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As vaccines get approved by national authorities, learn about National and WHO approval processes for vaccines and how safety is ensured during emergency approval of vaccines. Dr Mariângela Simão
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explains in Science in 5.
more
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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As vaccines get approved by national authorities, learn about National and WHO approval processes for vaccines and how safety is ensured during emergency approval of vaccines. Dr Mariângela Simão
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explains in Science in 5.
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Scientists and researchers managed to produce vaccines to protect against COVID-19. Vaccine candidates have recently been approved in some countries and are in the approval process in others, yet misinformation about the safety and effects of any fu
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ture vaccine is already threatening its rollout. In this report, we catalogue the top myths about a COVID-19 vaccine that have appeared in NewsGuard’s ratings of more than 6,000 news and information sites worldwide.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure
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or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Patents and licences on antiretrovirals: A snapshot
UNITAID; WHO
(2014)
The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those
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ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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Serology-based tests for COVID-19
recommended
This page serves to provide up to date information on serology tests that are in development or available for use. Importantly, many of these tests have been approved for research use only, which indicates that they are not yet approved for use as a public health diagnostic tool or for at-home diagn
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osis. Some of these tests may move forward to approval for diagnostic use, while others may be appropriate for research only.
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COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h
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igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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In view of the ongoing political, peace and reconciliation, administrative and economic reforms as well as plans to establish the United Nations Development Assistance Framework (UNDAF) in 2018, WFP extended the current Protracted Relief and Recovery Operation (PRRO 200299), launched in January 2
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013, by two years to include 2016 and 2017, with approved budget USD 343 million. To echo this extension and provide a more appropriate response to the country's rapid and multi-pronged transition, WFP adopted a transition strategy with gradually reduced emphasis on humanitarian assistance and greater focus on early recovery and development interventions. WFP's strategic engagement in-country was driven by the overarching goal to assist Myanmar to achieve the national Zero Hunger Challenge by 2025, and was guided by three priorities: emergency preparedness and response; nutrition; and provision of social safety nets.
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Antimicrobial resistance has become one of the most eminent threats to global health and a rising concern for healthcare specialists. All around the world, many common infections are becoming resistant to the antimicrobial medicines used to treat them, resulting in high morbidity and mortality with
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serious social and economic implications. Additionally, there are few new antibiotics being developed but they are expensive and are not new classes. Antimicrobials are critical in the management of infectious diseases. They are also essential tools for protecting animal health and welfare, and contribute in production of safe food. Inappropriate use of antimicrobials can lead to resistance which is known as the antimicrobial resistance (AMR) resulting in high morbidity and mortality with serious social and economic implications.
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Treatment Recommendations for Adult Inpatients
A systematic approach to holistic wound care is essential for the delivery of high quality wound care. Holistic wound assessment considers the whole person and should comprise the components of the generic wound assessment minimal data set. Therefore holistic assessment is key to gathering informati
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on on the
patient and their wound. This information should be documented at each review so that it can act as a baseline against which wound progress can be tracked and used to guide management decisions.
Inaccurate or lack of assessment can result in appropriate care and delays in healing, unnecessary patient suffering, poor outcomes and the inappropriate use of resources
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This guidance package compiles current facts and key messages about the Ebola outbreak in Liberia to inform activities designed to raise awareness, mobilize communities, and promote safe behaviors to stop the spread of Ebola in Liberia.
Version 3
Updates:
• Safe School reopening
• Special Events messages for sporting events and Africa Cup of Nations,
Elections and public gatherings and holidays
• Safe sex and condom use for Survivors
• Cemetery messages
The purpose of this guidance package is to provide government a
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gencies, response committees and teams, media outlets, partners, and community leaders with accurate and consistent information to use for when communicating about Ebola in Liberia. All are encouraged to share this document widely as a guide for all communicating about Ebola
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A Capstone Project submitted in partial fulfillment of the requirements for the Master of Science Degree in Counselor Education at Winona State University | This article reviews the use of Art Therapy to treat children who suffer from Posttraumatic Stress Disorder. It explores the clinical need for
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addressing trauma, including PTSD, and then reviews the effects of trauma on the brain, and how Art Therapy affects the brain. It also identifies mental health characteristics and needs for children diagnosed with PTSD.
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Needs and barriers for mental health and psychosocial support among syrian refugees in lebanon: perspectives for future interventions
European Union Civil protection and Humanitarian Aid
European Union Civil protection and Humanitarian Aid
(2018)
CC
Results
Recommendations• NGOs should provide MHPSS services with a focus on empowerment and self-reliance
• Introduce interventions focusing on pain mechanisms, coping strategies and physical resilience
• Implement livelihood programmes
• Increase service accessibility and outreach activ
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ities
• Provide support groups for people who have lost a close family member
• Highlight the importance of supervision and training
• Ensure high quality service provisions by applying relevant outcome measures and to further contribute to the evidence base for MHPSS
• Diversify MHPSS activities to different target groups, including men and women, and address the needs of elderly and individuals with disabilities
This study provides evidence of a large gap between the need of MHPSS among Syrian refugees and provided services. Of the 1082 respondents in this study, 62% expressed that they needed assistance to deal with physical pain and distress. Almost 80% reported being in pain, of which 27% were in severe or very severe pain. Additionally, 55% suffer from distress and 56% rate their own health as fair or poor. Even among the 18-25-yearolds, the prevalence of reporting their overall health as fair was 30.7%. For functionality levels, 28.5% felt severely or extremely emotionally affected by their health problems, and more than 20% had serious difficulties in doing day-to-day work. On the other hand, the majority (72-74%) had no problems in maintaining friendships and participating in community activities
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The WHO Framework for the clinical evaluation of devices for male circumcision
outlines a multi-phase process to ensure the safety, efficacy, and acceptability of new devices, especially for use in resource-limited settings
Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati
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ents 6 years of age and older and weighing at least 20 kg.
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)]
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This paper presents a bibliometric analysis of the literature on private health aid and official health assistance between 2000 and 2022. It provides an overview of the sites and themes in the literature pertaining to development assistance in health, and collates the significant policy recommendati
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ons presented therein. Several crucial findings emerge from the bibliometric analysis: 44.2 percent of the 489 papers/articles assessed focused on lower-middle-income countries, while 37.7 percent focused on low-income countries. However, authors affiliated with institutes and organisations from lower-middle- and low-income countries contributed merely 15.5 percent and 11.8 percent, respectively, of the papers assessed. Most (72.7 percent) were written by authors from highmiddle-
and high-income countries. Additionally, despite non-governmental
organisations, philanthropies, and private businesses constituting about 20 percent of development assistance donors, a mere 4 percent of all papers focused on these entities.
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