Repurposing Ruxolitinib in Combating COVID-19: a mini review

2021 ◽  
Vol 02 ◽  
Author(s):  
Inshia Begum ◽  
Fathima Murthuza ◽  
Juwairiya Syed Iqbaluddin ◽  
Hafsah Fatima Arsal
Keyword(s):  
Clinical Trials ◽  
Severity Of Illness ◽  
Current Evidence ◽  
Public Healthcare ◽  
Inclusion Criteria ◽  
Research Papers ◽  
Exclusion Criteria ◽  
Mixed Treatment ◽  
Marked Selectivity ◽  
Insight Into

Background: The pandemic caused by Coronavirus Disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome-Related Coronavirus (SARS-CoV-2), is believed to be one of the greatest threats to global health in the 21st century. Recent collective evidence has warranted Ruxolitinib as a potential agent in recovery. Ruxolitinib is a potent and selective inhibitor of Jack kinase (JAK) 1 and 2 with modest to marked selectivity against tyrosine kinase two and JAK3. Objective: The review aims to outline the current evidence regarding the repurposed treatment for COVID- 19 and give insight into the clinical trials. There has been considerable interest in introducing existing therapeutic agents against COVID-19 to reduce the severity of illness and ease the burden on public healthcare systems. Method: A literature search was conducted using keywords like ‘Ruxolitinib trial’ and ‘COVID-19 Ruxolitinib’ on PubMed, Google Scholar, Science Direct, and Cochrane databases to select research papers and articles on the topic published from January to October 2020. Inclusion criteria were restricted to articles on Ruxolitinib and COVID. In contrast, the exclusion criteria stipulated that any study done on COVID-19 involving a mixed treatment regimen with Ruxolitinib and other drug/s or any studies not pertinent to the purpose of the study would be omitted. Conclusion: Based on the successful outcomes of various researches conducted and clinical trials performed, the use of Ruxolitinib has shown significant improvement and faster clinical recovery among COVID-19 patients of varying severity of infection, advanced age, and multiple comorbidities. This review provides an overview of various such studies with their promising outcomes.

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

Identification of the causes that influence recruitment in oncology clinical trials (OCT)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17562-e17562
Author(s):  
L. E. Fein ◽  
A. Romera ◽  
C. M. Micheri ◽  
M. I. Diaz ◽  
R. A. Sala
Keyword(s):  
Clinical Trials ◽  
Data Analysis ◽  
Informed Consent ◽  
Distant Metastases ◽  
Patient Recruitment ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Measurable Disease ◽  
Oncology Clinical Trials ◽  
Clinical Records

e17562 Background: Prediction of patient recruitment in OCT is one of the most important variables to guarantee timely closure of the trial. Earlier data analysis and conclusions define further research or discontinuation of the development of a given drug. Methods: Retrospective analysis of the recruitment and clinical records of all the patients of the COR that were contacted to participate in an OCT from 2006 to 2008 to identify the causes according to which patients did not participate. Results: Total of candidates 346, 175 women (50.6%). Average age 60 years (range 36 to 89). 42 patients (12%) rejected to participate in an OCT. 80 patients (23%) were screening failures (SF). 59 patients (17%) for not fulfilling an inclusion criteria (IC). Non appropriate stage or absence of measurable disease at screening (35%), abnormal labs (14%) and state of receptors or biomarkers (9%). Total of clinically unpredictable IC SF was 57.5%. 21 patients (6%) were SF due to an exclusion criteria (EC). Presence of distant metastases (12,5%), abnormal labs (2.5%) and abnormal EKG (2.5%). Total of clinically unpredictable EC SF was 19%. Conclusions: 35% of candidate patients did not participate. The most frequent cause was SF (23%). 76.5% of these SF were impossible to determine when informed consent was signed. 12% of patients rejected to participate for different reasons. Our results did not identify a predominant modifiable reason to improve recruitment. For future feasibility analyses our estimation of 35% dropout will be considered standard. [Table: see text] No significant financial relationships to disclose.

Effects of hesperidin consumption on cardiovascular risk biomarkers: a systematic review of animal studies and human randomized clinical trials

2019 ◽  
Vol 77 (12) ◽  
pp. 845-864 ◽  
Author(s):  
L Pla-Pagà ◽  
J Companys ◽  
L Calderón-Pérez ◽  
E Llauradó ◽  
R Solà ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cardiovascular Risk ◽  
Study Design ◽  
Animal Studies ◽  
Randomized Clinical Trials ◽  
Research Question ◽  
Current Evidence ◽  
Inclusion Criteria ◽  
Risk Biomarkers

