Registration of clinical trials in Russia: How does it compare with the World Health Organization International Clinical Trials Registry Platform standards?

2021 ◽  
pp. 174077452110039
Author(s):  
Dilyara Nurkhametova ◽  
Ghassan Karam ◽  
Liliya Eugenevna Ziganshina
Keyword(s):  
Clinical Trials ◽  
World Health Organization ◽  
World Health ◽  
The World ◽  
Health Organization ◽  
Clinical Trials Registry

scholarly journals Clinical outcomes of women with COVID 19 during pregnancy: an update

2020 ◽  
pp. 93-102
Author(s):  
Naushaba Tarannum Mahtab ◽  
Tanzeem Sabina Chowdhury
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
World Health Organization ◽  
Clinical Outcomes ◽  
Vulnerable Population ◽  
World Health ◽  
Unknown Etiology ◽  
Evidence Based ◽  
The World ◽  
Health Organization

In December 2019, a cluster of four cases of pneumonia of unknown etiology in Wuhan, China, were reported to the World Health Organization (WHO). Since then, the world has seen unprecedented effects of this virus on our health and life in general and every country of the world has been affected. Pregnant women are considered the most vulnerable population and clinical trials and research are going on to ensure the safety of mother and the fetus during this pandemic. The data regarding management of pregnancy during COVID-19 era is evolving every day. In this review, we evaluate the recent evidence of the effects of SARS-CoV-2 infection throughout pregnancy and provide a balanced and informed evidence-based management of pregnancy during the COVID- 19 era. Birdem Med J 2020; 10, COVID Supplement: 93-102

scholarly journals Clinical pharmacology - one of the world health organization strategies in promoting rational use of medicines

2012 ◽  
Vol 93 (6) ◽  
pp. 916-920
Author(s):  
L Y Shaydullina ◽  
L E Ziganshina
Keyword(s):  
Clinical Pharmacology ◽  
Clinical Trials ◽  
World Health Organization ◽  
Healthcare System ◽  
World Health ◽  
Current Status ◽  
Rational Use ◽  
Rational Use Of Medicines ◽  
The World ◽  
Health Organization

The review covers the history of Clinical Pharmacology discipline origin from the thirties of the twentieth century until now. Establishment of the research group on clinical pharmacology by the World Health Organization in 1969 is surveyed. The current status of clinical pharmacology in Russia is described with emphasis on potential impact of the discipline on health system in the rational use of medicines and access to medicines. The connection between clinical pharmacology development and pharmaceutical regulation and «thalidomide tragedy» of the sixties is traced. The main developing sections of the discipline of Clinical Pharmacology: pharmacoepidemiology, pharmacoeconomics, pharmacogenetics, pharmacovigilance and drug clinical trials are presented. The objectives and phases of clinical trials, the current problems of their conduction - global and Russian - are presented. Perspectives for the clinical pharmacology development using the evidence-based medicine approach are reviewed. Review reveals the multidisciplinary nature of clinical pharmacology, its bridging role between the fundamental and practical clinical disciplines, and a close connection with the development of healthcare system. Problems of clinical pharmacologists’ training and employment are discussed. The review presents the current status and development of the discipline in different countries and in the Russian Federation with reference to the federal regulations and laws. The potential of clinical pharmacology as a research, teaching and practicing medical discipline allowing the healthcare system to ensure the rational use of medicines providing drug efficiency, safety and affordability for the population is described. The results of the own authors’ research of the impact of clinical pharmacology services introduction in the practice of internal diseases departments of Kazan municipal hospitals on the outcome of coronary heart disease are presented with consideration of the various confounding factors. Review explains the need for wide use of clinical pharmacology potentials on all levels of healthcare system, particularly for administrative decision-making

scholarly journals Chemical and Mechanical Actions of Drugs Active Group Used in COVID-19 Treatment

