trials

Neurosurgery ◽  
1985 ◽  
Vol 17 (1) ◽  
pp. 107-110 ◽  
Author(s):  
Stephen J. Haines
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment ◽  
Therapeutic Efficacy ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Successful Outcome ◽  
Relative Efficacy ◽  
Number Of Patients ◽  
Current Controversy ◽  
Probability Of Success

Abstract The three published randomized clinical trials of chymopapain injection vs. placebo injection for the treatment of herniated lumbar discs are reviewed. Despite some differences, the similarities in selection criteria, technique, and outcome assessment are great enough to justify pooling the results to obtain an overall assessment of chymopapain efficacy. These pooled results suggest that the odds of successful outcome (at least some improvement in symptoms after injection) are 2.6 times as great with chymopapain injection as those after placebo injection. This corresponds to a 50% greater probability of success with chymopapain than with placebo or a 23% increase in the number of patients successfully treated with chemonucleolysis over those successfully treated with placebo. The fact that data from 234 patients evaluated in randomized clinical trials could resolve a controversy over therapeutic efficacy that the uncontrolled evaluation of over 20,000 patients could not answer suggests that the current controversy over the relative efficacy of chymopapain and discectomy should be studied in the same way. The difficulties of such a study are discussed. (Neurosurgery 17:107-110, 1985)

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