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20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic.

•In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator.•The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.•It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.•Recent reforms to the Scheme contribute to, and anticipate, the con

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… The OGTR accreditation and facility certification systems have ensured clinical applications are sponsored by suitable organizations and conducted in appropriate containment facilities. Clinical trials are overseen by IBCs with appropriate expertise to assess safety of the gene modified products. …

National burden of cancer in Italy, 1990-2017: a systematic analysis for the global burden of disease study 2017.

We monitored the burden of cancer in Italy and its trends over the last three decades, providing estimates of cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years (DALYs), for cancer overall and 30 cancer sites using data from the Global Burden of Disease study 2017. An overview of mortality trends between 1990 and 2017 was also provided. In 2017, there were 254,336 new cancer cases in men and 214,994 in women, corresponding to an age-standardized incidence rate (ASIR) of 438 and 330/100,000, respectively. Between 1990 and 2017, incid

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… In Italy, vital registration data are available since long time, has a 99% coverage, and cancer certification is reasonably reliable and valid, particularly for most common neoplasms 7 . Italian cancer registries cover approximatively 70% of the Italian population 46 . …

Mass Spectrometry Approaches for Identification and Quantitation of Therapeutic Monoclonal Antibodies in the Clinical Laboratory.

Therapeutic monoclonal antibodies (MAbs) are an important class of drugs used to treat diseases ranging from autoimmune disorders to B cell lymphomas to other rare conditions thought to be untreatable in the past. Many advances have been made in the characterization of immunoglobulins as a result of pharmaceutical companies investing in technologies that allow them to better understand MAbs during the development phase. Mass spectrometry is one of the new advancements utilized extensively by pharma to analyze MAbs and is now beginning to be applied in the clinical laboratory setting. The rise

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… Beyond the certification of the performance of a method, there should also be predetermined decision points at each step on whether acceptance criteria have been met for that particular step and whether it is feasible to move on to the next step. …

The assessment, serial evaluation, and subsequent sequelae of acute kidney injury (ASSESS-AKI) study: design and methods.

BACKGROUND: The incidence of acute kidney injury (AKI) has been increasing over time and is associated with a high risk of short-term death. Previous studies on hospital-acquired AKI have important methodological limitations, especially their retrospective study designs and limited ability to control for potential confounding factors. METHODS: The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study was established to examine how a hospitalized episode of AKI independently affects the risk of chronic kidney disease development and progression, cardi

Deployed national healthcare services in Hajj mass gathering settings: emergency department experience of Makkah Diyanet Hospital during the 2025 Hajj period.

BackgroundClinical and operational data from independent national Hajj health missions are extremely limited. This study aimed to analyze the demographic and clinical characteristics, presentation patterns, and clinical outcomes of patients presenting to the emergency department of the Makkah Diyanet Turkey Hospital during the 2025 Hajj season.MethodsA retrospective, cross-sectional, analytical study was conducted at a hospital serving 84,942 Turkish pilgrims between April and July 2025. Diagnoses were coded using the International Classification of Diseases, 10th Revision (ICD-10). Referral,

Maximizing the impact of real-world evidence on cancer treatment: what do we need to achieve it?

There is an increasing number of studies using real-world data to examine outcomes of drugs in clinical practice. Therefore, it is crucial to carefully evaluate their quality and findings, extract valuable insights, acknowledge their limitations and identify gaps to advance further their use in decision-making. Here we provide an overview of the opportunities offered throughout drug lifecycle, and challenges presented by real-world evidence (RWE) studies. We also highlight the importance of the culture of transparency, along with the development of good practices for reporting RWE studies. In

Exploring the mechanism of rosmarinic acid in the treatment of lung adenocarcinoma based on bioinformatics methods and experimental validation.

ObjectiveRosmarinic acid (RosA) is a natural polyphenol compound that has been shown to be effective in the treatment of inflammatory disease and a variety of malignant tumors. However, its specific mechanism for the treatment of lung adenocarcinoma (LUAD) has not been fully elucidated. Therefore, this study aims to clarify the mechanism of RosA in the treatment of LUAD by integrating bioinformatics, network pharmacology and in vivo experiments, and to explore the potential of the active ingredients of traditional Chinese medicine in treating LUAD.MethodsFirstly, the network pharmacology was u

Artificial Intelligence in the Management of Hereditary and Acquired Hemophilia: From Genomics to Treatment Optimization.

