scholarly journals A national strategy for UK musculoskeletal clinical research: Arthritis Research UK clinical studies initiative

Rheumatology ◽  
2010 ◽  
Vol 50 (4) ◽  
pp. 640-642 ◽  
Author(s):  
A. J. Silman ◽  
S. Rudkin
Keyword(s):  
Clinical Research ◽  
Clinical Studies ◽  
National Strategy

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).

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.

Animal Models of Osteomyelitis

1988 ◽  
Vol 97 (2_suppl) ◽  
pp. 18-20
Author(s):  
Carl W. Norden
Keyword(s):  
Animal Model ◽  
Animal Models ◽  
Clinical Research ◽  
Clinical Studies ◽  
Disease Process ◽  
Controlled Experiments ◽  
Ideal Model ◽  
Treatment Protocols ◽  
Multiple Variables ◽  
The Ideal

Clinical studies of osteomyelitis are difficult because of the multiple variables found in this disease. Reproducible animal models in rabbits, rats, and dogs have been introduced and have been useful. Each animal model has certain advantages and limitations, and the ideal model is not yet available. However, the models have provided us with a clearer understanding of the disease and its treatment. Clinical research into osteomyelitis is difficult because of the multiple variables involved in the disease process and because of the difficulty of standardizing treatment protocols. To perform controlled experiments in the field of osteomyelitis, it is clear that reliable animal models are needed. Most studies have been performed with S aureus (the major pathogen isolated from patients with osteomyelitis), but other organisms have also been tested more recently.

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.

Inclusion of Children in Clinical Research: Lessons Learned From Mothers of Diabetic Children

2001 ◽  
Vol 10 (2) ◽  
pp. 140-162 ◽  
Author(s):  
Pamela K. Pletsch ◽  
Patricia E. Stevens
Keyword(s):  
Qualitative Study ◽  
Clinical Research ◽  
Clinical Studies ◽  
Lessons Learned ◽  
Diabetic Children

Nine mothers of diabetic children participated in a qualitative study about the factors that influenced them to consent to havand how they evaluated the clinical studies their children had been in. Results suggest that mothers engage in a personal calculus before making a choice to consent.

Fundamentals of Data Collection in Clinical Studies: Simple Steps to Avoid “Garbage In, Garbage Out”

2020 ◽  
pp. 153473462093823
Author(s):  
José G. B. Derraik ◽  
Wason Parklak ◽  
Benjamin B. Albert ◽  
Kongsak Boonyapranai ◽  
Kittipan Rerkasem
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Clinical Studies ◽  
Poor Quality ◽  
Early Career ◽  
High Quality ◽  
Quality Research ◽  
Early Career Researchers ◽  
Key Aspects ◽  
Collection And Management

Many fundamental steps underpin the delivery of high-quality clinical research. In this article, we provide a brief commentary on some important aspects associated with the collection and management of data during clinical studies, which, if overlooked, will lead to poor-quality research. In particular, we discuss the key aspects that should help early career researchers maximize the relevance and impact of their clinical research.

scholarly journals Scientific Trends in Clinical Research on Zirconia Dental Implants: A Bibliometric Review

Materials ◽  
2020 ◽  
Vol 13 (23) ◽  
pp. 5534
Author(s):  
Felice Lorusso ◽  
Sammy Noumbissi ◽  
Inchingolo Francesco ◽  
Biagio Rapone ◽  
Ahmad G. A. Khater ◽  
...  
Keyword(s):  
Survival Rate ◽  
Bone Loss ◽  
Clinical Research ◽  
Dental Implants ◽  
Clinical Studies ◽  
Medical Center ◽  
Marginal Bone Loss ◽  
Oral Rehabilitation ◽  
Bibliometric Review ◽  
Zirconia Implants

Background: The clinical use of zirconia implants has been shown to increase steadily due to their biological, aesthetic, and physical properties; therefore, this bibliometric study aimed to review the clinical research and co-authors in the field of zirconia dental implant rehabilitation. Methods: We searched Scopus and Web of Science databases using a comprehensive search strategy to 5 October 2020, and independently paired reviewers who screened studies, and collected data with inclusion criteria restricted to clinical research only (either prospective or retrospective). Data on article title, co-authors, number of citations received, journal details, publication year, country and institution involved, funding, study design, marginal bone loss, survival rate, failure, follow-up, and the author’s bibliometric data were collected and evaluated. Results: A total of 29 clinical studies were published between 2008 and 2020 as 41.4% were prospective cohort studies and 48.3% originated from Germany. Most of the included studies had been published in Clinical Oral Implant Research (n = 12), and the most productive institution was the Medical Center of University of Freiburg. The author with the largest number of clinical studies on zirconia implants was Kohal R.J. (n = 10), followed by Spies B.C. (n = 8). Conclusions: This study revealed that zirconia implants have been more prominent in the last ten years, which is a valuable option for oral rehabilitation with marginal bone loss and survival rate comparable to titanium dental implants.

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