Document No. : FDA/SMC/CTD/GL-CCT/2013/01
Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.
The Solidarity Trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By... enrolling patients in multiple countries, the Solidarity Trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.
Until there is sufficient evidence, WHO cautions against physicians and medical associations recommending or administering these unproven treatments to patients with COVID-19 or people self-medicating with them. WHO is concerned by reports of individuals self-medicating with chloroquine and causing themselves serious harm.
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Supplement Article
www.jaids.com J Acquir Immune Defic Syndr Volume 78, Supplement 1, August 15, 2018
A Guide For Multicentre Trials in High-Burden Countries
The report presents current information (updated to September 2015) on candidate vaccines, therapies and medical devices for Ebola and gives an overview of completed and on-going trials.
August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical trials is an essential step to ensure that sufficient data is generated on the safety and efficac...y of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
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Review Article: Journal of Nutritional Health & Food Science
Vitamin Deficiency and Tuberculosis: Need for Urgent Clinical Page 1- 6
Cognitive deficits in schizophrenia can massively impact functionality and quality of life, furthering the importance of cognitive training. Despite the development of the field in Europe and in the United States, no programmes have been developed and tested in developing countries. Different cultur...al backgrounds, budget restrictions, and other difficulties may render treatment packages created in high income countries difficult for adoption by developing nations. We performed a pilot double-blind, randomized, controlled trial in order to investigate the efficacy and feasibility of an attention and memory training programme specially created in
a developing nation. The intervention used simple, widely available materials, required minimal infrastructure, and was conducted in groups.The sample included seventeen stable Brazilians with schizophrenia. Sessions were conducted weekly during five months. The cognitive training group showed significant improvements in inhibitory control and set-shifting over time. Both groups showed improvements in symptoms, processing speed, selective attention, executive function, and long-term visual memory. Improvements were found in the control group in long-term verbal memory and concentration. Our findings reinforce the idea that cognitive training in schizophrenia can be constructed using simple resources and infrastructure, facilitating its adoption by developing countries, and it may improve cognition.
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Supplement Article
J Acquir Immune Defic Syndr Volume 78, Supplement 1, August 15, 2018 www.jaids.com
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Clinical Medicine
JCI Insight. 2017;2(7):e91963.
A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to
Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited d...ata on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (I MPAMEL III) in T.b. rhodesiense endemic areas of
Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa.
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Learn what scientists look for in the different phases of a clinical trial for a vaccine. What does it mean when a vaccine trial is halted due to an adverse event? WHO’s Dr Kate O’Brien explains in Science in 5 this week