scholarly journals Why did the “ESSENSE Project Multicenter Prospective Clinical Trials” fail to produce positive results?

2021 ◽  
Vol 55 (6) ◽  
pp. 221-227
Author(s):  
Masaki Kaibori ◽  
Go Miyata ◽  
Hideki Taniguchi ◽  
Yoshihiro Nabeya ◽  
Kazuhiko Fukatsu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Positive Results

The impact of Vaccination worldwide on SARS-CoV-2 infection: A Review on Vaccine Mechanisms, Results of Clinical Trials, Vaccinal Coverage and Interactions with Novel Variants

2021 ◽  
Vol 28 ◽  
Author(s):  
Douglas Henrique Pereira Damasceno ◽  
Arthur Aguiar Amaral ◽  
Cecília Andrade Silva ◽  
Ana Cristina Simões e Silva
Keyword(s):  
Immune Response ◽  
Clinical Trials ◽  
Placebo Group ◽  
Mechanisms Of Action ◽  
Novel Variants ◽  
The Impact ◽  
Positive Results ◽  
Epidemiological Information ◽  
Long Term Studies

Background: The COVID-19 pandemic demanded a global effort towards quickly developing safe and effective vaccines against SARS-CoV-2. Objective: This review aimed to discuss the main vaccines available, their mechanisms of action, results of clinical trials and epidemiological behavior. The implications of viral variants were also debated. Methods: A non-systematic literature review was performed between February and March 2021 by searching the Pubmed, Scopus, and SciELO databases, using different combinations of the following terms: "vaccines", "clinical trials" , "SARS-CoV-2", "Coronavirus", "COVID-19", "mechanisms of action". Data regarding clinical trials of SARS-CoV-2 vaccines and epidemiological information were also searched. Results: The mechanisms of action included vector-virus, mRNA and inactivated virus vaccines. The vaccines showed positive results in phases 2/3 clinical trials. The efficacy of the mRNA 1273 and of mRNA BNT 162b2 vaccines were 94.1% and 95%, respectively. The effectiveness of the ChAdOx1 nCoV-19 vaccine varied according to the scheme, with an overall value of 70.4%. The Gam-COVID-Vac vaccine had an efficacy of 91.6%. Regarding the Ad26.COV2.S vaccine, 99% or more of seroconversion was observed in all subgroups 29 days after vaccination. The CoronaVac vaccine induced an immune response in 92% of the volunteers receiving 3ug and in 98% with 6ug, in comparison to 3% in the placebo group. Conclusion: Global efforts have resulted in vaccines available in record time, with good safety and immunogenicity profile. However, only long-term studies can provide more information on duration of immunity and the need for additional doses.

scholarly journals Intestinal Microbiota and Allergy. Probiotics and Prebiotics in Prevention and Treatment of Allergic Diseases

2019 ◽  
Vol 16 (1) ◽  
pp. 7-18 ◽  
Author(s):  
Svetlana G. Makarova ◽  
Leyla S. Namazova-Baranova ◽  
Oksana A. Ereshko ◽  
Dmitry S. Yasakov ◽  
Pavel E. Sadchikov
Keyword(s):  
Immune Response ◽  
Clinical Trials ◽  
Intestinal Microbiota ◽  
Practical Interest ◽  
Allergic Diseases ◽  
Evidence Based ◽  
Prevention And Treatment ◽  
The Impact ◽  
Positive Results ◽  
Intestinal Microbiocenosis

Intestinal microbiota is the factor that identifies considerably the human health. The impact of the microbial factor on a child begins long before his birth. Children have certain features in forming of immune response and intestinal microbiocenosis even before birth. Decline in diversity of intestinal microbiota is common in children with allergic disease even during first months of life, before allergic pathology development. Capabilities for microbiota development adjustment are sufficiently restricted. However it is clinically proven that early (within the first hours of life) breastfeeding attachment, breastfeeding itself within at least first 6 months of life, the use of prebiotics in milk formulas as well as the use of probiotics can give positive results on allergy management. In this review we present results of recent metaanalyses and consensus papers of international medical communities about use of probiotics and prebiotics in prevention and treatment of allergic diseases. Despite great scientific and practical interest to this topic, authors of metaanalyses bring our attention to the lack of evidence-based clinical trials.

