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Southern Clinical Regulatory PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Southern Clinical Regulatory articles that have been published worldwide.
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The "Parallel regulatory-HTA SA" (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and HTA bodies on development plans for new medicines.
Quantification of regulatory T cells is crucial in immunomonitoring in clinical trials as this cell population has been shown to be involved in a wide range of diseases, including cancers, autoimmune diseases, infections and allergies. Human regulatory T cells are defined as CD4+ CD25+ CD127low FoxP3+ cells, and the standardization of their staining by flow cytometry is a challenge, especially in multicenter clinical trials, notably because of the intracellular location of FoxP3.
Clinical risk factors for fracture in Southern Brazil are similar to those used in Fracture Risk Assessment Tool (FRAX®). Age-dependent intervention thresholds had higher accuracy than a fixed cut-off point.
To evaluate the prevalence and the characteristics of jaw lesions diagnosed in young adults aged 20 to 30 years in a southern Brazil reference center, over a period of 25 years. And to analyze the concordance between clinical and histological diagnosis.
To investigate the epidemiology of type 1 diabetes mellitus (T1DM) in Basrah city, Southern Iraq, between 2012 and 2016 among people 0-40year old.
We have previously shown that mast cells (MCs) suppress chronic allergic dermatitis in mice. The underlying mechanism involves MC-derived IL-2, which supports regulatory T cell (Treg) response at the site of inflammation. However, it is not clear what are the factors that drive MCs to produce IL-2.
The Zika outbreak that began in 2015 has spread from Brazil to countries across the Western Hemisphere including the United States, presenting global public health challenges that call for the expedited development and availability of preventive vaccines to protect against Zika virus disease. While the general principles guiding the nonclinical and clinical development for Zika vaccines are the same as those of other preventive vaccines, unique considerations apply, in particular if development occurs durin...
The application of regulatory T cell (Treg) therapy in organ transplantation is actively being pursued using unmodified, typically polyclonal cells. As the results of these ongoing clinical trials emerge, it is time to plan the next wave of clinical trials of Tregs. Here we will review a key strategy to improve Treg effectiveness and reduce side effects, namely increasing Treg specificity - both in terms of antigen recognition and localization to the allograft.
Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies...
DNA methylation contains information about the regulatory state of the cell. MIRA aggregates genome-scale DNA methylation data into a DNA methylation profile for independent region sets with shared biological annotation. Using this profile, MIRA infers and scores the collective regulatory activity for each region set. MIRA facilitates regulatory analysis in situations where classical regulatory assays would be difficult and allows public sources of open chromatin and protein binding regions to be leveraged ...
Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available fro...
Regulatory T cells (Tregs) are critical mediators of immune homeostasis and hold significant promise in the quest for transplantation tolerance. Progress has now reached a critical threshold as techniques for production of clinical therapies are optimised and Phase I/II clinical trials are in full swing. Initial safety and efficacy data are being reported, with trials assessing a number of different strategies for the introduction of Treg therapy. It is now more crucial than ever to elucidate further the fu...
Psychedelics comprise drugs come from various pharmacological classes including 5-HT2A agonists, indirect 5-HT agonists, e.g. MDMA, NMDA antagonists and κ-opioid receptor agonists. There is resurgence in developing psychedelics to treat psychiatric disorders with high unmet clinical need. Many, but not all, psychedelics are schedule 1 controlled drugs (CDs), i.e. no approved medical use. For existing psychedelics in development, regulatory approval will require a move from schedule 1 to a CD schedule for d...
Southern Africa (South Africa as well as neighboring countries) has not had an infrastructure for testing the safety of new drugs or other therapeutic entities, including plant-based or herbal treatments coming from the indigenous cultures, according to the current practice and regulatory requirements. Simultaneously, Southern Africa is challenged by very high rates of immune deficiency diseases which have further led to the resurgence of diseases such as tuberculosis, which is commonly thought to be eradic...
Local allergic rhinitis (LAR) is characterized by the production of specific IgE (sIgE) in the nasal mucosa without evidence of systemic atopy. The characteristics of LAR in Caucasians have been well documented. LAR is understudied in China, with prevalence, patient demographics, symptomatology, and the allergen sensitization profile being poorly understood. The purpose of this study is to investigate the demographics, characteristics, and allergen sensitization profile of patients with LAR in Southern Chin...
Primaquine is the only licensed drug for eradicating Plasmodium vivax hypnozoites and, therefore, preventing relapses of vivax malaria. It is a vital component of global malaria elimination efforts. Primaquine is efficacious when supervised in clinical trials, but its effectiveness in real-world settings is unknown. We aimed to determine whether unsupervised primaquine was effective for preventing re-presentation to hospital with vivax malaria in southern Papua, Indonesia.
Regulatory macrophages play a critical role in tissue repair and we have previously shown that anti-TNF antibodies induce these macrophages in vitro and in vivo in IBD patients. The induction of regulatory macrophages can be potentiated using the combination of anti-TNF and thiopurines, consistent with the enhanced efficacy of this combination therapy described in clinical trials. As thiopurines are unfortunately associated with significant side effects, we here aimed to identify alternatives for combinatio...
In southern Malawi, 12.8% of adults are HIV positive. Men are less likely to have been tested than women. We investigated men's HIV knowledge and the attitudes, influencers, facilitators and barriers affecting HIV testing.
Despite their growing prevalence, pelvic floor disorders (PFDs) remain undertreated and not well understood by patients, with treatment disparities noted in specific subgroups of women. The goal of the present study was to determine the basic understanding of PFDs of women in the southern Appalachian region of the United States, to determine factors that predict knowledge, and to explore the possible disparities in seeking access to care among women in this region who reported symptoms.