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

Purpose: Routine manual tracing of cardiac contours is time-consuming and subject to variability. A fully automated software tool may improve reading efficiency. This study was performed to assess the accuracy, reliability, and time-efficiency of a fully automated left ventricular (LV) segmentation software tool to calculate LV volumes and function compared with conventional manual contouring.

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Aims: Abdominal hypopressive technique (AHT) is gaining popularity as an alternative to pelvic floor muscle training (PFMT) during postpartum. Although, there is no solid evidence for its recommendation.

Methods: We conducted a prospective observational cohort study in a university hospital with 105 primiparae who performed a two-month PFMT or AHT program.

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Disease control at 5 years would be a desirable endpoint for elderly multiple myeloma (MM) patients, but biomarkers predicting this are not defined. Therefore, to gain further insights in this endpoint, a population of 498 newly diagnosed transplant-ineligible patients enrolled in two Spanish trials (GEM2005MAS65 and GEM2010MAS65), has been analyzed. Among the 435 patients included in this post-hoc study, 18.

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Background And Aims: Obesity is associated with impaired glucose tolerance which is a risk factor for cardiovascular risk. However, the oral glucose tolerance test (OGTT) is not usually performed in patients with normal fasting glycaemia, thus offering false reassurance to patients with overweight or obesity who may have post-prandial hyperglycaemia. As an alternative to resource demanding OGTTs, we aimed to examine the predictive value of anthropometric measures of total and central fat distribution for post-prandial hyperglycaemia in patients with overweight and obesity with normal fasting glycaemia enrolled in the DICAMANO study.

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Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial.

J Allergy Clin Immunol Pract

August 2020

Department of Allergy and Clinical Immunology, Clinica Universidad de Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain; RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain. Electronic address:

Background: Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.

Objective: To explore the safety and efficacy of omalizumab in controlling UCOL.

Methods: We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines.

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Background: Mesenchymal stromal cells (MSCs) are a promising option to treat knee osteoarthritis (OA). Their safety and usefulness have been reported in several short-term clinical trials but less information is available on the long-term effects of MSC in patients with osteoarthritis. We have evaluated patients included in our previous randomized clinical trial (CMM-ART, NCT02123368) to determine their long-term clinical effect.

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Objectives: To evaluate the relationship between pharmacokinetic descriptors of dexmedetomidine (predicted area under the curve during the procedure, predicted plasma level at the end of the procedure, and duration of procedure) and sedation depth (proportion of time with bispectral index < 85 during the procedure) with recovery time after ambulatory procedures.

Materials And Methods: Clinical observational study of patients undergoing oral and maxillofacial ambulatory surgery with dexmedetomidine as sole sedative agent. Patients received a loading dose of dexmedetomidine (0.

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Background: Differentiating between immunoglobulin E (IgE)-dependent and IgE-independent hypersensitivity reactions may improve the etiologic orientation and clinical management of patients with allergic reactions in the anesthesia setting. Serum tryptase levels may be useful to discriminate the immune mechanism of allergic reactions, but the diagnostic accuracy and optimal cutpoint remain unclear.We aimed to compare the diagnostic accuracy of tryptase during reaction (TDR) alone and the TDR/basal tryptase (TDR/BT) ratio for discriminating IgE- from non-IgE-mediated allergic reactions, and to estimate the best cut point for these indicators.

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Background: Corticosteroids are routinely used to treat brain tumors. Although steroids have an immediate clinical benefit, their use can lead to a number of relevant complications, and a negative association with overall survival has been shown in glioblastoma (GBM) patients. There is no evidence in the literature regarding the ideal dose.

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Omalizumab (OmAb) is a humanized anti-IgE antibody approved for the treatment of chronic spontaneous urticaria (CSU). OmAb's mechanism of action is known to include actions on free IgE and on pre-bound IgE. However, OmAb is equally and rapidly effective against autoimmune and non-autoimmune urticaria where IgE involvement is not clear, suggesting the involvement of additional mechanisms of action.

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Objective: To understand the degree of technological implementation in the processes of preparation and administration of cytostatics drugs that is available in those hospitals of the Autonomous Community of Madrid where intravenous chemotherapy is prepared.

Method: A descriptive observational study through the completion of a survey targeted to the staff responsible for the preparation of this type of treatments.

Results: The degree of implementation of assisted electronic prescription is high, there is a medium degree in the case of bar code reading technology, and low in terms of vial re-labelling and gravimetric and voice control for preparation.

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Effect of Dexmedetomidine and Propofol on Basal Ganglia Activity in Parkinson Disease: A Controlled Clinical Trial.