Positive Results Bias and Impact Factor in Retina Clinical Trials 2016-2019

Retina ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Ankur Parikh ◽  
Jonathan Markle ◽  
Michael Venincasa ◽  
Ajay E. Kuriyan ◽  
Mrinali Gupta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Impact Factor ◽  
Positive Results

Large-scale randomized evidence: Trials and meta-analyses of trials

2020 ◽  
pp. 51-66
Author(s):  
Colin Baigent ◽  
Richard Peto ◽  
Richard Gray ◽  
Natalie Staplin ◽  
Sarah Parish ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Meta Analysis ◽  
False Negative ◽  
Premature Deaths ◽  
Common Causes ◽  
The Common ◽  
Meta Analyses ◽  
Positive Results

Clinical trials generally need to be able to detect or to refute realistically moderate (but still worthwhile) differences between treatments in long-term disease outcome. Large-scale randomized evidence should be able to detect such effects, but medium-sized trials or medium-sized meta-analyses can, and often do, yield false-negative or exaggeratedly positive results. Hundreds of thousands of premature deaths each year could be avoided by seeking appropriately large-scale randomized evidence about various widely practicable treatments for the common causes of death, and by disseminating this evidence appropriately. This chapter takes a look at the use of large-scale randomized evidence—produced from trials and meta-analysis of trials—and how this data should be handled in order to produce accurate result.

Learning from the Past: A Review of Clinical Trials Targeting Amyloid, Tau and Neuroinflammation in Alzheimer’s Disease

2020 ◽  
Vol 17 (2) ◽  
pp. 112-125 ◽  
Author(s):  
Kelly Ceyzériat ◽  
Thomas Zilli ◽  
Philippe Millet ◽  
Giovanni B. Frisoni ◽  
Valentina Garibotto ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Animal Models ◽  
Phase Iii ◽  
Current Status ◽  
Central Feature ◽  
Phase Iii Trial ◽  
The Past ◽  
Positive Results

Alzheimer’s Disease (AD) is the most common neurodegenerative disease and cause of dementia. Characterized by amyloid plaques and neurofibrillary tangles of hyperphosphorylated Tau, AD pathology has been intensively studied during the last century. After a long series of failed trials of drugs targeting amyloid or Tau deposits, currently, hope lies in the positive results of one Phase III trial, highly debated, and on other ongoing trials. In parallel, some approaches target neuroinflammation, another central feature of AD. Therapeutic strategies are initially evaluated on animal models, in which the various drugs have shown effects on the target (decreasing amyloid, Tau and neuroinflammation) and sometimes on cognitive impairment. However, it is important to keep in mind that rodent models have a less complex brain than humans and that the pathology is generally not fully represented. Although they are indispensable tools in the drug discovery process, results obtained from animal models must be viewed with caution. In this review, we focus on the current status of disease-modifying therapies targeting amyloid, Tau and neuroinflammation with particular attention on the discrepancy between positive preclinical results on animal models and failures in clinical trials.

scholarly journals Clinical Trials with Herbal Products for the Prevention of Dental Caries and Their Quality: A Scoping Study

2019 ◽  
Author(s):  
Robert Ancuceanu ◽  
Adriana Iuliana Anghel ◽  
Camelia Ionescu ◽  
Marilena Viorica Hovaneț ◽  
Maria Cojocaru-Toma ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Preliminary Evidence ◽  
Caries Prevention ◽  
Public Health Issue ◽  
Quality Of Reporting ◽  
Design Quality ◽  
Herbal Products ◽  
Study Designs ◽  
Positive Results

It is currently recognized that an injudicious strategy in the last decades has been not only focusing of research typically on caries in children, but also the narrow focusing on fluoride, because despite sufficient availability of fluoride in water and oral healthcare products, caries levels escalate steadily as people get older and caries remain a main public health issue to be settled. In the last two decades the scientific community intensified efforts of exploring other products for caries prevention, herbal products being one of these approaches. Because preliminary evidence indicated that clinical trials for caries prevention with herbal products are heterogeneous in design, quality and products evaluated, we performed a scoping review intended to explore the main characteristics of such clinical trials. From an initial collection of 1986 unique papers from different literature databases, 56 articles satisfied the inclusion and exclusion criteria. The species investigated, dosage forms, study designs, duration of intervention, controls, endpoints, quality of reporting and risk of bias are discussed. 85.71% of the trials reviewed here reported positive results but given the methodological flaws and biases affecting them, it is difficult to conclude on the efficacy of those products based on the studies published thus far.

scholarly journals Thinking Outside the Ischemia Box: Advancements in the Use of Multiple Sclerosis Drugs in Ischemic Stroke

2021 ◽  
Vol 10 (4) ◽  
pp. 630
Author(s):  
Athina-Maria Aloizou ◽  
Vasileios Siokas ◽  
Georgia Pateraki ◽  
Ioannis Liampas ◽  
Christos Bakirtzis ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Ischemic Stroke ◽  
Early Intervention ◽  
Cause Of Death ◽  
Nervous Tissue ◽  
Inflammatory Process ◽  
Disease Modifying Drugs ◽  
Disease Modifying ◽  
Positive Results