Hemophilia, an X-linked bleeding disorder, is characterized by a deficiency in coagulation factors. It manifests as spontaneous bleeding, leading to severe complications if not properly managed. In contrast, acquired hemophilia is an autoimmune condition marked by the development of inhibitory antibodies against coagulation factors. Both forms present significant diagnostic and therapeutic challenges, highlighting the need for advanced genetic, molecular, laboratory, and clinical assessments. Recent advances in artificial intelligence have opened new avenues for the management of hemophilia. M

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… For widespread clinical adoption, large-scale studies, regulatory certifications as medical devices, and broader implementation across healthcare settings will be necessary elements that were notably absent from the reviewed literature. …

Transcriptomic profiling identifies ferroptosis and NF-κB signaling involved in α-dimorphecolic acid regulation of microglial inflammation.

BACKGROUND: Microglia-evoked neuroinflammation contributes to neurodegenerative diseases such as multiple sclerosis (MS). Metabolic reprogramming, including changes in polyunsaturated fatty acids (PUFAs), plays a critical role in MS pathophysiology. Previous studies identified reduced plasma α-dimorphecolic acid (α-DIPA), a linoleic acid derivative, in MS patients. This study investigated the anti-inflammatory effects of α-DIPA on microglia and the underlying pathways. METHODS: Lipopolysaccharide (LPS)-induced BV-2 microglial inflammation was used as an in vitro model. α-DIPA effects were ass

Catgut embedding in acupoints combined with repetitive transcranial magnetic stimulation for the treatment of postmenopausal osteoporosis: study protocol for a randomized clinical trial.

BACKGROUND: To date, the clinical modulation for bone metabolism based on the neuro-bone mass regulation theory is still not popular. The stimulation of nerve systems to explore novel treatments for Postmenopausal osteoporosis (PMOP) is urgent and significant. Preliminary research results suggested that changes brain function and structure may play a crucial role in bone metabolism with PMOP. Thus, we set up a clinical trial to investigate the effect of the combination of repetitive transcranial magnetic stimulation (rTMS) and catgut embedding in acupoints (CEA) for PMOP and to elucidate the c

Opioid Use at End-Of-Life Among Nova Scotia Patients With Cancer.

Purpose: To determine the factors associated with opioid analgesic prescriptions as measured by community pharmacy dispensations to all Nova Scotia (NS) patients with cancer at end-of-life from 2005 to 2009. Methods: The NS Cancer Registry and the NS Prescription Monitoring Program (NSPMP) were used to link Nova Scotians who had a cancer diagnosis and received a prescription for opioids in their last year of life (n = 6,186) from 2005 to 2009. The association of factors with opioid dispensations at end-of-life were determined (e.g., patient demographics, type of prescriber, type of cancer, and

Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life Years for 29 Cancer Groups From 2010 to 2019: A Systematic Analysis for the Global Burden of Disease Study 2019.

IMPORTANCE: The Global Burden of Diseases, Injuries, and Risk Factors Study 2019 (GBD 2019) provided systematic estimates of incidence, morbidity, and mortality to inform local and international efforts toward reducing cancer burden. OBJECTIVE: To estimate cancer burden and trends globally for 204 countries and territories and by Sociodemographic Index (SDI) quintiles from 2010 to 2019. EVIDENCE REVIEW: The GBD 2019 estimation methods were used to describe cancer incidence, mortality, years lived with disability, years of life lost, and disability-adjusted life years (DALYs) in 2019 and over

Mid-arm muscle circumference as a substantial factor against mortality among people with elevated gamma gaps.

Gamma gap is the difference in total serum proteins and albumin and an elevated gamma gap is related to infections, malignancy, and rheumatic diseases. An elevated gamma gap is also associated with higher mortality due to the correlation with inflammatory status. The study aimed to utilize mid-arm muscle circumference (MAMC) to assist in predicting all-cause mortality, cancer mortality, and cardiovascular mortality in people with elevated gamma gaps. Data were obtained from the third U.S. National Health and Nutrition Examination Survey (1988-1994), which contained 14,011 adults aged 20 to 90

The Production Processes and Biological Effects of Intravenous Immunoglobulin.

Immunoglobulin is a highly diverse autologous molecule able to influence immunity in different physiological and diseased situations. Its effect may be visible both in terms of development and function of B and T lymphocytes. Polyclonal immunoglobulin may be used as therapy in many diseases in different circumstances such as primary and secondary hypogammaglobulinemia, recurrent infections, polyneuropathies, cancer, after allogeneic transplantation in the presence of infections and/or GVHD. However, recent studies have broadened the possible uses of polyclonal immunoglobulin showing that it ca

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… European Medicines Agency Guideline on the Requirements for Plasma Master File (PMF) Certification Available online: http://ec.europa.eu/health/files/eudralex/vol-2/c/466303en_08_2004_en.pdf (accessed on 22 August 2014) 24. Martin T.D. …

Second-Class Care: How Immigration Law Transforms Clinical Practice in the Safety Net.

