WHO and UNITAID
in collaboration with IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) network, PENTA (Paediatric European Network for Treatment of AIDS) foundation and experts from the Paediatric Antiretroviral Working Group
Miscellaneous
Chapter J.7
Research Article
Received: August 21, 2017; Accepted: August 29, 2017; Published: Spetember 05,
2017
This article is available in: http://www.imedpub.com/advanced-techniques-in-clinical-microbiology/
Supplement Article
J Acquir Immune Defic Syndr Volume 78, Supplement 1, August 15, 2018 www.jaids.com
The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Repub...lic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.
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Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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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.
This research aims to identify a core set of clinical skills for working in
a Community Based Rehabilitation (CBR) setting, and to discuss whether they are appropriate for task shifting to a new or an alternative cadre of rehabilitation workers.
Robust clinical research capacity in low- and middle-income countries is key to stemming the spread of epidemics, according to a new report from the International Vaccines Task Force (IVTF). The report lays out how to develop the political support, financing and coordination required to build this c...apacity as a crucial component of global epidemic preparedness. The IVTF was convened by the World Bank Group (WBG) and the Coalition for Epidemic Preparedness Innovations (CEPI) in October 2017.
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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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Awareness of autism has grown monumentally over the past 20 years. Yet, this increased awareness has not been accompanied by improvements in services to support autistic individuals and their families. Many fundamental questions remain about the care of people with autism—including which intervent...ions are effective, for whom, when, and at what intensity. The Lancet Commission on the future of care and clinical research in autism aims to answer the question of what can be done in the next 5 years to address the current needs of autistic individuals and families worldwide.
Here you can download the articles and comments.
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The roadmap describes the actions needed to
achieve the three development goals for TB
vaccines set by the WHO:
1. A safe, effective and affordable TB vaccine
for adolescents and adults.
2. An affordable TB vaccine for neonates and
infants with improved safety and efficacy.
3. A therapeutic v...accine to improve TB
treatment outcomes
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Pathogens . 2021 Nov 16;10(11):1493.doi: 10.3390/pathogens10111493
.Chronic manifestations of Chagas disease present as disabling and life-threatening condi-tions affecting mainly the cardiovascular and gastrointestinal systems. Although meaningful research has outlined the different molecular mech...anisms underlying Trypanosoma cruzi’s infection and the host-parasite interactions that follow, prompt diagnosis and treatment remain a challenge, particu-larly in developing countries and also in those where the disease is considered non-endemic. This review intends to present an up-to-date review of the parasite’s life cycle, genetic diversity, virulence factors, and infective mechanisms, as well as the epidemiology, clinical presentation, diagnosis, and treatment options of the main chronic complications of Chagas disease.
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Research and Reports in Tropical Medicine 2022:13 25–40
Chagas disease (CD) or American trypanosomiasis is a neglected parasitic disease associated with significant mortality and morbidity that includes long-term disability, social stigma and a mental health toll. Perceived as a disease of the ve...ry poor, this infection, once limited to rural areas of Latin America (LA), has now spread via migration to non-endemic areas and countries, where transmission is maintained via non-vectorial routes.
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To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for evaluation and development of new treatments for Chagas disease. The patient-centred platform aims to f...acilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy and reviews alternatives for using current approved drugs (new schemes, doses, combination) and special scenarios (resistance).
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Chagas disease (CD) is caused by the parasite Trypanosoma cruzi, and it is endemic in Central, South America, Mexico and the
South of the United States. It is an important cause of early mortality and morbidity, and it is associated with poverty and stigma. A third of
the cases evolve into chronic... cardiomyopathy and gastrointestinal disease. The infection is transmitted vertically and by blood/organ
donation and can reactivate with immunosuppression. Case identification requires awareness and screening programmes targeting the
population at risk (women in reproductive age, donors, immunocompromised patients). Treatment with benznidazole or nifurtimox is most
effective in the acute phase and prevents progression to chronic phase when given to children. Treating women antenatally reduces but does
not eliminate vertical transmission. Treatment is poorly tolerated, contraindicated during pregnancy, and has little effect modifying the
disease in the chronic phase. Screening is easily performed with serology. Migration has brought the disease outside of the endemic
countries, where the transmission continues vertically and via blood and tissue/organ donations. There are more than 32 million migrants
from Latin America living in non-endemic countries. However, the infection is massively underdiagnosed in this setting due to the lack of
awareness by patients, health authorities and professionals. Blood and tissue donation screening policies have significantly reduced
transmission in endemic countries but are not universally established in the non-endemic setting. Antenatal screening is not commonly
done. Other challenges include difficulties accessing and retaining patients in the healthcare system and lack of specific funding for the
interventions. Any strategy must be accompanied by education and awareness campaigns directed to patients, professionals and policy
makers. The involvement of patients and their communities is central and key for success and must be sought early and actively. This review
proposes strategies to address challenges faced by non-endemic countries
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Most neglected tropical diseases (NTDs) occur in remote areas of low- and middle-income countries, where health systems are often poorly developed. Therefore, these neglected patients generally lack access to quality preventive, diagnostic, and therapeutic care [1]. The difficulty to access NTD-ende...mic areas, challenging logistics, and the lack of skilled human resources in these areas are also major obstacles to conduct clinical research. We had to face these when conducting a good clinical practice/good clinical laboratory practice (GCP/GCLP)-compliant clinical study in eastern Sudan, a well-known endemic area for visceral leishmaniasis and other NTDs. We share here the challenges related to study preparation and implementation of this GCP/GCLP study that investigated the causes of persistent fever in a rural hospital located in Gedaref State in eastern Sudan. We think this type of paper may be of interest for researchers planning to conduct a clinical trial in a resource-limited setting as well as for funders of such research.
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As of 12 December 2022, over 645 million people worldwide have been diagnosed with COVID-19, with over 6.6 million deaths (4).
The Omicron variant, which emerged in late November 2021, and its subvariants, are now the dominant circulating viruses, contributing to the ongoing surge in several countr...ies (4). Vaccination has substantially reduced case numbers and hospitalizations in many countries,but limitations in global access to vaccines mean that many populations, including those in low- and middle-income countries, remain vulnerable. Even in vaccinated individuals, uncertainties remain about duration of protection and efficacy, and the degree of crossprotection with new variants.
There remains a need for more effective treatment and management for those affected by COVID-19. The pandemic – and the
explosion of both research and misinformation – has highlighted the need for trustworthy, accessible and regularly updated living
guidelines to place emerging findings into context and provide clear recommendations for clinical practice
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Chronic manifestations of Chagas disease present as disabling and life-threatening conditions affecting mainly the cardiovascular and gastrointestinal systems. Although meaningful research has outlined the different molecular mechanisms underlying Trypanosoma cruzi’s infection and the host-parasit...e interactions that follow, prompt diagnosis and treatment remain a challenge, particularly in developing countries and also in those where the disease is considered non-endemic. This review intends to present an up-to-date review of the parasite’s life cycle, genetic diversity, virulence
factors, and infective mechanisms, as well as the epidemiology, clinical presentation, diagnosis, and treatment options of the main chronic complications of Chagas disease.
more