The assessment of post-procedural bleeding risk in cirrhosis remains a clinical challenge due to the lack of precise predictive tools and its high associated mortality. Although guidelines recommend a restrictive transfusion policy, adherence remains low, with a high rate of prophylactic transfusions despite unclear benefits. This multicenter, prospective, and observational study will evaluate the utility of ROTEM in bleeding risk stratification for cirrhotic patients with significant abnormalities in conventional hemostasis tests undergoing high-risk invasive procedures. The primary objective is to establish cut-off values with a high negative predictive value, optimizing transfusion decisions and reducing unnecessary blood product use. Additionally, the study will analyze the relationship between ROTEM, inflammation biomarkers, and coagulation factors, along with a cost-effectiveness analysis comparing different transfusion strategies. This will be the largest study to date assessing ROTEM in this setting, overcoming the limitations of previous studies, which have been mostly retrospective with heterogeneous populations and procedures. Its findings could contribute to the standardization of transfusion management in cirrhosis and improve healthcare resource efficiency. The widespread availability of ROTEM in other disciplines within the National Health System will facilitate its implementation in this clinical setting without requiring additional investment in equipment.

Start Date01 Mar 2025

Sponsor / Collaborator

Instituto de investigación sanitaria Valdecilla

NCT06753578

/ RecruitingNot ApplicableIIT

Effectiveness of an ACT-Based Cognitive Intervention on Quality of Life and Cognitive Function in Elderly Residents With MCI

This study investigates the effects of an Acceptance and Commitment Therapy (ACT)-based cognitive intervention on Quality of Life (QOL) and cognitive function among elderly residents with Mild Cognitive Impairment (MCI) in long-term care settings. The study assesses immediate and long-term impacts on cognitive function, psychological flexibility, social engagement, and overall well-being through structured ACT-based training.

Start Date01 Jan 2024

Sponsor / Collaborator

Instituto de investigación sanitaria Valdecilla

NCT05622526

/ Not yet recruitingPhase 2IIT

Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer by Capsules vs. Placebo for the Treatment of Patients With Nonalcoholic Steatohepatitis

The EMOTION study is a multicentric, double-blind, controlled, parallel-group, phase IIa randomized Clinical trial to evaluate the efficacy, safety and tolerability of TMF capsules for the treatment of patients with NASH.
The clinical trial has two stages:
Screening phase with a duration of 12 weeks to classify patients based on lifestyle modifications.
Treatment phase where patients will be randomized and stratified 2:1 to treatment:
Experimental for n=64 patients.
Placebo control for n=32 patients.

Start Date01 Jan 2024

Sponsor / Collaborator

Instituto de investigación sanitaria Valdecilla

100 Clinical Results associated with Instituto de investigación sanitaria Valdecilla

0 Patents (Medical) associated with Instituto de investigación sanitaria Valdecilla

234

Literatures (Medical) associated with Instituto de investigación sanitaria Valdecilla

01 Sep 2025·Talanta

Comprehensive Raman spectroscopy analysis for differentiating toxic cyanobacteria through multichannel 1D-CNNs and SHAP-based explainability

Article

Author: Ocampo-Sosa, Alain A ; Cobo, Adolfo ; Monteoliva, Agustín P ; López-Higuera, José Miguel ; Algorri, José Francisco ; Álvarez, Susana Deus ; Gómez-Galdós, Celia ; Fernández-Manteca, María Gabriela ; Rodríguez-Cobo, Luis ; García, Borja García ; Pérez-Asensio, Andrea

Cyanobacterial blooms pose significant environmental and public health risks due to the production of toxins that contaminate water sources and disrupt aquatic ecosystems. Rapid and accurate identification of cyanobacterial species is crucial for effective monitoring and management strategies. In this study, we combined Raman spectroscopy with deep learning techniques to classify four toxic cyanobacterial species: Dolichospermum crassum, Aphanizomenon sp., Planktothrix agardhii and Microcystis aeruginosa. Spectral data were acquired using a confocal Raman microscope with a 532 nm excitation wavelength and subjected to preprocessing and filtering to enhance signal quality. We evaluated a multichannel one-dimensional convolutional neural network (1D-CNN) approach that incorporates raw spectra, baseline estimations, and preprocessed spectra. This multichannel approach improved overall classification accuracy, achieving 86% compared to 74% with a traditional single-channel 1D-CNN using only preprocessed spectra while maintaining low overfitting. Shapley Additive exPlanations (SHAP) were applied to identify critical spectral regions for classification to enhance interpretability. These findings highlight the potential of combining Raman spectroscopy with explainable deep learning methods as a powerful tool for water quality monitoring and the early detection of Harmful Algal Blooms (HABs).

01 May 2025·Annals of Nuclear Medicine

FAPI radiopharmaceuticals in nuclear oncology and theranostics of solid tumours: are we nearer to surrounding the hallmarks of cancer?

