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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.
We have published hundreds of Southern Clinical Regulatory news stories on BioPortfolio along with dozens of Southern Clinical Regulatory Clinical Trials and PubMed Articles about Southern Clinical Regulatory for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Southern Clinical Regulatory Companies in our database. You can also find out about relevant Southern Clinical Regulatory Drugs and Medications on this site too.
Regional variability in HIV care engagement remains underexplored. Multiple logistic models compared HIV-outcomes for participants from five Southern (n=557) and six Non-Southern sites (n=670). Southern participants had less viral suppression (aOR=0.59; 95%CI=0.43-0.82) and higher likelihood of CD4+
Current clinical experience with immunomodulatory agents and monoclonal antibodies in principle has established the benefit of depleting lymphocytic populations in relapsing-remitting multiple sclerosis (RRMS). B and T cells may exert multiple pro-inflammatory actions, but also possess regulatory functions making their role in RRMS pathogenesis much more complex. There is no clear correlation of Tregs and Bregs with clinical features of the disease. Herein, we discuss the emerging data on regulatory T and B...
The dysfunction of the immune regulatory system plays an important role in the pathogenesis of rheumatoid arthritis (RA). Vasoactive intestinal peptide (VIP) has multiple bioactivities. This study aims to investigate the role of VIP in the maintenance of the immune regulatory capacity of monocytes (Mos).
We investigated the genetic history of southern African populations with a special focus on their paternal history. We reexamined previous claims that the Y-chromosome haplogroup E1b1b (E-M293) was brought to southern Africa by pastoralists from eastern Africa, and investigated patterns of sex-biased gene flow in southern Africa.
The CO uptake by the Southern Ocean (
Immune markers in the peripheral blood of melanoma patients provide useful information for clinical management although there is poor consensus on circulating cells which could putatively reflect the disease activity and play a prognostic role. Here, we investigated both dendritic cells (DCs) and T-regulatory cells (Tregs).
To evaluate the time that residents spend on clinical computing.
In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially o...
Atrial fibrillation (AF) presents a growing clinical and public health burden for which better rhythm control therapies are needed. Focal impulse and rotor mapping (FIRM), currently marketed as part of the Topera Rotor Mapping system (Abbott Laboratories, Austin, TX), represents a potentially transformational approach to guiding the invasive treatment of AF. However, many years after its initial marketing clearance, the clinical utility of this technology remains uncertain. In this article, we review the sc...
Tumors can acquire tolerance to tumor immunity and develop enhanced proliferation. Regulatory B cells (Bregs), whose role in immune tolerance is similar to that of regulatory T cells (Tregs), appear to be involved in tumor immunity. Recently, Bregs were found to induce Tregs against tumor immunity. However, the platform for the coexistence of Bregs and Tregs in cancer patients and its clinical significance remain unclear; thus, they were evaluated in breast cancer patients.
IL-21 is a key player of adaptive immunity with well-established roles in B and cytotoxic T cell responses. IL-21 has been implicated in promotion of effector CD4 T cells and inhibition of FoxP3 regulatory T cells (Tregs), but the mechanism and functional relevance of these findings remain controversial.
Dissemination of the Methicillin Resistance Staphylococcus Aureus Pediatric Clone (ST5-T002-IV-PVL+) as a Major Cause of Community Associated Staphylococcal Infections in Bedouin Children, Southern Israel.
Pediatric community associated methicillin resistant Staphylococcus aureus (CA-MRSA) infections are emerging worldwide. High CA-MRSA carriage rates were previously described in healthy Bedouin children. We assessed demographic, clinical and molecular characteristics of pediatric MRSA infections in southern Israel.
Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Simulation is increasingly being used in product development but rarely in regulatory applications.
Model-Informed Drug Development (MIDD) refers to the application of a wide range of quantitative models in drug development to facilitate the decision-making process. MIDD was formally recognized in PDUFA VI. There have been many regulatory applications of MIDD to address a variety of drug development and regulatory questions. These applications can be broadly classified into four categories: dose optimization, supportive evidence for efficacy, clinical trial design, and informing policy. Case studies, lite...
At the turn of the century, the pharmaceutical industry began a transition toward a focus on oncology, rare diseases, and other areas of high unmet need that required a new, more complex approach to drug development. For many of these disease states and novel approaches to therapy, traditional approaches to clinical trial design fall short and a number of innovative trial designs have emerged. In light of these changes, regulators across the globe are implementing new programs to provide regular development...
Langerhans cell histiocytosis is characterized by lesions containing inflammatory immune cells, including myeloid cells and T cells. Patient mortality remains unacceptably high and new treatment options are required. Several LCH studies have identified aberrant frequencies of T cell subsets with potential immune regulatory properties. High numbers of Foxp3 regulatory T cells and gamma-delta T cells have been reported in patients with LCH, although, the cause of their presence or their significance is not ye...
Cardiovascular diseases (CVD) account for nearly half of all deaths in Europe and almost 30% of global deaths. Despite the improved clinical management, cardiovascular mortality is predicted to rise in the next decades due to the increasing impact of aging, obesity and diabetes. The goal of emerging cardiovascular nanomedicine is to reduce the burden of CVD using nanoscale medical products and devices. However, the development of novel multicomponent nano-sized products poses multiple technical, ethical and...
To investigate an outbreak of invasive meningococcal disease (IMD) in Southern Sardinia.
Initial clinical trials of adoptive regulatory T-cell (Treg) therapy in solid organ transplantation have proven to be both feasible and well tolerated. With Phase 2 trials underway, efforts have been focused on the optimization of the Treg product.
"Thorough QT/QTc" (TQT) studies are cornerstones of clinical cardiovascular safety assessment. However, TQT studies are resource intensive, and preclinical models predictive of the threshold of regulatory concern are lacking. We hypothesized that an in vitro model using iPSC-derived cardiomyocytes from a diverse sample of human subjects can serve as a "TQT study in a dish." For 10 positive and 3 negative control drugs, in vitro concentration-QTc, computed using a population Bayesian model, accurately predic...
Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective ris...
Direct observation of medical students' history and physical examination (H&P) skills by attendings is essential in ensuring trainees' competence. This study compared whether partial observations by multiple pediatric attendings across various clinical encounters versus a full observation by one attending affected students' performance on the pediatric Objective Structured Clinical Examination (OSCE) and the Year 3 Clinical Performance Examination (CPX3).
Advances in genetic sequencing and other diagnostic technologies have enabled the use of precision medicine in clinical cancer care, as well as the development of novel therapies that are targeted to specific molecular drivers of cancer. Developing these new agents and making them accessible to patients requires global clinical studies and regulatory review and approval by different national regulatory agencies. Whereas these global trials present challenges for drug developers who conduct them and regulato...