Clinical Trials associated with USP Institut Universitari Dexeus
NCT05836974
/ CompletedNot ApplicableIIT
Performance Evaluation of the ex Utero Cord Blood Collection Technique: Procedure, Quality and Results
Umbilical cord blood (UCB) is used for leukemia patients and other serious blood disorders worldwide. (3) It has also been recently used for other therapeutic applications such as wound treatment, red blood cell transfusion, or cellular or regenerative therapy. Until now, cord blood banks have worked to have many units in reserve to offer maximum compatibility with patients. The priority is to increase the quality of cord blood by collecting units that have more stem cells with less contamination so that more patients can benefit, that is, improving the efficiency of the process. The conventional in utero technique allowed for a more rapid diffusion of cord blood donation programs as it does not require accessories or additional personnel to carry it out. The UCB donation program was initiated in Catalonia in 1995, and since then, this has been the technique used (www.bancsang.net/info-corporativa/qui-som). Some comparisons have been made in the scientific literature with the results found . Currently, there are some new applications of UCB that require its use in fresh form, and it would be beneficial to minimize the risk of bacterial contamination that seems to be reduced with ex utero collection. Therefore, the proposition for this study is to confirm equivalence in quality characteristics and create opportunities for its extensive application. Currently, cord blood donation is offered to all expectant mothers, provided that the donor does not have any medical exclusion. A very small number of the collected units are suitable for clinical use once processed, making donation programs truly inefficient. This inefficiency generates a workload and waste of public resources that are limited and can also cause ethical dilemmas. Therefore, new strategies are needed to increase the efficiency of donation programs. The Blood and Tissue Bank (BST) has an efficiency improvement study underway using the ex-utero collection technique. The development of this methodology will allow later to propose expanded collection methods, such as the simultaneous collection of cord blood and placenta. The update of new protocols in childbirth care encourages to explore new systematic umbilical cord blood collection methods with the following objectives: to intervene less in the delivery room obtaining products of equal quality and less contamination and to facilitate the simultaneous donation of UCB and placenta in the future. To ensure that the units have maximum quality, both cellular and free of bacteriology, and can be used safely, the investigators propose the implementation of ex utero cord blood collection. The ex-utero UCB collection involves minimal manipulation, allowing for better cord asepsis. After the birth of the baby and cord clamping at one minute, the investigators wait for the delivery of the placenta and proceed to obtain the ex-utero UCB sample. Thanks to this technique, residual cord blood can be obtained, and the placenta can be collected simultaneously, maintaining the same volume as in in utero collection and reducing contamination and hemolysis of the samples. This technique poses no risk to either the mother or the baby. The ex-utero cord blood collection technique is a validated technique used in different studies. To verify these data in our environment and propose a change in the cord blood collection strategy in public banks, this study has been designed. If the investigators demonstrate that this methodology meets quality objectives, similar to the in-utero technique but significantly reducing associated contamination from the delivery field and the presence of hemolysis, the cord blood bank can implement this new systematic method in centers with highly trained collection personnel, releasing obstetric professionals from their intervention in the delivery room and favoring better quality of the products obtained.
Randomized Trial of Cardioneuroablation in Reflex Syncope Treatment (CARDIOSYE Trial)
Background: Reflex syncope is a disease of benign etiology but in severe cases it can be disabling and it carries a risk of severe trauma. Today, there is no proven etiological treatment and only palliative treatments are used, namely a change in hygienic and dietary habits, certain drugs or, in the most severe cases, the implantation of a pacemaker. Cardioneuroablation is a novel technique that acts by ablating the parasympathetic ganglia located on the external walls of the atria. Several prospective series with promising results have been published, but there are no randomized studies that have validated its efficacy compared to conventional treatment. Methods: The CARDIOSYRE study is a multicenter, randomized, single-blinded study of patients with reflex syncope. The aim is to recruit, between June 2022 and June 2025, 92 patients with reflex cardioinhibitory syncope in 15 centers and randomize them (1:1 ratio) to two treatment groups: 1) cardioneuroablation intervention; 2) conventional treatment (control group). The primary end-point will be the time to the first syncope and the secondary end-point will be the total incidence of syncope after one year of follow-up. At least 20 recurrences of syncope are expected during a 1-year follow-up. A relative risk of 0.3 and a statistical power of 80% are assumed. The follow-up will be carried out at 3, 6 and 12 months. Cox models will be used to estimate adjusted Hazard ratios.
