47 results match your criteria: "Central Clinical Trials Unit[Affiliation]"

Article Synopsis
  • An association between granuloma annulare (GA) and dyslipidaemia was studied, focusing on adipophilin as a potential skin biomarker for dyslipidaemia in GA patients.
  • Of the 107 patients analyzed, those with positive adipophilin staining had a significantly higher prevalence of dyslipidaemia compared to those with negative staining (62.3% vs 13.3%).
  • The research indicated that patients with positive adipophilin expression were ten times more likely to have dyslipidaemia and had a nearly nine-fold increase in risk for developing it over time.
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Association between pre-operative hyperuricemia and risk of in-hospital death in high-risk patients undergoing cardiac surgery: An international prospective 14-centre study.

Eur J Anaesthesiol

June 2024

From the Department of Anaesthesia & Perioperative Medicine, Grupo Quirón - Policlínica Guipúzcoa, San Sebastián (DN), Department of Neurology, Clínica San Miguel, Pamplona (MM-F), Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona (JMN-C), Department of Anesthesiology & Critical Care Medicine, Clínica Universidad de Navarra, Pamplona, Spain (MV).

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Effect of sugammadex on processed EEG parameters in patients undergoing robot-assisted radical prostatectomy.

Br J Anaesth

September 2023

Department of Anaesthesia and Critical Care, Clínica Universidad de Navarra, Pamplona, Spain; IdiSNA, Navarra Institute for Health Research, 31080, Pamplona, Spain.

Background: Sugammadex has been associated with increases in the bispectral index (BIS). We evaluated the effects of sugammadex administration on quantitative electroencephalographic (EEG) and electromyographic (EMG) measures.

Methods: We performed a prospective observational study of adult male patients undergoing robot-assisted radical prostatectomy.

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Cardiometabolic characterization in metabolic dysfunction-associated fatty liver disease.

Front Med (Lausanne)

October 2022

Department of Endocrinology and Nutrition, Clínica Universidad de Navarra, Pamplona, Spain.

Background: To better understand the patient's heterogeneity in fatty liver disease (FLD), metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed by international experts as a new nomenclature for nonalcoholic fatty liver disease (NAFLD). We aimed to evaluate the cardiovascular risk, assessed through coronary artery calcium (CAC) and epicardial adipose tissue (EAT), of patients without FLD and patients with FLD and its different subtypes.

Methods: Cross sectional study of 370 patients.

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C-Methionine PET/CT in Assessment of Multiple Myeloma Patients: Comparison to F-FDG PET/CT and Prognostic Value.

Int J Mol Sci

August 2022

Department of Nuclear Medicine, Clinica Universidad de Navarra, CCUN Applied Medical Research, Instituto de Investigación Sanitaria de Navarra, 31008 Pamplona, Spain.

Multiple myeloma (MM) is the second most common haematological malignancy and remains incurable despite therapeutic advances. F-FDG (FDG) PET/CT is a relevant tool MM for staging and it is the reference imaging technique for treatment evaluation. However, it has limitations, and investigation of other PET tracers is required.

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Wrong surgery (wrong-site, wrong-procedure, or wrong-patient surgery) is among the most feared patient safety problems in hospitals. We aimed to evaluate associations between numeric assessment of risk assigned to wrong surgery with that of other healthcare quality and patient safety challenges. This nationwide study collected information from healthcare quality experts in charge of a clinical quality and/or patient safety department in general hospitals of ≥ 150 beds in Spain.

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Oncolytic DNX-2401 Virus for Pediatric Diffuse Intrinsic Pontine Glioma.

N Engl J Med

June 2022

From the Health Research Institute of Navarra (J.G.P.-L., M.G.-M., S.L., A.P.-G., M.G.-H., M.Z., L.M., N.M.-V., M.P., V.L., S.H.-S., I.T., B.T., R.H.-A., M.V., C.A., S.T., M.M.A.), the Program in Solid Tumors (J.G.P.-L., M.G.-M., S.L., A.P.-G., M.G.-H., M.Z., L.M., N.M.-V., M.P., V.L., B.T., S.T., M.M.A.), the Program in Immunology (S.H.-S.), and the Program in Gene Therapy and Regulation of Gene Expression (R.H.-A.), Foundation for the Applied Medical Research, the Departments of Neurology (J.G.P.-L., I.E.V.), Pediatrics (M.G.-M., S.L., A.P.-G., M.G.-H., M.Z., L.M., N.M.-V., M.P., V.L., M.M.A.), Pathology (M.V., C.A.), and Neurosurgery (S.T.) and the Division of Biostatistics, Research Support Service, Central Clinical Trials Unit (J.M.N.-C.), Clínica Universidad de Navarra, the Service of Pediatric Hemato-Oncology, Hospital Universitario de Navarra (M.O.L.), Center for Applied Medical Research (CIMA) LAB Diagnostics, University of Navarra and Healthcare Research Institute of Navarra (G.A.-A.), and the Bioinformatics Platform, CIMA, University of Navarra (I.T.), Pamplona, the Department of Pediatric Oncology, Biocruces Bizkaia Health Research Institute, Barakaldo (I.A.), the Pediatric Department, Faculty of Medicine and Nursing, University of the Basque Country, Leioa (I.A.), the Department of Pediatric Oncology, Montepríncipe Hospital (B.L.-I.), the Department of Neurosurgery, Quirón Hospitals (R.D.-V., S.T.), and Centro de Investigación Biomédica en Red de Cáncer (M.V.), Madrid, the Department of Pediatric Oncology, Neuro-Oncology Unit, Hospital Sant Joan de Deu, Barcelona (O.C.), and the Department of Pathology, University Hospital Virgen Macarena and School of Medicine, University of Seville, Seville (M.Á.I.) - all in Spain; DNAtrix, Carlsbad, CA (J.D., B.E., J.R.); the Division of Molecular Pathology, Institute of Cancer Research, London (C.J.); the Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (G.D., C.R.-M., H.S., E.H., J.L.); and the Departments of Neuro-Oncology (J.F., C.G.-M.) and Neurosurgery (F.F.L.), University of Texas M.D. Anderson Cancer Center, Houston.

