scholarly journals Remdesivir: Critical Clinical Appraisal for COVID 19 Treatment

Drug Research ◽  
2020 ◽  
Author(s):  
Saptarshi Chatterjee
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Promising Result ◽  
Drug Repurposing ◽  
In Vitro Studies ◽  
Therapeutic Molecules ◽  
Regulatory Aspect ◽  
Plausible Mechanism

AbstractRemdesivir is presently been considered as ‘molecule of hope’ to curb the menace of COVID19. Non-availability of any USFDA approved drug has led to several attempt of drug-repurposing and development of new therapeutic molecules. However, Remdesivir has been found to be effective against a broad range of virus including SARS, MERS and COVID 19 through in-vitro studies. Several clinical research attempt are presently being conducted showing promising result yet not conclusive. This review summarized all such clinical trials to critically appraise the usage of Remdesivir against COVID 19 along with the publications related to the results of the clinical studies. The present regulatory aspect i. e. Emergency Use Authorization (EYA) and information of molecule and plausible mechanism is also dealt.

scholarly journals Pharmacological effects of saffron and its constituents in ocular disorders from in vitro studies to clinical trials; a systematic review

2020 ◽  
Vol 18 ◽  
Author(s):  
Samaneh Sepahi ◽  
Adel Ghorani-Azam ◽  
Seyedeh Maryam Hossieni ◽  
Seyed Ahmad Mohajeri ◽  
Elham Khodavrdi
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Therapeutic Potential ◽  
In Vitro Studies ◽  
Therapeutic Effects ◽  
Potential Candidate ◽  
Retinal Cells ◽  
Age Related ◽  
Eye Disorders

Introduction: Some medicinal plants have shown promising therapeutic potential for management of the diseases. We aimed to systematically review the literature wherein the therapeutic effects of saffron have been studied on eye disorders. Methods: A systematic literature search was performed in PubMed, Scopus, Web of Science, Google scholar and other databases using eye disorders, and saffron as key terms. No strict inclusion criteria were defined, and almost all clinical studies, as well as in vivo and in vitro studies were included. The reported data in each study were extracted and then qualitatively described. Results: Finally, 78 articles were found but only 29 relevant articles were included. Nine articles are clinical trials and 20 articles were done on cellular and molecular aspects of saffron on eye disorders. According to the included studies, crocin prevented the pro-inflammatory response in retinal cells and decreased glucose level in diabetic mice. Also, crocetin prevented retinal degeneration and saffron protected photoreceptors from light-induced damage in retinal cells. Saffron also improved visual function in age-related macular edema and decreased intraocular pressure in patients with glaucoma. In addition, it was shown that crocin can improve best corrected visual acuity and decreased central macular thickness in patients with diabetic maculopathy. Conclusion: The results of this review indicated that saffron and its main ingredients such as crocin could be a potential candidate for the treatment of ocular disease especially eye inflammation; however, further clinical studies are needed to confirm such efficiency.

scholarly journals Stem Cells as a Model of Study of SARS-CoV-2 and COVID-19: A Systematic Review of the Literature

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
María Verónica Cuevas-Gonzalez ◽  
Álvaro Garcia-Perez ◽  
Álvaro Edgar Gonzalez-Aragon Pineda ◽  
León Francisco Espinosa-Cristobal ◽  
Alejandro Donohue-Cornejo ◽  
...  
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Stem Cell ◽  
Clinical Studies ◽  
Case Series ◽  
In Vitro Studies ◽  
In Vivo Studies

