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Profile and Management of Toxicity of Selinexor and Belantamab Mafodotin for the Treatment of Triple Class Refractory Multiple Myeloma.

Treatment options are limited for multiple myeloma patients who have developed four/five drug-refractory disease. Selinexor (Sel) and belantamab mafodotin (belamaf) were recently approved by the US FDA for treatment of RRMM. The toxicity profile of these drugs is a concern since these agents are used in patients who have already undergone multiple lines of treatment. In this review, we discuss the toxicity profile and strategies for the management of toxicities of Sel and belamaf for the treatment of RRMM. We conducted a comprehensive literature search on PubMed, Embase, Cochrane, and Clinical

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… Belamaf is currently available under REMS program that requires special certification for prescribers. …

Poster Abstracts

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Материалы ежегодной конференции Канадского общества респираторных терапевтов, май 8-10, 2025.

Мы рады представить ряд выдержек из работы ежегодной Конференции по ТРСК. состоявшемся в Оттаве, Онтарио, в мае 8 в адрес 10, 2025, эта конференция включала в себя темы, подготовленные отдельными лицами, имеющими опыт работы в различных областях практики дыхательной терапии. Как видно из следующих резюме, работа наших коллег 2025 :: акцентировали внимание на текущих исследовательских и практических нововведениях, осуществляемых РТ. Мы приложили все усилия для того, чтобы включить все выдержки, принятые Комитетом по программе до предельного срока публикации; вместе с тем просьба иметь в виду, ч

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… Purpose: To develop a respiratory services index tool that objectively measures respiratory services that can account for the unique practices, certifications, and clinical workload that accurately reflects the balance between staffing and clinical need. …

Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023.

An increase in total drug (small molecules and biologics) approvals by the Food and Drug Administration (FDA) was seen in 2023 compared with the previous year. Cancer remained the disease most targeted by monoclonal antibodies (mAbs), followed by autoimmune conditions. Our data reveal the prevalence of approvals for biologics even during years when the total number of authorizations was low, such as in 2022. Over half the drugs that received the green light in 2023 benefited from expedited programs, as the incidence of many diseases increased. In addition, over half of the biologics approved r

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… In addition, the FDA requires compliance from both the investigator and the sponsor of a study, whereas the HHS requires assurances and certifications from institutions. …

Interactions between kidney disease and diabetes: dangerous liaisons.

BackgroundType 2 diabetes mellitus (DM) globally affects 18-20 % of adults over the age of 65 years. Diabetic kidney disease (DKD) is one of the most frequent and dangerous complications of DM2, affecting about one-third of the patients with DM2. In addition to the pancreas, adipocytes, liver, and intestines, the kidneys also play an important role in glycemic control, particularly due to renal contribution to gluconeogenesis and tubular reabsorption of glucose.MethodsIn this review article, based on a report of discussions from an interdisciplinary group of experts in the areas of endocrinolo

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… A list of methods and worldwide laboratories, the certification of which depends on the demonstration of an acceptable accuracy and compliance with DCCT standards, is also provided on their website ( http://www.ngsp.org ) [ 41 ]. …

Implementing patient-centred outcome measures in palliative care clinical practice. An updated systematic review of facilitators and barriers.

BackgroundPatient-centred outcome measures (PCOMs), when well implemented, are powerful tools facilitating patient, family and clinical communication to better respond to patient needs. Their routine use in palliative care practice still faces challenges.ObjectiveTo update a systematic review of PCOMs implementation, reviewing and synthesising new evidence on facilitators, barriers, lessons learned, measures used, models of implementation, costs, implementation outcomes, and consequences in clinical practice.MethodsWe searched eight information sources supplemented by hand-searching and citati

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… potentially reducing the cost and effort of that management - Collected items are reviewed with the aim of being clinically relevant and not burdensome to collect - PCOMs reflect the excellence of the health service delivered and to use them in a continuous base for quality improvement and programme certification …

Alternative Cancer Therapeutics: Unpatentable Compounds and Their Potential in Oncology.

