Background: Rapid digital transformation is reshaping health care, but many digital initiatives struggle to deliver sustained organizational value when they are introduced as stand-alone technologies rather than as part of an institutional strategy. In Saudi Arabia, Vision 2030 has intensified pressure on academic medical centers to strengthen digital capability, localize innovation, and reduce dependence on externally driven solutions. Objective: This study aimed to examine organizational factors shaping digital health innovation at King Saud University Medical City (KSUMC) and to develop a preliminary strategic planning framework for a digital health innovation hub tailored to that setting. Methods: We conducted a qualitative exploratory case study at KSUMC between April and June 2025. Fourteen stakeholders from clinical, administrative, research, governance, educational, and innovation-related roles were recruited using maximum variation purposive sampling. Semistructured interviews were audio-recorded, transcribed verbatim, and analyzed using reflexive thematic analysis. Reporting was guided by the COREQ (Consolidated Criteria for Reporting Qualitative Research). Diffusion of innovation theory and systems thinking informed interpretation, while a context-actor-mechanism-outcome lens was used to examine how institutional conditions shaped innovation processes. No patient data were collected. Results: Five interrelated themes were identified. First, leadership support existed at a symbolic level, but middle-management translation and risk tolerance were inconsistent. Second, innovation was constrained by workload, fragmented systems, and weak operational support, which meant that project work was often treated as discretionary rather than embedded. Third, knowledge transfer and commercialization pathways were fragmented; participants repeatedly described unclear routes from idea generation to prototyping, regulatory review, and market engagement. Fourth, incentives and innovation capability were misaligned with institutional expectations, particularly for clinicians and trainees. Fifth, Vision 2030 created strategic legitimacy and momentum, but participants also cautioned that an overreliance on consultant-led or vendor-led approaches could weaken internal capability building. These findings informed a preliminary framework centered on governance, knowledge transfer, partnership structures, workforce development, and phased implementation rather than a validated institutional model. Conclusions: At KSUMC, digital health innovation is shaped not only by technology availability but also by organizational culture, intermediary structures, governance design, and the extent to which innovation work is made operationally feasible. The framework proposed here should therefore be understood as a preliminary planning model derived from one qualitative case study. Its main contribution is to specify how knowledge transfer, commercialization, and institutional capability building can be integrated into a digital health strategy within a Saudi academic medical center.
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FDA authorized Zyn nicotine pouches without knowing what they were made of, says former agency scientist
Four years into the U.S. Food and Drug Administration’s review of Zyn nicotine pouches, and not long before the agency approved them for sale, an FDA toxicologist ran some informal tests in her kitchen that led her to question whether the agency truly understood the addictive product it was about to green-light.
Christy Leppanen worked for the FDA’s Center for Tobacco Products, where she led a project examining the potential for microplastics exposure. A scientist who had worked on an environmental assessment of Zyn had repeatedly told her that the nicotine pouches melt in the mouth. But during a public health conference in late 2024, Leppanen said, she talked to an academic who reinforced her understanding that they don’t.
Prevalence and predictors of HCV infection among hospitalized psychiatric patients in Poland
BackgroundPatients with mental disorders are at increased risk of hepatitis C virus (HCV) infection, yet the prevalence of HCV among patients in Polish psychiatric ward remains unknown.MethodsA cross-sectional survey was conducted in Poland from 2021 to 2023 in psychiatric wards. Adults recently hospitalized with at least one current mental health condition were eligible and 12–897 individuals were tested for anti HCV antibodies. Patients with confirmed active HCV infection (subsequent nucleic acid testing) were offered treatment.ResultsOf the 12,897 individuals who constituted the sample, 64% were male, and the median age was 45 years (interquartile range: 35–58 years). Among those subjects, 226 patients (representing 1.8% of the total) exhibited a positive HCV antibody test result, and 172 of these patients had active HCV infection (the prevalence of 1.3%). Multivariate analysis identified five risk factors for HCV infection within the investigated population: intravenous drug use (odds ratio [OR] = 9.40; 95% confidence interval [CI]: 6.12–14.44; p<0.001), diagnosed and treated liver disease (OR = 6.17; 95% CI: 4.10–9.26; p < 0.001); blood transfusions prior to 1992 (OR = 2.61; 95% CI: 1.29–5.28; p=0.008), diagnosis of mental and behavioral disorders due to psychoactive substance abuse (OR = 1.97; 95% CI: 1.34–2.91; p=0.001) and previous incarceration (OR = 1.62; 95% CI: 1.08–2.43, p=0.018).ConclusionsHigh prevalence of HCV infection in patients with mental health disorders and specifically in patients who used intravenous drugs suggests the importance of screening for HCV in this vulnerable population.