2021 ◽  
pp. 229-237
Author(s):  
Suhayla K. Mohammed ◽  
Mzahim M. Taha ◽  
Ekhlass M. Taha
Keyword(s):  
Clinical Trials ◽  
Severe Acute Respiratory Syndrome ◽  
World Health Organization ◽  
Mechanism Of Action ◽  
Alpha Interferon ◽  
World Health ◽  
The Novel ◽  
Viral Membrane ◽  
The World ◽  
Health Organization

With the new global outbreak of the novel COVID-19, control and treatment has become critical. There is no medication proven to be effective for the treatment of severe acute respiratory syndrome which is caused by COVID-19 according to the World Health Organization (WHO) reports. Most studies that have been done on this time are clinical trials. Those studies used several drugs like lopinavir, ritonavir, nebulized alpha-interferon and, aminoquinolines. The mechanism of action is not well known so far. This review studies the metabolites of the tested drugs with different kinds of the viral membrane which merging proteins based on mechanical criteria.

scholarly journals Clinical trials in the time of a pandemic

2020 ◽  
Vol 17 (5) ◽  
pp. 467-471 ◽  
Author(s):  
Susan S Ellenberg
Keyword(s):  
Clinical Trials ◽  
World Health Organization ◽  
Vaccine Development ◽  
World Health ◽  
Severity Of Disease ◽  
The Past ◽  
The World ◽  
Global Spread ◽  
Severity Of The Disease ◽  
Health Organization

The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002–2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.

scholarly journals Medical and Dietary Uses of N-Acetylcysteine

Antioxidants ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 111 ◽  
Author(s):  
Špela Šalamon ◽  
Barbara Kramar ◽  
Tinkara Pirc Marolt ◽  
Borut Poljšak ◽  
Irina Milisav
Keyword(s):  
Clinical Trials ◽  
World Health Organization ◽  
Dietary Supplement ◽  
Global Market ◽  
Essential Medicines ◽  
World Health ◽  
Clinical Investigations ◽  
The World ◽  
The 1960S ◽  
Health Organization

N-acetylcysteine (NAC), a plant antioxidant naturally found in onion, is a precursor to glutathione. It has been used as a drug since the 1960s and is listed on the World Health Organization (WHO) Model List of Essential Medicines as an antidote in poisonings. There are numerous other uses or proposed uses in medicine that are still in preclinical and clinical investigations. NAC is also used in food supplements and cosmetics. Despite its abundant use, there are projections that the NAC global market will grow in the next five years; therefore, the purpose of this work is to provide a balanced view of further uses of NAC as a dietary supplement. Although NAC is considered a safe substance, the results among clinical trials are sometimes controversial or incomplete, like for many other antioxidants. More clinical trials are underway that will improve our understanding of NAC applicability.

Current Drug Trends for the Treatment of SARS-CoV-2

Coronaviruses ◽  
2020 ◽  
Vol 01 ◽  
Author(s):  
Márcio Robert Mattos da Silva ◽  
Melanie Tavares ◽  
Ralph Santos-Oliveira ◽  
Eduardo RicciJúnior
Keyword(s):  
Clinical Trials ◽  
World Health Organization ◽  
Molecular Modelling ◽  
Current Trend ◽  
In Vitro Studies ◽  
World Health ◽  
The World ◽  
Health Organization ◽  
Positive Results

Background: Severe Acute Respiratory Syndrome Coronavirus 2, initially first appeared in China and spread rapidly around the world, causing a pandemic. Due to the absence of an effective vaccine, many drugs have been extensively studied for the treatment of SARS-CoV-2. Objective: The aim of this work is to provide a current trend of potential drugs for the treatment of SARS-CoV-2, through literature research over drug repositioning. Methods: A literature review was performed on databases such as PubMed, ScienceDirect, Scielo, Lilacs, World Health Organization and Clinical Trials to identify relevant articles of drugs used for the treatment of SARS-CoV-2 since 2003 up to 2020. Results and Discussion : Nelfinavir presented favorable results in molecular modelling and in vitro studies. Hydroxychloroquine and Chloroquine showed positive results, nevertheless, the World Health Organization discontinued the clinical trials because these drugs might increase the frequency of ventricular arrhythmias. Darunavir and Ribavirin presented one positive and negative result for molecular modelling and in vitro studies, respectively. The combination of Lopinavir/Ritonavir and Umifenovir alone demonstrated negative results in the clinical trials performed. Remdesivir was the major drug tested which presented more positive results. Conclusion: The data do not support the use of Lopinavir/Ritonavir and Umifenovir with the potential for treatment against SARS-CoV-2. Nelfinavir has potential to be explored against SARS-CoV-2. Due to the union of several positive results obtained from studies against SARS-CoV-2, the Remdesivir should be explored as the most effective drug for the potential treatment against this virus.