Background. The SARS-CoV-2 virus is the cause of the latest pandemic of the 21st century; it is responsible for the development of COVID-19. Within the multiple study models for both the biology and the treatment of SARS-CoV-2, the use of stem cells has been proposed because of their ability to increase the immune response and to repair tissue. Therefore, the objective of this review is to evaluate the role of stem cells against SARS-CoV-2 and COVID-19 in order to identify their potential as a study model and as a possible therapeutic source against tissue damage caused by this virus. Therefore, the following research question was established: What is the role of stem cells in the study of SARS-CoV-2 and the treatment of COVID-19? Materials and Methods. A search was carried out in the electronic databases of PUBMED, Scopus, and ScienceDirect. The following keywords were used: “SARS-CoV-2,” “COVID-19,” and “STEM CELL,” plus independent search strategies with the Boolean operators “OR” and “AND.” The identified reports were those whose main objective was the study of stem cells in relation to SARS-CoV-2 or COVID-19. For the development of this study, the following inclusion criteria were taken into account: studies whose main objective was the study of stem cells in relation to SARS-CoV-2 or COVID-19 and clinical case studies, case reports, clinical trials, pilot studies, in vitro, or in vivo studies. For assessment of the risk of bias for in vitro studies, the SciRAP tool was used. The data collected for each type of study, clinical or in vitro, were analyzed with descriptive statistics using the SPSS V.22 program. Results. Of the total of studies included ( n = 39 ), 22 corresponded to in vitro investigations and 17 to human studies (clinical cases ( n = 9 ), case series ( n = 2 ), pilot clinical trials ( n = 5 ), clinical trials ( n = 1 )). In vitro studies that induced pluripotent stem cells were the most used ( n = 12 ), and in clinical studies, the umbilical stem cells derived were the most reported ( n = 11 ). The mean age of the study subjects was 58.3 years. After the application of stem cell therapy, the follow-up period was 8 days minimum and 90 days maximum. Discussion. The mechanism by which the virus enters the cell is through protein “S,” located on the surface of the membrane, by recognizing the ACE2 receptor located on the target cell. The evidence that the expression of ACE2 and TMPRSS2 in stem cells indicates that stem cells from bone marrow and amniotic fluid have very little expression. This shows that stem cell has a low risk of infection with SARS-CoV-2. Conclusion. The use of stem cells is a highly relevant therapeutic option. It has been shown in both in vitro studies and clinical trials that it counteracts the excessive secretion of cytokines. There are even more studies that focus on long-term follow-up; thus, the potential for major side effects can be analyzed more clearly. Finally, the ethical use of stem cells from fetal or infant origin needs to be regulated. The study was registered in PROSPERO (no. CRD42021229038). The limitations of the study were because of the methodology employed, the sample was not very large, and the follow-up period of the clinical studies was relatively short.

scholarly journals In Vitro,In Vivo, and Clinical Studies of Tedizolid To Assess the Potential for Peripheral or Central Monoamine Oxidase Interactions

2013 ◽  
Vol 57 (7) ◽  
pp. 3060-3066 ◽  
Author(s):  
S. Flanagan ◽  
K. Bartizal ◽  
S. L. Minassian ◽  
E. Fang ◽  
P. Prokocimer
Keyword(s):  
Blood Pressure ◽  
Monoamine Oxidase ◽  
Clinical Research ◽  
Systolic Blood Pressure ◽  
Clinical Studies ◽  
Geometric Mean ◽  
Interaction Study ◽  
Mao B ◽  
Mao A

ABSTRACTTedizolid phosphate is a novel oxazolidinone prodrug whose active moiety, tedizolid, has improved potency against Gram-positive pathogens and pharmacokinetics, allowing once-daily administration. Given linezolid warnings for drug-drug and drug-food interactions mediated by monoamine oxidase (MAO) inhibition, including sporadic serotonergic toxicity, these studies evaluated tedizolid for potential MAO interactions.In vitro, tedizolid and linezolid were reversible inhibitors of human MAO-A and MAO-B; the 50% inhibitory concentration (IC50) for tedizolid was 8.7 μM for MAO-A and 5.7 μM for MAO-B and 46.0 and 2.1 μM, respectively, with linezolid. Tedizolid phosphate was negative in the mouse head twitch model of serotonergic activity. Two randomized placebo-controlled crossover clinical studies assessed the potential of 200 mg/day tedizolid phosphate (at steady state) to enhance pressor responses to coadministered oral tyramine or pseudoephedrine. Sensitivity to tyramine was determined by comparing the concentration of tyramine required to elicit a ≥30-mmHg increase in systolic blood pressure (TYR30) when administered with placebo versus tedizolid phosphate. The geometric mean tyramine sensitivity ratio (placebo TYR30/tedizolid phosphate TYR30) was 1.33; a ratio of ≥2 is considered clinically relevant. In the pseudoephedrine study, mean maximum systolic blood pressure was not significantly different when pseudoephedrine was coadministered with tedizolid phosphate versus placebo. In summary, tedizolid is a weak, reversible inhibitor of MAO-A and MAO-Bin vitro. Provocative testing in humans and animal models failed to uncover significant signals that would suggest potential for hypertensive or serotonergic adverse consequences at the therapeutic dose of tedizolid phosphate. Clinical studies are registered atwww.clinicaltrials.govas NCT01539473 (tyramine interaction study conducted at Covance Clinical Research Center, Evansville, IN) and NCT01577459 (pseudoephedrine interaction study conducted at Vince and Associates Clinical Research, Overland Park, KS).