Brain Scans Reveal Dopamine Damage in Long COVID, Pointing to New Treatments
New brain imaging research has provided the strongest evidence to date that long COVID is associated with injury to the brain’s dopamine system, offering a potential biological explanation for persistent symptoms such as fatigue, slowed movement, lack of motivation, and memory problems.
The study, published in eBioMedicine by researchers at the Centre for Addiction and Mental Health in Canada, used positron emission tomography (PET) imaging to examine dopamine-releasing neurons in people with long COVID. The findings suggest that reduced dopamine nerve terminal density in key brain regions may underlie many of the neurological symptoms experienced by patients and identify a potential therapeutic target for future treatments.
Long COVID is estimated to affect approximately nine million adults in the United States and about 5% of the global population, making it one of the most common chronic conditions to emerge from the COVID-19 pandemic. The condition is characterized by symptoms that persist for at least three months after the initial SARS-CoV-2 infection and commonly includes fatigue, brain fog, memory impairment, and mood changes. Despite its prevalence, there are currently no evidence-based treatments, largely because the biological mechanisms driving these symptoms remain poorly understood.
To investigate whether the brain’s dopamine system is involved, the researchers used PET imaging to measure a well-established marker of dopamine neuron integrity in individuals with long COVID and healthy control participants.
Compared with healthy volunteers, participants with long COVID had significantly lower levels of the dopamine neuron marker throughout the striatum, a brain region that plays a central role in motivation, movement, learning, and cognition. The reduced signal indicates a loss of dopamine nerve terminal density, providing direct evidence that dopamine-releasing neurons are injured in long COVID.
The imaging findings also closely matched patients’ clinical symptoms. Lower dopamine markers in the ventral striatum were associated with greater loss of motivation, reductions in the dorsal putamen correlated with slower movement, and lower marker levels in the caudate were linked to poorer memory performance. The pattern suggests that damage within specific regions of the dopamine system may contribute to distinct neurological symptoms experienced by people with long COVID.
The findings build on the research group’s earlier work demonstrating elevated inflammation in the brains of people with long COVID, particularly in regions rich in dopamine-producing neurons. Because inflammation is known to damage dopamine neurons in other neurological disorders, the new study provides direct evidence that this inflammatory process may be accompanied by measurable injury to the brain’s dopamine system. The close relationship between dopamine neuron loss and symptom severity further strengthens the case that dopamine dysfunction plays a central role in the condition.
The study also shifts attention beyond inflammation alone and suggests that long COVID should be considered, at least in part, a disorder affecting the brain’s dopamine system. That conclusion has important therapeutic implications because several medications already approved for other neurological disorders increase dopamine availability or enhance dopamine signaling. The researchers suggest that repurposing dopamine precursors or drugs that inhibit dopamine metabolism could represent a promising strategy for treating persistent cognitive and neurological symptoms associated with long COVID.
The findings also provide biological evidence supporting the experiences of people living with long COVID, many of whom have struggled for years with debilitating symptoms despite the absence of clear diagnostic markers. By demonstrating measurable injury to dopamine-releasing neurons, the study offers objective evidence that persistent neurological symptoms have a biological basis.
Building on these results, the investigators plan to launch a clinical trial in collaboration with University Health Network to evaluate whether therapies that improve dopamine function can reduce fatigue, improve motivation, and enhance memory in people with long COVID. If successful, the trial could pave the way for one of the first mechanism-based treatment approaches for the condition.
The post Brain Scans Reveal Dopamine Damage in Long COVID, Pointing to New Treatments appeared first on Inside Precision Medicine.