Ischemic stroke (IS) is a major cause of death and disability, despite early intervention. Thrombo-inflammation, the inflammatory process triggered by ischemia, is a concept that ties IS with multiple sclerosis (MS), under the wider ‘umbrella’ of neuroinflammation, i.e., the inflammation of the nervous tissue. Drawing from this, numerous studies have explored the potential of MS disease-modifying drugs in the setting of IS. In this review, we present the available studies and discuss their potential in ameliorating IS outcomes. Based on our search, the vast majority of the studies have been conducted on animals, yielding mostly positive results. Two clinical trials involving natalizumab showed that it does not confer any benefits, but four human studies regarding fingolimod have showcased its potential in improving recovery prospects. However, concerns on safety and other issues are raised, and basic questions still need to be answered.

scholarly journals Clinical Trials with Herbal Products for the Prevention of Dental Caries and Their Quality: A Scoping Study

Biomolecules ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. 884 ◽  
Author(s):  
Robert Ancuceanu ◽  
Adriana Iuliana Anghel ◽  
Camelia Ionescu ◽  
Marilena Viorica Hovaneț ◽  
Maria Cojocaru-Toma ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Preliminary Evidence ◽  
Caries Prevention ◽  
Public Health Issue ◽  
Quality Of Reporting ◽  
Design Quality ◽  
Herbal Products ◽  
Study Designs ◽  
Positive Results

It is currently recognized that an injudicious strategy about caries in the last decades has been not only focusing of research mostly in children, but also the narrow focusing on fluoride, because despite sufficient availability of fluoride in water and oral healthcare products, caries levels escalate steadily as people get older and caries remain a main public health issue to be settled. In the last two decades the scientific community intensified efforts of exploring other products for caries prevention, herbal products being one of these approaches. Preliminary evidence indicated that clinical trials for caries prevention with herbal products are heterogeneous in design, quality and products evaluated, we therefore performed a scoping review intended to explore the main characteristics of such clinical trials. From an initial collection of 1986 unique papers from different literature databases, 56 articles satisfied the inclusion and exclusion criteria. The species investigated, dosage forms, study designs, duration of intervention, controls, endpoints, quality of reporting, and risk of bias are discussed. Of the trials reviewed here, 85.71% reported positive results but given the methodological flaws and biases affecting them, it is difficult to conclude on the efficacy of those products based on the studies published thus far.

scholarly journals An analysis of clinical trials registered with CTRI in India from 2007 to 2015

2016 ◽  
Vol 3 (3) ◽  
pp. 155
Author(s):  
Vihang S. Chawan ◽  
Sagar V. Badwane ◽  
Kalpesh V. Gawand ◽  
Maheshi U. Chhaya
Keyword(s):  
Clinical Trials ◽  
Gold Standard ◽  
Evidence Based ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Negative Results ◽  
Potential Risks ◽  
Wide Gap ◽  
Based Medicine ◽  
Positive Results

<p class="abstract"><strong>Background:</strong> Clinical trials are gold standard in the field of evidence based medicine. Registration of clinical trials facilitates the dissemination of information among clinicians, researchers and patients. Earlier, researchers were interested only in publishing positive results of their study. The negative results were never published resulting in bias in reporting the results of such clinical trials. It is now mandatory to register all clinical trials done in India at National Institute of Medical Statistics (NIMS) hosted at Clinical Trial Registry - India (CTRI) website to ensure transparency, accountability and accessibility of clinical trials. This study was planned to analyze the number of clinical trials registered under CTRI from 2007 to 2015. The information regarding the registration of clinical trials was accessed from the website www.ctri.nic.in.</p><p class="abstract"><strong>Methods:</strong> The information on registered clinical trials was obtained from the website www.ctri.nic.in. The clinical trials registered with CTRI from 2007 to 2015 were noted for analysis.</p><p class="abstract"><strong>Results:</strong> Maximum number of clinical trials registered in the year 2015 (1113), followed by year 2014 (1089), 2013 (990), 2012 (959) and 2011 (748) while least number of clinical trials registered in the year 2007 (32). Results revealed that there is wide gap the number of clinical trials registered in between year 2007 to 2015 and also revealed that number of clinical trials registered are increasing in order from year 2007 to year 2015.  </p><strong>Conclusions:</strong> The registrations of clinical trials improve the reliability of data generated, assist clinicians to interpret research, minimizes duplication of trials and prevents exposure of volunteers to potential risks.

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