Focus on the therapeutic efficacy of 3BNC117 against HIV-1: In vitro studies, in vivo studies, clinical trials and challenges

2017 ◽  
Vol 52 ◽  
pp. 44-50 ◽  
Author(s):  
Zhi-Jun Liu ◽  
Jing Bai ◽  
Feng-Li Liu ◽  
Xiang-Yang Zhang ◽  
Jing-Zhang Wang
Keyword(s):  
Clinical Trials ◽  
Therapeutic Efficacy ◽  
In Vitro Studies ◽  
In Vivo Studies ◽  
Hiv 1

scholarly journals Implementing Curcumin in Translational Oncology Research

Molecules ◽  
2020 ◽  
Vol 25 (22) ◽  
pp. 5240
Author(s):  
Koraljka Gall Trošelj ◽  
Ivana Samaržija ◽  
Marko Tomljanović ◽  
Renata Novak Kujundžić ◽  
Nikola Đaković ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Metabolic Reprogramming ◽  
Current Status ◽  
Strong Indication ◽  
Experimental Animals ◽  
Oncology Research ◽  
Modifying Effect ◽  
Detailed Presentation

Most data published on curcumin and curcumin-based formulations are very promising. In cancer research, the majority of data has been obtained in vitro. Less frequently, researchers used experimental animals. The results of several clinical studies are conclusive, and these studies have established a good foundation for further research focusing on implementing curcumin in clinical oncology. However, the issues regarding timely data reporting and lack of disclosure of the exact curcumin formulations used in these studies should not be neglected. This article is a snapshot of the current status of publicly available data on curcumin clinical trials and a detailed presentation of results obtained so far with some curcumin formulations. Phenomena related to the observed effects of curcumin shown in clinical trials are presented, and its modifying effect on gut microbiota and metabolic reprogramming is discussed. Based on available data, there is a strong indication that curcumin and its metabolites present molecules that do not necessarily need to be abundant in order to act locally and benefit systemically. Future clinical studies should be designed in a way that will take that fact into consideration.

scholarly journals Recent Advances in the Use of Metformin: Can Treating Diabetes Prevent Breast Cancer?

2015 ◽  
Vol 2015 ◽  
pp. 1-13 ◽  
Author(s):  
Diana Hatoum ◽  
Eileen M. McGowan
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Clinical Trial Data ◽  
The Elderly ◽  
Diabetic Patients ◽  
Positive Trend ◽  
Patients With Diabetes ◽  
Meta Analyses

There is substantial epidemiological evidence pointing to an increased incidence of breast cancer and morbidity in obese, prediabetic, and diabetic patients.In vitrostudies strongly support metformin, a diabetic medication, in breast cancer therapy. Although metformin has been heralded as an exciting new breast cancer treatment, the principal consideration is whether metformin can be used as a generic treatment for all breast cancer types. Importantly, will metformin be useful as an inexpensive therapy for patients with comorbidity of diabetes and breast cancer? In general, meta-analyses of clinical trial data from retrospective studies in which metformin treatment has been used for patients with diabetes and breast cancer have a positive trend; nevertheless, the supporting clinical data outcomes remain inconclusive. The heterogeneity of breast cancer, confounded by comorbidity of disease in the elderly population, makes it difficult to determine the actual benefits of metformin therapy. Despite the questionable evidence available from observational clinical studies and meta-analyses, randomized phases I–III clinical trials are ongoing to test the efficacy of metformin for breast cancer. This special issue review will focus on recent research, highlightingin vitroresearch and retrospective observational clinical studies and current clinical trials on metformin action in breast cancer.