Treating addiction with an addictive drug: the ketamine paradox revisited
BackgroundSubstance use disorders (SUDs) and treatment-resistant depression (TRD) remain a major global health challenge, marked by high relapse rates and limited long-term effectiveness of existing treatments. Ketamine, a glutamatergic modulator with rapid neuroplastic effects, has emerged as a novel intervention for TRD and is increasingly investigated as an adjunctive treatment for addiction, yet concerns about its abuse liability persist.ObjectiveThis review critically evaluates ketamine’s therapeutic potential for SUDs while examining its neurobiological mechanisms, clinical efficacy, and risk of misuse within a unified risk–benefit framework.MethodsA structured narrative review conducted in accordance with the SANRA framework using the PubMed, Scopus, PsycINFO, and Web of Science databases, covering literature published until March 2026. Eligible studies included clinical trials, experimental studies, and mechanistic investigations relevant to ketamine use in addiction and depression. Evidence was synthesized thematically across the domains of efficacy, mechanisms, and safety.ResultsAcross alcohol and cocaine use disorders, ketamine combined with psychotherapy has demonstrated promising reductions in craving and increases in abstinent days in small-to moderate-sized Phase 2 trials. However, findings remain difficult to generalize due to considerable variability in dosing strategies, comparator conditions, and follow-up periods. Effects on relapse prevention have been more inconsistent and less reliably positive. Mechanistically, ketamine promotes synaptic plasticity via NMDA receptor antagonism and downstream glutamatergic signaling, potentially disrupting maladaptive reward-related memories and reversing maladaptive neurocircuitry involved in both depression and addiction. While acute adverse effects are generally transient under clinical supervision, ketamine carries a well-established risk of misuse, particularly in unsupervised or high-dose settings.ConclusionsKetamine represents a promising but still experimental intervention for both refractory depression and selected SUDs. Its clinical use depends on careful patient selection, structured delivery, and integration with psychotherapy. Although ketamine may redefine treatment paradigms for TRD and addiction, larger-scale trials and long-term safety data are essential to define its role within psychiatric and addiction treatment frameworks.
The Effect of Comorbid Alcohol/Substance Use
Conditions: Alcohol Abuse; Alcohol Use Disorder; Substance Use Disorders; Severe Mental Disorder; Schizophrenia; Bipolar Disorder; Ostracism
Interventions: Other: scale
Sponsors: Abant Izzet Baysal University
Recruiting
Interventions: Other: scale
Sponsors: Abant Izzet Baysal University
Recruiting
Identifying Biomarkers Related to Opioid Use and Pain Response Following Traumatic Injury and Surgery
Conditions: Opioid Use Disorder; Opioid Consumption; Persistent Opioid Use; Persistent Postsurgical Pain
Sponsors: University of California, San Diego
Not yet recruiting
Sponsors: University of California, San Diego
Not yet recruiting
Implementing DBT in Short-Term SUD-treatment
Conditions: Substance Abuse Disorder; Dialectical Behavior Therapy; Emotion Management Skills
Interventions: Behavioral: DBT-informed milieu therapy; Behavioral: Treatment as usual
Sponsors: Helse Møre og Romsdal HF
Not yet recruiting
Interventions: Behavioral: DBT-informed milieu therapy; Behavioral: Treatment as usual
Sponsors: Helse Møre og Romsdal HF
Not yet recruiting
Plant Expression Platforms May Be Better Option for Biopharma in the Global South
Mammalian cell-based manufacturing systems cannot meet the needs of the Global South, say researchers, who suggest that local production with plant-based expression platforms is a potential low-cost alternative. The researchers made their case in a recent paper, arguing that although mammalian systems are a good option for countries where centralized production facilities can be established, they are less suited to resource-limited regions.
“Mammalian cell lines, particularly Chinese hamster ovary cells, are the industry standard for producing complex biologics that require human-like PTMs [post-translational modifications], offering high-quality mAbs and vaccines with established regulatory approvals for pandemic applications.
“However, their high operational costs, slow doubling times, susceptibility to viral contamination, and dependence on expensive media significantly limit global equity and accessibility, particularly in resource-constrained settings such as the Global South,” the authors write.
Plant-based expression
Overcoming these constraints and increasing access to medicines in the Global South, will require the establishment of local production capacity that is both economically and environmentally sustainable, the authors say, citing plant-based systems as a potential option.
“Plants are increasingly used as platforms for producing vital biological molecules, such as pharmaceuticals and industrial biomaterials, through advanced strategies, including genetic engineering, process automation, and precision agriculture.”
The authors point to things like the Gaucher’s disease drug, Elelyso, the Ebola treatment, ZMapp, and the COVID-19 vaccine, Covifenz, as examples of current plant-made biopharmaceutical products.