High-dose or multi-day praziquantel for imported schistosomiasis? A systematic review

2019 ◽  
Vol 26 (7) ◽  
Author(s):  
Giulia Cucchetto ◽  
Dora Buonfrate ◽  
Valentina Marchese ◽  
Paola Rodari ◽  
Anna Ferrari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
World Health Organization ◽  
Case Reports ◽  
Case Series ◽  
Sub Saharan Africa ◽  
World Health ◽  
The World ◽  
Endemic Areas ◽  
Health Organization

Abstract Background Schistosomiasis affects more than 260 million people worldwide, mostly in sub-Saharan Africa, where more than 280 000 deaths per year are estimated. In the past few years, the increasing flow of migrants from endemic areas and the upward number of international travels have caused the emergence of the disease also in non-endemic areas. A single course of praziquantel (PZQ) 40 mg/kg is the first-line treatment recommended by the World Health Organization, mainly based on clinical trials conducted in endemic countries. No trials have been performed in non-endemic areas. Methods We carried out a systematic review of case reports and case series published between 1956 and August 2017 on cases of chronic schistosomiasis (infection acquired >3 months before) diagnosed in non-endemic areas and treated with PZQ. Primary outcome was to assess the number of different therapeutic regimens deployed and their frequency of use, calculated as the number of reports for each regimen over the total number of included cases. Results The final database included 99 case reports and 51 case series, for a total of 1433 patients. In 57 of the 150 records (38%) the administered treatment was different from the one recommended by the World Health Organization. The proportion of ‘alternative’ regimens included increased doses of PZQ (up to 80 mg/kg) and/or prolonged duration of treatment and/or doses repeated some days/weeks apart. About 50% of the records regarding Western short-term travellers reported a non-standard treatment. Conclusion This is the first complete catalogue of the published experience with PZQ outside of endemic areas in the situation where reinfection is not an issue. We found a wide heterogeneity of the therapeutic regimens reported. Multicenter clinical trials conducted in non-endemic areas and guidelines specifically addressing the treatment of imported cases of chronic schistosomiasis are needed.

scholarly journals DETAILED INFORMATION ON FAVIPIRAVIR: DRUG FOR TREATMENT OF SARS-COV-2

2020 ◽  
pp. 13-17
Author(s):  
MONAJI SANJANA REDDY
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Severe Acute Respiratory Syndrome ◽  
World Health Organization ◽  
Respiratory Illness ◽  
World Health ◽  
Genetic Mutations ◽  
Corona Virus ◽  
The World ◽  
Health Organization

Severe acute respiratory syndrome corona virus-2 (SARS-CoV-2) is another name given to pandemic disease COVID-19 that is caused by a newly discovered coronavirus. People infected with coronavirus will experience mild-to-moderate respiratory illness, and it can be seen in a serious stage when comorbidities include along with it. This is now creating a huge pandemic situation all over the world with a huge rate of sufferers, that is, around 9.06 million around the world and about 440 k in India till today according to the World Health Organization. This is a serious condition that should be solved with vaccine only as coronavirus is undergoing mutation it makes difficult to invent a vaccine for it. So far, about 200 genetic mutations have been discovered across the world also in these 198 mutations appeared independently more than once. Due to this pandemic situation, there are so many clinical trials going on in discovering vaccines. Recently, after many trails conducting favipiravir are found to be the most successful in treating any stage of SARS-CoV-2. This article focuses completely on this area, along with its mechanism, side effects, uses, and contraindications.

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