The Voice Analysis as a Preoperative Prediction Method of a Difficult Airway
Before an anesthetic procedure, airway management is essential to ensure adequate ventilation and breathing of the patient during the entire surgical process. The preanesthetic evaluation of the airway allows for proper planning, facilitates the anticipation of human resources and necessary means to face the possible challenges in a safe and efficient way. Orofacial mask ventilation and endotracheal intubation are a crucial step in general anesthesia. Most of the time, management is not complicated, but when an unpredicted difficult airway occurs, it is currently one of the most important challenges to face as an anesthesiologist. These situations are rare as the prevalence of a difficult airway is approximately 2.2% of the general population. When there is a case of a difficult airway and adequate management is not achieved, very serious complications may occur including brain damage, cardio-respiratory arrest, aspiration of gastric content, traumatic airway injuries, tooth damage, unnecessary surgical access to keep the airway permeable or death. For these reasons, in anesthesia, an unforeseen difficult airway is considered a crisis situation. Therefore, a preoperative airway assessment is paramount. Traditional predictive tests evaluate multiple anthropometric characteristics in which the physical presence of the patient is mandatory. However, no test can currently predict a difficult airway based on a single characteristic nor in the patient's absence. Nowadays, the optimization of resources and new technologies have increased interest in developing new tests or methods for preoperatively assessing the difficulty of the airway and new methods of airway evaluation have been proposed. As recently demonstrated, the detection of a difficult airway depends not only on the morphology but also on functional traits of the airway. Some studies propose the analysis of voice parameters as a reflection of anatomical and functional features of the superior airway. The investigators propose that the analysis of voice characteristics could reflect the airway's anatomy and therefore the investigators will be able to predict a difficult airway, and this would enable the development of a voice-based assessment method which could have an promising role in facilitating telematic airway evaluation.
100 Clinical Results associated with USP Institut Universitari Dexeus
Login to view more data
0 Patents (Medical) associated with USP Institut Universitari Dexeus
Login to view more data
52
Literatures (Medical) associated with USP Institut Universitari Dexeus
01 Oct 2018·Annals of Oncology
Combination of the S49076 with gefitinib in NSCLC patients progressing on EGFR-TKI and harboring MET/AXL dysregulation
Article
Author: Curigliano, G ; Park, K ; Murakami, H ; Cattan, V ; Ciardiello, F ; Cho, B C ; Lin, C-C ; Hida, T ; Natsume, I ; Soo, R A ; Heck, H ; Nishio, M ; Lee, D H ; Paz-Ares, L ; Gandossi, E ; Lim, W T D ; Martinez, A ; Viteri, S ; Chang, G-C ; Chiari, R
20 May 2014·Journal of Clinical Oncology
BIM expression in EGFR-mutant non-small cell lung cancer (NSCLC) patients (pts) treated with erlotinib in Colombia.
Author: Arrieta, Oscar ; Cardona, Andres F. ; Karachaliou, Niki ; Vargas, Carlos A. ; Drozdowskyj, Ana ; Rosell, Rafael ; Otero, Jorge M. ; Carranza, Hernan ; Gimenez Capitan, Ana ; Molina-Vila, Miguel Angel
e19098 Background: Tyrosine kinase inhibitors (TKIs) elicit high response rates among individuals with EGFR-mutated NSCLC. However, the extent and duration of these responses are heterogeneous, sug...
20 May 2014·Journal of Clinical Oncology
Effect of BIM and mTOR expression on clinical outcome to erlotinib in EGFR-mutant non-small cell lung cancer (NSCLC) patients (p).
Author: Chaib, Imane ; Morales-Espinosa, Daniela ; Ma, Patrick C. ; Moran, Teresa ; Majem, Margarita ; Massuti, Bartomeu ; Campelo, Rosario Garcia ; Verlicchi, Alberto ; Karachaliou, Niki ; Viteri Ramirez, Santiago ; Gervais, Radj ; Carcereny Costa, Enric ; Gimenez Capitan, Ana ; Cardona Zorrilla, Andres Felipe ; Felip, Enriqueta ; Ramirez, Jose Luis ; Drozdowskyj, Ana ; Crisetti, Elisabetta ; Rosell, Rafael
8072 Background: Sixty percent of EGFR-mutant NSCLC p respond to erlotinib, but overall survival (OS) is the same for upfront chemotherapy. Priming BIM, a pro-apoptotic signaling BH3-only protein, induced sensitivity to erlotinib in EGFR-mutant cell lines (Costa el at. PLoS Med 2007). BIM was related to response and progression-free survival (PFS) in clinical tumor samples, but OS was not reported (Faber et al. Cancer Disc 2011). Mammalian target of rapamycin (mTOR) negatively regulates apoptosis and could influence response to erlotinib. Methods: We assessed static levels of total BIM, BIM-extra long (BIM-EL – a main isoform of BIM), and mTOR mRNA expression and correlated findings with response and OS in 57 erlotinib- or chemotherapy-treated EGFR-mutant NSCLC p in the EURTAC trial. Results: Median age 65; 70.2% female; 59.6% never-smokers; 91.2% adenocarcinoma. Response rate 88.9% for erlotinib-treated p with high total BIM levels, compared to 22.2% with low/intermediate total BIM levels (P=0.0027). Sen...
100 Deals associated with USP Institut Universitari Dexeus
Login to view more data
100 Translational Medicine associated with USP Institut Universitari Dexeus
Login to view more data
Corporation Tree
Boost your research with our corporation tree data.
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.