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to hi

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… This involves a certification of potential benefits at the patent application stage, followed by empirical verification, to maintain patent validity. Enhancing postmarketing surveillance and mandating Phase 4 clinical trials would further ensure real-world efficacy and cost-effectiveness. …

Geriatric assessment for the practicing clinician: The why, what, and how.

Older adults with cancer heterogeneously experience health care, treatment, and symptoms. Geriatric assessment (GA) offers a comprehensive evaluation of an older individual's health status and can predict cancer-related outcomes in individuals with solid tumors and those with hematologic malignancies. In the last decade, randomized controlled trials have demonstrated the benefits of GA and GA management (GAM), which uses GA information to provide tailored intervention strategies to address GA impairments (e.g., implementing physical therapy for impaired physical function). Multiple phase 3 cli

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… Sci Data . 2016 ; 3 ( 1 ): 160018 . doi: 10.1038/sdata.2016.18 PMC4792175 26978244 141. 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. 85 Federal Register 25642 – 25961 . 2020 . 142. …

The burden of disease in Spain: results from the global burden of disease study 2010.

BackgroundWe herein evaluate the Spanish population's trends in health burden by comparing results of two Global Burden of Diseases, Injuries, and Risk Factors Studies (the GBD studies) performed 20 years apart.MethodsData is part of the GBD study for 1990 and 2010. We present results for mortality, years of life lost (YLLs), years lived with disability, and disability-adjusted life years (DALYs) for the Spanish population. Uncertainty intervals for all measures have been estimated.ResultsNon-communicable diseases accounted for 3,703,400 (95% CI 3,648,270-3,766,720) (91.3%) of 4,057,400 total

СРП 2013

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… Kaste, DO SPR 2013 Organization Continuing Medical Education Maintenance of Certification Objectives Disclosure Acknowledgements Program Schedule Scientific Exhibits/Posters General Information Mission Statement Sites of Previous Meetings Future Meetings Officers, Directors and Committees … fulfilling requirements in the ABR Maintenance of Certification Program. …

The Past, Present, and Future of Clinically Applied Chimeric Antigen Receptor-T-Cell Therapy.

Immunotherapy represents the fourth pillar of cancer therapy after surgery, chemotherapy, and radiation. Chimeric antigen receptor (CAR)-T-cell therapy is an artificial immune cell therapy applied in clinical practice and is currently indicated for hematological malignancies, with cluster of differentiation 19 (CD19) as its target molecule. In this review, we discuss the past, present, and future of CAR-T-cell therapy. First, we summarize the various clinical trials that were conducted before the clinical application of CD19-targeted CAR-T-cell therapies began. Second, we discuss the accumulat

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… As there are standards and certifications for cell therapy put forth by regulatory bodies, such as the Foundation for the Accreditation of Cellular Therapy (FACT) in the US and FACT-JACIE (The Joint Accreditation Committee ISCT-Europe & EBMT) in the EU, it is necessary to prepare a hospital in terms …

Systemic Sclerosis Association with Malignancy.

The association of systemic sclerosis (SSc) and cancer is well known from several decades suggesting common genetic and environmental risk factors involved in the development of both diseases. Immunosuppressive drugs widely used in SSc may increase the risk of cancer occurrence and different SSc clinical and serological features identify patients at major risk to develop malignancy. In this context, among serological features, presence of anti-RNA polymerase III and anti-topoisomerase I autoantibodies seems to increase cancer frequency in SSc patients (particularly lung and breast cancers). Lu

Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.