Clinically relevant concentrations of opioids for in vitro studies

2016 ◽  
Vol 12 (5) ◽  
pp. 313 ◽  
Author(s):  
Jason W. Boland, FRCP, PhD ◽  
A. Graham Pockley, PhD
Keyword(s):  
Patient Group ◽  
Clinical Setting ◽  
Clinical Studies ◽  
Large Range ◽  
In Vitro Studies ◽  
Clinical Effects ◽  
Clinical Context ◽  
Patient Groups

Objectives: Numerous in vitro studies have evaluated the influence of opioids on many biological and immunological processes. The concentrations that have been used in these studies span a large range and often do not reflect levels that are present in the relevant patient groups. This article reviews the literature concerning the concentrations of opioids that are detected in patients so that the concentrations of opioids that are used for in vitro studies can better reflect those that are present clinically. This will enable scientists and clinicians to more effectively model and interpret potentially relevant clinical effects from in vitro studies.Methods: Data on the concentrations of six commonly used opioids from clinical studies in adults were collected by searching PubMed (Medline).Results: A total of 42 relevant studies were included in the review. Concentrations of the opioids from previous clinical studies were mostly between 1 and 10 ng/mL for buprenorphine, 1 and 10 ng/mL for fentanyl, 50 and 500 ng/mL for methadone, 25 and 250 ng/mL for morphine, 10 and 100 ng/mL for oxycodone, and 100 and 1,000 ng/mL for Tramadol and were dependent on the patient group and indication under investigation.Conclusions: Concentrations of opioids used in vitro should include those that are present in the relevant clinical setting if the effects of opioids detected in vitro are to be of potential relevance to the clinical setting. Therefore, it is essential that these concentrations in the relevant clinical context(s) are known.

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

scholarly journals Primary tooth pulpectomy overfilling by different placement techniques: A systematic review and meta-analysis

2020 ◽  
Vol 14 (4) ◽  
pp. 250-261
Author(s):  
Naser Asl Aminabadi ◽  
Nahid Asl Aminabad ◽  
Zahra Jamali ◽  
Sajjad Shirazi
Keyword(s):  
Calcium Hydroxide ◽  
Clinical Studies ◽  
English Language ◽  
Data Extraction ◽  
Meta Analysis ◽  
In Vitro Studies ◽  
Primary Tooth ◽  
Eligibility Criteria ◽  
Data Extraction Form

Background. This study was conducted to investigate root canal overfilling with different material placement techniques in primary teeth. Methods. A systematic search was undertaken by searching PubMed/MEDLINE and Scopus for English language peer-reviewed articles published until February 2018 that reported primary tooth pulpectomy overfilling. Two reviewers independently screened and identified studies in terms of the selection criteria and independently collected the data using a specially designed data extraction form. The overfilling rate was the primary summary measure. The weighted pooled overfilling rates were estimated by random-effects meta-analysis. Results. Twenty clinical and four in vitro studies met the eligibility criteria. In the clinical studies, the pooled overfilling rate for zinc oxide-eugenol (ZOE) was 23.3% with a lentulo spiral mounted on a handpiece, 22.7% with a hand-held lentulo spiral, and 17% with a plugger. The pooled overfilling rate for calcium hydroxide-based materials was 16.7% with a lentulo spiral mounted on a handpiece, 14.7% with a hand-held lentulo spiral, 19.6% with a syringe, and 25.7% with a plugger. In the in vitro studies, neither individual overfilling rates nor two-by-two comparisons were subjected to meta-analysis because of an inadequate number of studies. Conclusion. The lowest overfilling rate in the clinical studies was related to plugger and handheld lentulo spiral techniques for ZOE and calcium hydroxide-based materials, respectively

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