Article Synopsis
  • - Pediatric patients with diffuse intrinsic pontine glioma (DIPG) have a poor prognosis, with less than 1-year median survival; studies on oncolytic viral therapy like DNX-2401 for DIPG are limited.
  • - A single-center study administered DNX-2401 to 12 newly diagnosed DIPG patients to assess safety, adverse events, and effectiveness, with treatments including a virus infusion and radiotherapy.
  • - Results showed that DNX-2401 led to tumor size reduction in 9 patients and a median survival of 17.8 months, with some patients experiencing changes in their tumor microenvironment and immune response.
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Non-alcoholic fatty liver disease (NAFLD) is associated with cardiovascular disease morbimortality. However, it is not clear if NAFLD staging may help identify early or subclinical markers of cardiovascular disease. We aimed to evaluate the association of liver stiffness and serum markers of liver fibrosis with epicardial adipose tissue (EAT) and coronary artery calcium (CAC) in an observational cross-sectional study of 49 NAFLD patients that were seen at Clínica Universidad de Navarra (Spain) between 2009 and 2019.

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COVID-19 publications in anaesthesiology journals: a bibliometric analysis.

Br J Anaesth

March 2022

Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain; Institute of Data Science and Artificial Intelligence, University of Navarra, Pamplona, Spain. Electronic address:

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Background: The identification of factors associated with perioperative red blood cell (RBC) transfusion provides an opportunity to optimize the patient and surgical plan, and to guide perioperative crossmatch and RBC orders. We examined the association among potential bleeding risk factors and RBC requirements to develop a novel predictive model for RBC transfusion in patients undergoing brain tumor surgery.

Methods: This retrospective study included 696 adults who underwent brain tumor surgery between 2008 and 2018.

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Background: During magnetic resonance-guided focused ultrasound for essential or parkinsonian tremor, adverse events (headache, nausea/vomiting, or anxiety) may alter the outcome of the procedure despite being mostly transient and mild.

Objectives: Our aim was to analyze the relationship between demographic, procedural, and anesthetic characteristics with magnetic resonance/ultrasound-related events.

Methods: This was a retrospective study at the Clinica Universidad de Navarra of patients undergoing thalamotomy with magnetic resonance-guided focused ultrasound between September 2018 and October 2019.

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Article Synopsis
  • Idiopathic pulmonary fibrosis (IPF) is a serious condition, and this study focused on using mesenchymal stromal cells (MSCs) to treat it, as MSCs have shown promise in other inflammatory diseases.
  • A phase I clinical trial evaluated the safety of administering bone marrow-derived MSCs (BM-MSCs) directly into the lungs of patients with mild-to-moderate IPF, monitoring their pulmonary function over a year.
  • While there were no severe adverse effects from the treatment, many patients experienced clinical progression, and some exhibited genomic instability in the cultured BM-MSCs, raising concerns about their use.
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Background: Dexmedetomidine is frequently used for sedation during deep brain stimulator implantation in patients with Parkinson's disease, but its effect on subthalamic nucleus activity is not well known. The aim of this study was to quantify the effect of increasing doses of dexmedetomidine in this population.

Methods: Controlled clinical trial assessing changes in subthalamic activity with increasing doses of dexmedetomidine (from 0.

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Aims: To identify and prioritize the root causes of adverse drug events (ADEs) in hospitals and to assess the ability of artificial intelligence (AI) capabilities to prevent ADEs.

Design: A mixed method design was used.

Methods: A cross-sectional study for hospitals in Spain was carried out between February and April 2019 to identify and prioritize the root causes of ADEs.

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Background: Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 10 bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial.

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Background: Glioblastoma (GBM) is the most common malignant primary brain tumor in adults. Circulating biomarkers may assist in the processes of differential diagnosis and response assessment. GBM cells release extracellular vesicles containing a subset of proteins and nucleic acids.

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Anti-cluster of differentiation 20 (CD20) monoclonal antibodies (mAbs) have shown promise in follicular lymphoma (FL) as post-induction therapy, by enhancing antibody-dependent cellular cytotoxicity (ADCC). However, cytotoxic cells are reduced after this treatment. We hypothesised that ex vivo expanded lymphokine-activated killer (LAK) cells administered to FL-remission patients are safe and improve anti-CD20 efficacy.

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Background: Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR.

Objectives: To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR.

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