Cell and gene therapies (CGTs) have progressed from proof of concept to an established commercial pipeline, yet global translation remains constrained by fragmented regulatory frameworks; heterogeneous Chemistry, Manufacturing, and Controls (CMC) requirements; and divergent approval pathways. This narrative review compares CGT quality, CMC, and approval-pathway regulation across the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), together with five emerging-market agencies: Brazil, Russia, India, China, and

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… Manufacturing capacity for CGTs is concentrated in a small number of academic research institutes and state biomedical enterprises operating under EAEU GMP certification; specialized inspection expertise for viral vector production and complex cell-manipulation environments is an area of continuing development …

Regenerative rehabilitation: a novel multidisciplinary field to maximize patient outcomes.

Regenerative rehabilitation is a novel and rapidly developing multidisciplinary field that converges regenerative medicine and rehabilitation science, aiming to maximize the functions of disabled patients and their independence. While regenerative medicine provides state-of-the-art technologies that shed light on difficult-to-treated diseases, regenerative rehabilitation offers rehabilitation interventions to improve the positive effects of regenerative medicine. However, regenerative scientists and rehabilitation professionals focus on their aspects without enough exposure to advances in each

Early detection of sporadic pancreatic cancer: summative review.

Pancreatic cancer (PC) is estimated to become the second leading cause of cancer death in the United States by 2020. Early detection is the key to improving survival in PC. Addressing this urgent need, the Kenner Family Research Fund conducted the inaugural Early Detection of Sporadic Pancreatic Cancer Summit Conference in 2014 in conjunction with the 45th Anniversary Meeting of the American Pancreatic Association and Japan Pancreas Society. This seminal convening of international representatives from science, practice, and clinical research was designed to facilitate challenging interdiscipli

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… At this time, positive selection capture techniques have the most data supporting their clinical use, and some versions of these devices have gone on to validation studies in clinical trials and CLIA (Clinical Laboratory Improvement Amendments) certification. …

The Danish health care system and epidemiological research: from health care contacts to database records.

Denmark has a large network of population-based medical databases, which routinely collect high-quality data as a by-product of health care provision. The Danish medical databases include administrative, health, and clinical quality databases. Understanding the full research potential of these data sources requires insight into the underlying health care system. This review describes key elements of the Danish health care system from planning and delivery to record generation. First, it presents the history of the health care system, its overall organization and financing. Second, it details d

Отчет о ДИД 1st Ежегодный Всемирный конгресс биомедицинской инженерии, проводимый в Сиане, Китай, 9-11 ноябрь 2017.

Мы рады представить на этом заседании резюме доклада "ДИД" 1st Всемирный конгресс биомедицинской инженерии 2017которая была проведена в Сиане в Китае [...].

37th International Symposium on Intensive Care and Emergency Medicine (part 2 of 3) : Brussels, Belgium. 21-24 March 2017

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Network approach in liquidomics landscape.

Tissue-based biopsy is the present main tool to explore the molecular landscape of cancer, but it also has many limits to be frequently executed, being too invasive with the risk of side effects. These limits and the ability of cancer to constantly evolve its genomic profile, have recently led to the need of a less invasive and more accurate alternative, such as liquid biopsy. By searching Circulating Tumor Cells and residues of their nucleic acids or other tumor products in body fluids, especially in blood, but also in urine, stools and saliva, liquid biopsy is becoming the future of clinical

Эпигенетическая ось Лактата-H4K12la-HDAC1 регулирует переход к микроглиальному состоянию во время экспериментального аутоиммунного энцефаломиелита у женских мышей.

Микроглиальная функциональная пластичность формируется метаболическим и эпигенетическим перепрограммированием, но то, как эти процессы регулируют автоиммунитет центральной нервной системы, остается неясным. Мы находим, что уровень цереброспинарной жидкости лактат коррелирует с множественным склерозом. Используя женские модели мыши экспериментального аутоиммунного энцефаломиэлита, аккумуляция спинного лакта приводит к стойкой микроглиальной гистоне лактилации, связывающей с гликолитической активацией. Микроглиавое исключение лактата дегидрогеназы А уменьшает эту лактиляцию и усугубляет остроту