Clinical trials

9

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Condition / disease
Location
Status: Recruiting

Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)

PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD). Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2/OP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment. Patients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2/OP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \<55 mg/dL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.

Participants needed: 1,944
Trial details
Phase: Phase 4Age: 50+Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: May 28, 2026Locations: 17
Eligibility criteria

Patients aged ≥50 years who have provided written informed consent. [+5]

Presence of previous cardiovascular events, type 2 diabetes mellitus, familial h... [+2]

Status: Not yet recruiting

Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)

Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomized study evaluates the safety and efficacy of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.

Participants needed: 126
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: May 8, 2026
Eligibility criteria

Age ≥ 18 years [+3]

Vascular anatomy unsuitable for balloon guide catheter placement [+10]

Status: Not yet recruiting

Randomized a Clinical Trial With Medical Device in Acute Ischemic Stroke

This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.

Participants needed: 220
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: Aug 8, 2025Locations: 3
Eligibility criteria

Age ≥ 18 [+5]

Absence of occlusion [+3]

Status: Recruiting

Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM)

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.

Participants needed: 330
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: Apr 3, 2025Locations: 11
Eligibility criteria

Age between 18 and 85 years. [+4]

Cirrhotic patients with acute-on-chronic liver failure (ACLF) as defined by EASL... [+9]

Status: Recruiting

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.

Participants needed: 215
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: Dec 31, 2024Locations: 1
Eligibility criteria

Residents aged 65 and older diagnosed with MCI, able to provide informed consent...

Individuals with severe cognitive impairment, unstable medical conditions, or ps...

Status: Recruiting

OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Obstructive Sleep Apnea (OSA) is a prevalent nocturnal breathing disorder among the general population. Oropharyngeal myofunctional therapy (OMT) is an alternative conservative treatment used to improve OSA, associated health problems, and to improve the efficacy and tolerability of CPAP. The objective is to determine the effect of OMT in the general population with mild-moderate OSA. The overall study design will be a randomized controlled clinical trial with parallel groups. Both the control group and the intervention group will receive the same indications on the hygienic-dietary measures to be followed. The intervention group will also follow an exercise program based on OMT for 20 weeks. The effect on the apnea-hypopnea index and other variables will be determined by means of respiratory polygraphy before and after the intervention.

Participants needed: 30
Trial details
Phase: Phase 3Age: 18-70Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: Nov 14, 2024Locations: 1
Eligibility criteria

Acceptance and signature of the informed consent [+3]

Craniofacial malformations. Severe developmental delay. Intellectual disability. [+8]

Status: Recruiting

Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.

This research project is a descriptive, longitudinal prospective observational study in the HUMV neurosurgery operating rooms. The patients included will be adults 18 years old or older, who will be scheduled for surgery by the Neurosurgery service. Those who meet the selection criteria determined for this study will be chosen consecutively and will be followed from the immediate preoperative moment until 72 hours after the end of the surgery. Data collection shall be carried out by direct observation and immersion in clinical records of patients who have signed the informed consent. The study will be carried out in 4 phases: immediate preoperative, intraoperative, immediate postoperative and late postoperative, recording the data using various measuring instruments, and a record sheet. Finally, the cumulative incidence of LPPs developed in the perioperative environment will be calculated and a statistical analysis will be performed.

Participants needed: 170
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: Sep 26, 2024Locations: 2
Eligibility criteria

Patients who understand and sign the informed consent. [+4]

Patients who do not sign informed consent. [+8]

Status: Recruiting

Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.

Participants needed: 15
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: Aug 28, 2024Locations: 1
Eligibility criteria

Adult patients who received an alogeneic stem cell transplantation from haploide... [+8]

Patients without haploidentical CMV-seropositive donors. [+11]

Status: Recruiting

A Population-based Cohort in Northern Spain

Cantabria Cohort stems from a research and action initiative lead by researchers from Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital and University of Cantabria, supported by the regional Goverment. Its aim is to identify and follow up a cohort that would provide information to improve the understanding of the etiology and prognosis of different acute and chronic diseases. The Cantabria Cohort will recruit between 40,000-50,000 residents aged 40-69 years at baseline, representing 10-20% of the target population. Currently, more than 22,000 volunteers have been enrolled. All participants will be invited for a re-assessment every three years, while the overall duration is planned for twenty years. The repeated collection of biomaterials combined with broad information from participant questionnaires, medical examinations, actual health system records and other secondary public data sources is a major strength of its design, which will make it possible to address biological pathways of disease development, identify new factors involved in health and disease, design new strategies for disease prevention, and advance precision medicine. It is conceived to allow access to a large number of researchers worldwide to boost collaboration and medical research.

Participants needed: 22,000
Trial details
Age: 40-69Biological sex: AllType: ObservationalSponsor: Instituto de Investigación Marqués de ValdecillaUpdated: May 12, 2023Locations: 1
Eligibility criteria

Participants between 40-69 years of age [+2]

Participants under 40 years of age and over 69 years of age [+2]