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This special issue on Newborn Health in Global Health Action is being launched to share the experience of how to scale up a cost-effective package of newborn care that involves families, community health workers and health facilities. The results of this community randomized
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trial, the Uganda Newborn Study (UNEST), show that home visits in pregnancy and soon after delivery resulted in improved breastfeeding practices, skin-to-skin care immediately after birth, delaying a baby’s first bath, and hygienic care of the baby’s umbilical cord among the poorest households with lowest access to care.
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The COPSI project is divided into three phases: the first in which the intervention is developed, the second in which researchers evaluate the intervention in a randomised controlled trial, and the final one in which the results of the
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trial are analysed and disseminated.
A COPSI resource kit has been developed comprising the COPSI training manual for the community health workers, intervention flip chart, 14 intervention handouts, recovery stories booklet and videos about people with schizophrenia and their families telling their stories of illness and recovery in a deeply personal way.
To access the videos, please click to http://www.sangath.in/copsi/ to watch the video based in Tamil Nadu and to watch the video based in Maharashtra.
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COVID-19 vaccine tracker and landscape
recommended
The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-
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clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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Africa Centers for Disease Control and Prevention (Africa CDC) is aware of the media releases of the preliminary results of a large randomized clinical trial conducted in the United Kingdom, which included dexamethasone, a corticosteroid, as one of
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the drugs used for the treatment of COVID-19 patients. The investigators reported that administration of oral or injectable dexamethasone resulted in about one-third reduction in mortality among COVID-19 patientsi that required mechanical ventilation and about one-fifth for patients requiring oxygen.
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This article is part two in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. This article focuses on the ingredients in a vaccine and the three clinical
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trial phases. Part three outlines the next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution
Available in English, French, Spanish, Arabic, Chinese and Russian
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Exciting news this week with @Pfizer reporting their mRNA vaccine is 90% effective, based on their Phase III clinical trial data. Dr. Tom looks inside the virus to break down how mRNA vaccines work, and whether news this promising means we can final
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ly relax.
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This document is part three in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. Part two focused on the ingredients in a vaccine and the three clinical
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trial phases.
This document outlines the next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution.
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This article is part four in a series of explainers on vaccine development and distribution.
Part one focused on how vaccines work to protect our bodies from disease-carrying germs.
Part two focused on the ingredients in a vaccine and the three clinical
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trial phases.
Part three focused on the steps from completing the clinical trial phases through to distribution.
This document outlines the different types of vaccines.
Available in English, French, Spanisch, Arabic, Chinese and Russian
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The paper provides the rationale for these recommendations, which are based on analyses of data from the TRACT trial.
Information note. In 2021, preliminary results of observational studies from the Community Access to Rectal Artesunate for Malaria (CARAMAL) project did not confirm the mortality impact observed in the controlled trial in 2009. Consequently, in Janu
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ary 2022, WHO released an information note on rectal artesunate (RAS), suggesting immediate risk mitigation measures. To provide clarity on the evidence, WHO subsequently convened independent experts to conduct a formal evidence review of the data from the CARAMAL project, as well as data from other studies evaluating the deployment of pre-referral RAS at programmatic level
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Tsetse Control and Gambian Sleeping Sickness; Implications for Control Strategy
Tirados, I.; Esterhuizen, J.; Kovacic, V.; Mangwiro, TNC.; Vale, GA
PLOS Neglected Tropical Diseases
(2015)
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Sleeping sickness is controlled by case detection and treatment but this often only reaches less than 75% of the population. Vector control is capable of completely interrupting HAT transmission but is not used because of expense. We conducted a full scale field
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trial of a refined vector control technology. From preliminary trials we determined the number of insecticidal tiny targets required to control tsetse populations by more than 90%. We then carried out a full scale, 500 km2 field trial covering two HAT foci in Northern Uganda (overall target density 5.7/km2). In 12 months tsetse populations declined by more than 90%. A mathematical model suggested that a 72% reduction in tsetse population is required to stop transmission in those settings. The Ugandan census suggests population density in the HAT foci is approximately 500 per km2. The estimated cost for a single round of active case detection (excluding treatment), covering 80% of the population, is US$433,333 (WHO figures). One year of vector control organised within country, which can completely stop HAT transmission, would cost US$42,700. The case for adding this new method of vector control to case detection and treatment is strong. We outline how such a component could be organised.