This article examines how U.S. immigration law extends into the health care safety net, enacting medical legal violence that diminishes noncitizens' health chances and transforms clinical practices. Drawing on interviews with health care workers in three U.S. states from 2015 to 2020, I ask how federal citizenship-based exclusions within an already stratified health care system shape the clinical trajectories of noncitizens in safety-net institutions. Focusing specifically on cancer care, I find that increasingly anti-immigrant federal policies often reshape clinical practices toward noncitize

Doxorubicin-induced neurotoxicity differently affects the hippocampal formation subregions in adult mice.

Doxorubicin (DOX) is an anthracycline used to treat a wide range of tumours. Despite its effectiveness, it is associated with a long range of adverse effects, of which cognitive deficits stand out. The present study aimed to assess the neurologic adverse outcome pathways of two clinically relevant cumulative doses of DOX. Adult male CD-1 mice received biweekly intraperitoneal administrations for 3 weeks until reaching cumulative doses of 9 mg/kg (DOX9) or 18 mg/kg (DOX18). Animals were euthanized one week after the last administration, and biomarkers of oxidative stress and brain metabolism we

Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial.

BackgroundImproving the health of chronically ill older adults is a major challenge facing modern health care systems. A community-based nursing intervention developed by Health Quality Partners (HQP) was one of 15 different models of care coordination tested in randomized controlled trials within the Medicare Coordinated Care Demonstration (MCCD), a national US study. Evaluation of the HQP program began in 2002. The study reported here was designed to evaluate the survival impact of the HQP program versus usual care up to five years post-enrollment.Methods and findingsHQP enrolled 1,736 adult

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… The program was designed and promoted as easy to use and free of burdens related to: paperwork, recurring authorizations or pre-certifications, routine case reviews, or administrative tasks. …

Temporal Trends in Cancer Burden and 27 Subtypes Among Women of Childbearing Age Globally from 1990 to 2021.

BackgroundCancer among women of childbearing age (WCBA, 15-49 years) has distinct clinical and public health implications. Using modeled estimates from the Global Burden of Disease Study (GBD) 2021, we assessed temporal and spatial patterns of total cancer and 27 cancer subtypes among WCBA from 1990 to 2021.MethodsWe extracted incidence and mortality estimates for WCBA globally, across five socio-demographic index (SDI) regions, 21 GBD regions, and 204 countries and territories. Age-standardized incidence rates (ASIRs) and age-standardized mortality rates (ASMRs) were calculated. Temporal tren

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… In particular, limited diagnostic capacity, incomplete population-based cancer registries, and insufficient cause-of-death certification in several low- and middle-income countries may lead to underdiagnosis and underreporting of cancer incidence and mortality. …

Integration of geriatric assessment-guided care plan modifications and interventions into clinical paths of older adults with cancer (GORILLA): a feasibility approach.

PurposeA comprehensive geriatric assessment (CGA) followed by geriatric assessment-guided interventions was demonstrated to reduce treatment-related toxicities CTCAE III°-V° in older adults with cancer undergoing systemic cancer treatments, but implementation remains insufficient. Thus, we aimed to evaluate the feasibility of implementing CGA into routine care and multidisciplinary tumor boards (MDTs) in Germany within a bicentric feasibility trial (DRKS00035569; 19.12.2024).MethodsPatients ≥ 65 years with positive geriatric screening (G8 Results75 patients received CGA (62.5% females). Of tho

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… In addition, geriatric screening is increasingly being mandated for the certification of German cancer centers. If this will translate to a higher demand for subsequent geriatric consultations remains to be seen. …

Navigating Hope and Illness Cognition in Advanced Ovarian Cancer Patients: A CSM-Based Phenomenological Study.

BACKGROUND: Advanced ovarian cancer patients face profound psychosocial challenges in maintaining hope amidst terminal illness and treatment uncertainty. Understanding mechanisms supporting adaptive hope could inform psychosocial interventions. METHODS: Phenomenological qualitative study of 16 women with advanced ovarian cancer receiving platinum-based and/or targeted therapies at a tertiary center in southern China. Semi-structured interviews conducted across 11-month observation period; thematic analysis guided by Leventhal's Common-Sense Model (CSM). RESULTS: Participants demonstrated a t

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… All researchers completed CITI certification in qualitative research ethics. Interview transcripts were de‐identified using pseudonymization protocols compliant with GDPR standards. …