Anesthesiology

June 2017

From the Department of Anesthesia, Perioperative Medicine and Critical Care (A.M.-S., C.H-C., E.C.-A.), Department of Neurophysiology (M.A.), Research Support Service, Central Clinical Trials Unit (J.M.N.-C), Department of Neurology (M.C.-A.), and Department of Neurosurgery (J.G.), University of Navarra Clinic, Pamplona, Spain; and Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy and Nutrition (I.F.T.) and Neurophysiology Laboratory, Center for Applied Medical Research (M.V.), University of Navarra, Pamplona, Spain.

Background: Deep brain stimulation electrodes can record oscillatory activity from deep brain structures, known as local field potentials. The authors' objective was to evaluate and quantify the effects of dexmedetomidine (0.2 μg·kg·h) on local field potentials in patients with Parkinson disease undergoing deep brain stimulation surgery compared with control recording (primary outcome), as well as the effect of propofol at different estimated peak effect site concentrations (0.

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Is HOMA-IR a potential screening test for non-alcoholic fatty liver disease in adults with type 2 diabetes?

Eur J Intern Med

June 2017

Clínica Universidad de Navarra, Department of Endocrinology and Nutrition, Avenida Pío XII, 31008 Pamplona, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain; Diabetes & Metabolic Diseases Group, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.

Background: Non-alcoholic fatty liver disease (NAFLD) is the commonest hepatic disease in many parts of the World, with particularly high prevalence in patients with type 2 diabetes (T2DM). However, a good screening test for NAFLD in T2DM has not been established. Insulin resistance (IR) has been associated with NAFLD, and homeostatic model assessment of insulin resistance (HOMA-IR), a good proxy for IR, may represent an affordable predictive test which could be easily applied in routine clinical practice.

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Background: Laparoscopic organ-sparing pancreatectomy (LOSP) is an ideal therapeutic option in selected cases of pancreatic neuroendocrine tumors (PNETs). Nevertheless, given the low frequency of PNETs, there is scarce evidence regarding short and particularly long-term outcomes of LOSP in this clinical setting.

Methods: All patients with PNETs who underwent surgery (under a LOSP policy) were retrospectively reviewed from a prospective database maintained at our center.

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External validation of predictive models for acute kidney injury following cardiac surgery: A prospective multicentre cohort study.

Eur J Anaesthesiol

February 2017

From the Department of Anesthesia and Critical Care, University of Navarra Clinic, University of Navarra (GE, PD-S, RC, MJI, PM), the Service of Nephrology, University of Navarra Clinic, University of Navarra (NG-F), and Research Support Service, Central Clinical Trials Unit, University of Navarra Clinic, University of Navarra, Pamplona, Spain (JMN-C).

Background: Four predictive models for acute kidney injury associated with cardiac surgery were developed by Demirjian in the United States in 2012. However, the usefulness of these models in clinical practice needs to be established in different populations independent of that used to develop the models.

Objectives: Our aim was to evaluate the predictive performance of these models in a Spanish population.

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Background: Mesenchymal stromal cells are a promising option to treat knee osteoarthritis. Their safety and usefulness must be confirmed and the optimal dose established. We tested increasing doses of bone marrow mesenchymal stromal cells (BM-MSCs) in combination with hyaluronic acid in a randomized clinical trial.

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Background: A major drawback of lung cancer screening programs is the high frequency of false-positive findings on computed tomography (CT). We investigated the accuracy of selective 2-[fluorine-18]-fluoro-2-deoxy-d-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan in assessing radiologically indeterminate lung nodules detected in lung cancer screening.

Methods: FDG PET/CT was performed to characterize 64 baseline lung nodules >10mm and 36 incidence nodules detected on low-dose CT screening in asymptomatic current or former smokers (83 men, age range 40-83 years) at high risk for lung cancer.

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Barriers to promote cardiovascular health in community pharmacies: a systematic review.

Health Promot Int

June 2017

Division of Biostatistics, Research Support Service, Central Clinical Trials Unit, University of Navarra Clinic, Pamplona, Spain.

Community pharmacists play an important role in the provision of health promotion services, and community pharmacies are considered as a potentially ideal site for cardiovascular health promotion. Information based on a systematic review of barriers to promoting cardiovascular health in community pharmacy is currently lacking. We have sought to identify the most important barriers to cardiovascular health promotion in the community pharmacy.

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Background: Intermediate Care Units (ImCU) have become an alternative scenario to perform Non-Invasive Ventilation (NIV). The limited number of prognostic studies in this population support the need of mortality prediction evaluation in this context.

Objective: The objective of this study is to analyze the performance of Simplified Acute Physiology Score (SAPS) II and 3 in patients undergoing NIV in an ImCU.

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