And the potential advantages are significant. For one thing, plant-based systems are generally faster to produce protein and more easily scalable than mammalian platforms, according to the authors.
“Plant-based expression systems, particularly seed-based platforms such as rice, wheat, tobacco, sorghum, etc., offer scalable, field-level production regarded as safe status, low-cost PTMs, and exceptional environmental advantages.
“These systems enable decentralized, long-term stable storage of biologics and the production of animal-free, glycosylated therapeutics, significantly enhancing health security in resource-limited settings,” they write.
And the utility of plant-based expression systems is being further enhanced by new genetic modification techniques. The authors cite AI-driven genomic optimization and glyco-engineering as examples of how such systems are being improved.
“Drought-tolerant plant platforms can significantly enhance local production capacity in developing economies, addressing critical barriers such as limited investment, infrastructure constraints, and regulatory hurdles.”
Seeds not cells
Plant-based systems can also help biopharma address one of the major challenges of working in the global south—the need for extensive cold chain logistics infrastructure.
Mammalian cells are sensitive to environmental conditions and, as a result, manufacturers use temperature-controlled environments to prevent damage. These concerns are less of an issue for plant-based systems produced from seeds.
“Seed-based platforms offer a strategic advantage by enabling ambient-temperature storage of recombinant proteins for extended periods without loss of bioactivity. This capability significantly reduces cold-chain dependency and enhances logistical resilience in resource-limited settings.
“Consequently,” the authors continue, “plant-based expression systems represent a premier, cost-effective pathway for the large-scale production of biologics.”
The post Plant Expression Platforms May Be Better Option for Biopharma in the Global South appeared first on GEN – Genetic Engineering and Biotechnology News.
Impact of an Artificial Intelligence–Powered Clinical Decision Support System for Acute Kidney Injury Prevention in the Intensive Care Unit: Single-Center Uncontrolled Before-and-After Implementation Study
Background: Acute kidney injury (AKI) is a frequent and serious complication among hospitalized patients, particularly in critical care settings, where its incidence can exceed 50%. AKI is associated with increased mortality, prolonged hospitalization, dialysis dependence, and higher health care costs. Although the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines emphasize supportive care, hemodynamic optimization, and avoidance of nephrotoxins, their implementation remains inconsistent, partly due to the lack of timely risk stratification. Recent advances in artificial intelligence have enhanced early prediction and detection of AKI, offering new opportunities to improve patient outcomes and intensive care unit (ICU) efficiency. The U-Care Renal Platform (UCRP; U-Care Medical S.r.l), a Conformité Européenne (CE)–marked artificial intelligence–powered medical device, integrates directly with the ICU electronic health record to continuously analyze patient data and predict the risk of moderate or severe AKI within 24 hours, providing actionable, guideline-based recommendations. While the predictive performance of UCRP has been validated previously, its real-world impact on clinical and operational outcomes in the ICU remains underexplored. Objective: This single-center uncontrolled before-and-after implementation study aims to evaluate the association between UCRP implementation and selected ICU clinical and operational outcomes in routine practice at SCIAS Hospital, Barcelona. Methods: This study was conducted as a retrospective service evaluation of a workflow-embedded clinical decision support system between March 2023 and March 2025. It included 202 postsurgical adult ICU patients. Outcomes of interest were assessed by comparing preimplementation and postimplementation periods. Months during which the UCRP was inactive were excluded from the analysis (total excluded duration: 10 months; 5 in the preimplementation period and 5 in the postimplementation period). The outcomes included the incidence of moderate-to-severe AKI (KDIGO stages 2 and 3), the use of nephrotoxic medications, the frequency of hypotensive episodes among patients with AKI, and the ICU length of stay. Results: During the postimplementation period, lower rates of moderate-to-severe AKI (9/99, 9.1% vs 12/103, 11.7%), nephrotoxic drug administration, and hypotensive episodes among patients with AKI were observed compared with the preimplementation period. Conclusions: Integration of the UCRP into ICU workflows was associated with differences in selected AKI-related process and intermediate clinical outcomes in this single-center uncontrolled before-and-after implementation study. However, given the study design, causal relationships cannot be established, and the findings should be interpreted as preliminary signals requiring confirmation in larger, controlled, and multicenter studies, including patient-centered outcomes.
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