Abstract Context The cardioprotective effects of the flavonoid hesperidin, which is present in citrus products, are controversial and unclear. This systematic review was conducted in accordance with the PRISMA 2015 guidelines. Objective To evaluate the current evidence from animal and human clinical studies and thus determine whether the consumption of hesperidin exerts beneficial effects on cardiovascular risk factors. Data sources PICOS (Population, Intervention, Comparison, Outcome, and Study Design) criteria defined the research question. Searches of the PubMed and Cochrane Plus databases were conducted and studies that met the inclusion criteria and were published in English in the last 15 years were included. Data extraction The first author, year of publication, study design, characteristics of animals and humans, intervention groups, dose of hesperidin, route of administration, duration of the intervention, cardiovascular risk biomarkers assessed, and results observed were extracted from the included articles. Results A total of 12 animal studies and 11 randomized clinical trials met the inclusion criteria. In the animal studies, the glucose, total and LDL cholesterol, and triglyceride levels decreased with chronic flavonoid consumption. In the human studies, endothelial function improved with flavonoid consumption, whereas no conclusive results were observed for the other biomarkers. Conclusions Animal studies have revealed that hesperidin and hesperetin consumption reduces glucose levels and various lipid profile parameters. However, a definitive conclusion cannot be drawn from the existing human clinical trials. Further research is needed to confirm whether the findings observed in animal models can also be observed in humans. Systematic Review Registration Prospero registration number CRD42018088942.

scholarly journals P126: Development of inclusion and exclusion criteria for ECPR in a regional hospital

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S101-S101
Author(s):  
D. Rollo ◽  
P. Atkinson ◽  
J. Fraser ◽  
J. Mekwan ◽  
J. P. French ◽  
...  
Keyword(s):  
Selection Criteria ◽  
Selection Process ◽  
Selection Criterion ◽  
Flow Time ◽  
Regional Hospital ◽  
Current Evidence ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Patient Selection Criterion ◽  
Selection Of

Introduction: Extracorporeal cardiopulmonary resuscitation (ECPR), a method of cardiopulmonary bypass, is increasingly being used to supplement traditional CPR to improve outcomes for cardiac arrest (CA). CA and particularly out of hospital CA (OHCA) have poor outcomes. Prior to development of a 3 phase ECPR program in a Canadian regional hospital, we wished to identify and optimize a practical selection process (inclusion and exclusion criteria) for patients who may benefit from ECPR. Methods: Using a locally modified Delphi technique, we followed a literature review to construct a proposed set of evidence based criteria with a questionnaire, where inclusion and exclusion criteria were scored by a selected group of 13 experts. Following 3 rounds, and additional review by an international expert in the field of ECPR, consensus was achieved for patient selection criterion. Results: First round responses achieved 87.5% agreement for selection of exclusion criteria. Inclusion criteria had agreement 62.5%. Responses to the second round for selection of inclusion criteria were unanimous at 100% with the exception of age parameters (<65 years vs. <70 years). The third and final set of criteria achieved 100% consensus though subsequent expert review refined a single exclusion criteria (asystole). Agreed inclusion criteria were: witnessed CA, age <70, refractory arrest, no flow time <10min, total downtime <60min, and a cardiac or select non-cardiac etiology (PE, drug OD, poisoning, hypothermia). Exclusion criteria were : unwitnessed arrest, asystole, certain etiologies (uncontrolled bleeding, irreversible brain damage, trauma), and comorbidities (severe disability limiting ADLs, standing DNR, palliation). Simplified criteria for EMS transport included witnessed OHCA, age, and no flow time. Conclusion: Selection criteria of candidates for ECPR are important components for any program. Expert consensus review of current evidence is an effective method for development of ECPR selection criteria.

scholarly journals Chloroquine, Hydroxychloroquine and Covid-19: a systematic review of literature

2020 ◽  
Vol 3 ◽  
pp. 1-10 ◽  
Author(s):  
Jose Paulo Guida
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Viral Load ◽  
Side Effects ◽  
Clinical Findings ◽  
Current Evidence ◽  
Review Of Literature ◽  
Inclusion Criteria ◽  
Methodological Issues

Objective: to assess effectiveness and safety of hydroxychloroquine and chloroquine on the treatment of COVID-19. Study desing: a systematic review of literature was performed in two databases; studies were included if they had as intervention use of chloroquine or hydroxychloroquine and reported outcomes on laboratorial or clinical findings or description of side effects. Results: 38 studies were included; of those, only one fulfilled inclusion criteria and were included in this review. This study has important methodological issues and only reported viral load, but any clinical outcomes. Conclusions: Many ongoing clinical trials will provide new evidences about the use of hydroxychloroquine and chloroquine to the treatment of COVID-19. Current evidence do not support its use on clinical practice.