Review

Author: García Megías, Irene ; Pabst, Kim M ; Delgado Bolton, Roberto C ; Calapaquí Terán, Adriana K ; Herrmann, Ken ; Giammarile, Francesco ; Almeida, Ludmila Santiago

Abstract[18F]FDG PET/CT is the most widely used PET radiopharmaceutical in oncology, but it is not exempt of diagnostic limitations. FAPI have emerged as a great tool in the management of several different solid tumours in which [18F]FDG is not able to provide enough information. The aim of this work was to evaluate the available evidence on diagnostic and therapeutic applications of PET/CT with FAPI radiopharmaceuticals. We underwent a non-systematic review focusing in the utility of FAPI radiopharmaceuticals in PET/CT diagnosis and in the treatment of several malignancies. FAPI radiopharmaceuticals present characteristics that can potentially overcome some known diagnostic limitations of [18F]FDG. FAPI radiopharmaceuticals present a high target-to-background ratio (TBR) in many solid tumours such as oesophageal cancer, gastric cancer, pancreatic cancer, hepatic cancer, colorectal cancer, breast cancer, ovarian, cervical cancer, and head and neck cancer. Available evidence suggests the high TBR improves sensitivity and specificity compared to [18F]FDG, especially for the detection of lymphadenopathies and peritoneal metastases, and may improve patient management and radiation treatment planning. Moreover, it is important to underline the potential theranostic application of FAPI radiopharmaceuticals.

01 May 2025·Clinical Microbiology and Infection

Ceftaroline for bloodstream infections caused by methicillin-resistant Staphylococcus aureus: a multicentre retrospective cohort study

Article

Author: Grau, Inmaculada ; García-Tellado, Alex ; Fiorante, Silvana ; Cabezón, Itxasne ; Díaz-Pollán, Beatriz ; Guerra-Laso, José Manuel ; Urbina, Luciana ; Berbel, Damaris ; Sanz-Peláez, Oscar ; Boix-Palop, Lucía ; Buzón-Martín, Luis ; Halperin, Ana V. ; Viñado, Belén ; Silvante, Fiorana ; Escudero-Sánchez, Rosa ; Ramos-Merino, Lucía ; Pérez-Rodríguez, María Teresa ; Eworo, Alia ; Escrihuela-Vidal, Francesc ; Fernández-Hidalgo, Nuria ; Rio, Lara del ; Xercavins, Mariona ; Muñoz, Patricia ; Ferrando, Valeria ; Crespo, Ángela ; Villa, Sofía de la ; García-País, María José ; Goikoetxea, Ane Josune ; De La Villa, Sofía ; Rodríguez, Sara ; Campany, David ; Sánchez-Martínez, Celia ; Roig-Sanchis, Joan

OBJECTIVESTo evaluate the effectiveness of ceftaroline vs. vancomycin or daptomycin in the treatment of methicillin-resistant Staphylococcus aureus bloodstream infections (BSIs) (MRSA-BSIs).METHODSThis multicentre retrospective study conducted in 15 Spanish hospitals included data from the first MRSA-BSIs of adult patients between January 2019 and December 2022. The ceftaroline group included patients who received ceftaroline for ≥72 hours within the first week of BSI onset; the standard-of-care (SOC) group included patients who received vancomycin or daptomycin ≥72 hours after BSI onset. Primary outcome was 30-day all-cause mortality; secondary outcomes included 90-day mortality and incidence of adverse events (AEs). Propensity-score matching and Cox proportional hazards analyses were performed.RESULTSA total of 429 MRSA-BSIs were included: 133 in the ceftaroline group and 296 in the SOC group. More patients in the ceftaroline group had a Sequential Organ Failure Assessment score >2 (51.1% vs. 36.5%; p < 0.01), complicated BSI (66.2% vs. 42.2%; p < 0.01), infective endocarditis (18.8% vs. 6.4%; p < 0.01) and prescribed in combination treatment (65.4% vs. 11.5%; p < 0.01), with no statistically significant differences in 30-day mortality: 23.3% ceftaroline (95% CI, 16.1-30.5%) vs. 16.2% SOC (95% CI, 12.0-20.4%), p 0.08. There were no statistically significant differences in 90-day mortality (33.1% ceftaroline vs. 26.7% SOC; p 0.17). After propensity-score matching, 105 patients treated with ceftaroline were matched with 105 controls: the 30-day mortality rates were 21.9% and 16.2% (p 0.38). Cox regression analysis of the entire cohort (n = 429) revealed that age (hazard ratio [HR], 1.05; 95% CI, 1.03-1.07) and Sequential Organ Failure Assessment score >2 (HR, 2.34; 95% CI, 1.50-3.65) were associated with 90-day mortality risk, although ceftaroline treatment did not demonstrate a significant effect (HR, 1.00; 95% CI, 0.97-1.02). Incidence of AEs was 12.0% in ceftaroline vs. 4.4% in the SOC group (p < 0.01). Most AEs occurred when ceftaroline was used in combination vs. monotherapy (17.2% vs. 2.2%; p 0.01).DISCUSSIONCeftaroline was an effective treatment for MRSA-BSIs but was commonly prescribed in combination showing a higher incidence of AEs.

100 Deals associated with Instituto de investigación sanitaria Valdecilla

100 Translational Medicine associated with Instituto de investigación sanitaria Valdecilla

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Drug(Targets)	Indications	Global Highest Phase

anti-CMV Cytolitic T Lymphocytes (Instituto de Investigación Marqués de Valdecilla)	Cytomegalovirus Infections More	Phase 2

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