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DOI: 10.5772/intechopen.102891Little progress has been made since the 1960s and 19. 70s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and opera
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tional challenges in the clinical drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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High levels of storage iron may increase malaria susceptibility. This risk has not been investigated in semi-immune adolescents. We investigated whether baseline iron status of nonpregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the fo
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llowing rainy season. For this prospective study, we analysed data from an interim safety survey, conducted six months into a randomised iron supplementation trial. We used logistic regression to model the risk of P. falciparum infection prevalence by microscopy, the pre-specified interim safety outcome, in relation to iron status, nutritional indicators and menarche assessed at recruitment.
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The International Classification of Functioning, Disability and Health, known more commonly as ICF, provides a standard language and framework for the description of health and health-related states. Like the first version published by the World Health Organization for
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trial purposes in 1980, ICF is a multipurpose classification intended for a wide range of uses in different sectors. It is a classification of health and health-related domains -- domains that help us to describe changes in body function and structure, what a person with a health condition can do in a standard environment (their level of capacity), as well as what they actually do in their usual environment (their level of performance).
These domains are classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. In ICF, the term functioning refers to all body functions, activities and participation, while disability is similarly an umbrella term for impairments, activity limitations and participation restrictions. ICF also lists environmental factors that interact with all these components.
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Clinical management standard operating procedures.
Ebola virus disease (EVD) is a life-threatening multisystem illness associated with fever and gastrointestinal (GI) symptoms that frequently leads to hypovolaemia, metabolic acidosis, hypoglycaemia, and multi-organ failure. The prolonged 2013–201
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6 EVD outbreak in West Africa allowed for an evolution of care such that by outbreak end many patients received individualized and optimized supportive care (oSoC), including volume resuscitation, symptom control, laboratory and bedside monitoring of glucose, electrolyte levels and organ dysfunction, as well as rapid detection and treatment of co-infections, potentially contributing to the downward trend in the case fatality rate (CFR).
This guidance should serve as a foundation for oSoC that should be followed to ensure both the best possible chance for survival and allow for reliable comparison of investigational therapeutic interventions as part of a randomized controlled trial. This guideline provides recommendations for the management of adults and children.
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Wits Reproductive Health and HIV Institute (Wits RHI) is involved in an effort to curb the COVID-19 pandemic that is facing South Africa and the world at large. Prof. Helen Rees is a member of the team advising the Health Minister on COVID-19 (MAC). She is part of the Clinicians Group, the Research
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group and the Incident Management Team (IMT). Prof. Rees is Co-Chair of the South African arm of the Solidarity study
This is a World Health Organisation (WHO) coordinated trial that will generate high quality evidence on COVID-19 treatment options. Prof Helen is also the International Coordinator for the global Crown Coronation study. This study is aimed at looking at strategies to protect healthcare workers.
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Early data from US biotech Moderna has revealed that its Covid-19 vaccine candidate is 94.5 per cent effective, raising hopes that a range of immunisations will be available to help end the pandemic.
The interim analysis of the vaccine, currently known as mRNA-1273, comes after 95
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trial participants contracted Covid-19, including just five who were given the coronavirus jab.
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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
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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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A living WHO guideline on drugs for covid-19
recommended
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE
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COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
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The Global Programme to Eliminate Lymphatic Filariasis (LF) is using mass drug administration (MDA) of antifilarial medications to treat filarial infections, prevent disease and interrupt transmission. Almost 500 million people receive these medications each year. Clinical trials have recently shown
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that a single dose of a triple-drug combination comprised of ivermectin, diethylcarbamazine and albendazole (IDA) is dramatically superior to widely used two-drug combinations for clearing larval filarial parasites from the blood of infected persons. A large mul-
ticenter community study showed that IDA was well-tolerated when it was provided as MDA. IDA was rapidly advanced from clinical trial to policy and implementation; it has the potential to accelerate LF elimination in many endemic countries.
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