Representativeness of the patients admitted to psychiatric inpatient units for hypothetical participation in practical clinical trial CATIE

2011 ◽  
Vol 26 (S2) ◽  
pp. 1369-1369
Author(s):  
M.C. Díaz ◽  
N. Morales ◽  
K. Nieto ◽  
E. Iniesta ◽  
M.A. Martin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
External Validity ◽  
Psychiatric Inpatient ◽  
Internal Validity ◽  
Clinical Population ◽  
Psychiatric Ward ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Psychiatric Inpatient Unit ◽  
Inpatient Units

IntroductionPharmacological treatment of patients with schizophrenia and other psychoses get scientific backing of its main clinical trials. Methodological guarantees these test tend to strengthen the internal validity of the results at the expense of external validity and the ability to generalize the results to the clinical population. For this reason, and to minimize the shortcomings of external validity while maintaining internal validity, has been promoted in recent years to carry out large clinical trials based on clinical practice. This type of test expands the criteria for inclusion, limiting the exclusion criteria to incorporate as many patients as possible. The first and most significant of these trials was the CATIE trial (Lieberman et al, 2005).ObjectivesDiscuss eligibility patients admitted during the year 2009 in a psychiatric inpatient unit with a diagnosis of schizophrenia for participation in CATIE.MethodsA total of 145 patients (27.6% females, mean age 39.6+/−12.8 years), consecutively admitted to an inpatient psychiatric ward with a clinical diagnosis of schizophrenia or other psychoses were assessed to test if they would fulfill criteria for participation in CATIE.Results60 (41.4%) patients did not fulfill CATIE inclusion criteria. Mental retardation (n = 22, p < 0.001), absence of consent (n = 15, p < 0.001) and refusal to take oral medication (n = 12, p < 0.001) were the main factors responsible for not meeting criteria. Meeting the criteria was not significantly related to gender or specific diagnosis.ConclusionsThe 41.38% of patients did not meet criteria for participation in the CATIE study.

Adverse Effects of Natural Products: A Brief Pre-Systematic Review

2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Natural Products ◽  
Adverse Events ◽  
In Vitro Study ◽  
Google Scholar ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

scholarly journals On the design of early-phase Alzheimer’s disease clinical trials with cerebrospinal fluid tau outcomes

2021 ◽  
pp. 174077452110344
Author(s):  
Michelle M Nuño ◽  
Joshua D Grill ◽  
Daniel L Gillen ◽  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cerebrospinal Fluid ◽  
Phosphorylated Tau ◽  
Inclusion Criteria ◽  
Eligibility Criteria ◽  
Total Tau ◽  
Prodromal Alzheimer’S Disease ◽  
Study Power

Background/Aims: The focus of Alzheimer’s disease studies has shifted to earlier disease stages, including mild cognitive impairment. Biomarker inclusion criteria are often incorporated into mild cognitive impairment clinical trials to identify individuals with “prodromal Alzheimer’s disease” to ensure appropriate drug targets and enrich for participants likely to develop Alzheimer’s disease dementia. The use of these eligibility criteria may affect study power. Methods: We investigated outcome variability and study power in the setting of proof-of-concept prodromal Alzheimer’s disease trials that incorporate cerebrospinal fluid levels of total tau (t-tau) and phosphorylated (p-tau) as primary outcomes and how differing biomarker inclusion criteria affect power. We used data from the Alzheimer’s Disease Neuroimaging Initiative to model trial scenarios and to estimate the variance and within-subject correlation of total and phosphorylated tau. These estimates were then used to investigate the differences in study power for trials considering these two surrogate outcomes. Results: Patient characteristics were similar for all eligibility criteria. The lowest outcome variance and highest within-subject correlation were obtained when phosphorylated tau was used as an eligibility criterion, compared to amyloid beta or total tau, regardless of whether total tau or phosphorylated tau were used as primary outcomes. Power increased when eligibility criteria were broadened to allow for enrollment of subjects with either low amyloid beta or high phosphorylated tau. Conclusion: Specific biomarker inclusion criteria may impact statistical power in trials using total tau or phosphorylated tau as the primary outcome. In concert with other important considerations such as treatment target and population of clinical interest, these results may have implications to the integrity and efficiency of prodromal Alzheimer’s disease trial designs.

scholarly journals Functional Food—Consumer Motivations and Expectations

2021 ◽  
Vol 18 (10) ◽  
pp. 5327
Author(s):  
Kinga Topolska ◽  
Adam Florkiewicz ◽  
Agnieszka Filipiak-Florkiewicz
Keyword(s):  
Functional Food ◽  
Consumer Attitudes ◽  
Evidence Based ◽  
Nutritional Knowledge ◽  
Future Perspectives ◽  
Research Papers ◽  
Adequate Knowledge ◽  
Food Market ◽  
And Behavior ◽  
Insight Into

This review provides insight into consumer attitudes toward functional food (FF), with the purpose of better understanding the needs and behavior regarding this kind of product. A total of 47 articles were selected for this paper. The available studies from last 20 years differ according to the focus (awareness, attitudes, motivations, willingness, acceptance by consumers) and methodologies used. Several factors, including socio-demographic, cognitive and attitudinal ones, seem to be serve as the basis for the acceptance of functional products. The research papers showed that nutritional knowledge is the most important of these. Older people are more interested in functional products than younger consumers, because of their stronger belief in the health benefits of FF. Moreover, women are more open to compromise between taste and health properties. Claims concerning the disease preventative properties of FF are the most attractive for consumers. This review focuses also on future perspectives for the functional food market. Adequate knowledge and evidence-based communication seem to be the most promising ways to increase consumers’ interest in these kinds of products.

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