Clinical trials

The goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters.

To better understand the load distribution in the Thumb Carpometacarpal Joint (CMC joint) in presence of osteoarthritis and how surgery by means of a suspension-resection arthroplasty or a joint replacement by means of a metal prosthesis affects this load distribution. These studies allow to supporting medical decisions and surgical treatments results with biomechanical evidence.The clinical management of the patients will be adapted to the treatment standards of the Orthopedic Surgery and Traumatology Service of the Hospital de la Santa Creu i Sant Pau, without the performance of this study influencing this process.

This research study is a phase Ib/II, single-arm, non-randomized, non-blind, multicenter study designed to determine whether Afatinib is effective and safe in patients with locoregionally unresectable and / or metastatic HNSCC with Fanconi Anemia. The main hypothesis, based on preclinical evidence, is that treatment with afatinib, an epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), could be an effective treatment option to control cancer for patients with FA - HNSCC.

Ischemic necrosis of lunate bone, osteonecrosis or Kienböck´s disease was described by Kienböck in 1910. Numerous surgical procedures for this disease had been proposed. These surgical options, that depends of the radiological stage and anatomical risk factors, can be classified into lunate unloading procedures, lunate revascularization, replacement procedures and salvage procedures. These procedures, except the salvage procedures, has been successful in reconstructing and maintaining the height of the carpus, avoiding progression of the disease and with reduction of the pain. The lunate unloading procedures are surgical treatments that make a radial osteotomy for modify differents anatomical risk factors associated with the osteonecrosis.

This study aims to evaluate differences in cognitive and psychomotor development among preterm infants (born before 34 weeks of gestation) delivered during the COVID-19 pandemic at Hospital de la Santa Creu i Sant Pau, compared with a control group of preterm infants born at the same hospital.

This study evaluates the clinical, organizational, and care impact of the GetReady digital platform as a clinical decision support tool for the follow-up of patients with cerebral aneurysm. The platform integrates clinical, radiological, and patient-reported data, including PROMs and PREMs, and may incorporate home blood pressure monitoring. The study is an interventional implementation study with retrospective and prospective components. No additional medical, diagnostic, or therapeutic intervention is introduced, and all clinical decisions remain under routine clinical practice.

Background: Borderline personality disorder (BPD) is a frequentand serious psychiatric disorder characterized by a persistent pattern of instability in relationships, affect and self-image. Although long-term follow-up prospective studies have shown high clinical remission rates, they also point out that usually persist social functioning deficits, comorbidity, isolation, chronic affective clinic and life dissatisfaction. Self-compassion training (SCT) could be an effective strategy targeting self-criticism, shame and chronic feelings of worthlessness, as well as increasing resilience. In addition, the administration of intranasal oxytocin has proven useful in regulating social cognition, affiliation behaviors and enhancing empathy, key symptoms in this population. This combined intervention could be particularly appropriate for BPD patients. Objective: The objective of this project is to implement and evaluate the effectiveness of a combined intervention, based on SCT and intranasal oxytocin administration, for the treatment of patients with BPD. Methodology: Controlled and randomized clinical trial. A self-compassion training of 5 weeks duration plus intranasal oxytocin administration versus SCT plus placebo will be compared in a sample of 80 patients with BPD. Clinical and wellness measures will be evalutated as outcomes.

This randomized controlled trial compares periarticular vasoconstrictor infiltration (PVI) versus erector spinae plane block (ESP) to reduce bleeding and postoperative pain in adults undergoing lumbar fusion surgery (up to 3 levels). Patients are randomly assigned 1:1 to receive ultrasound-guided ropivacaine 0.2% + epinephrine 1:200,000: PVI (150-200mL bilateral in retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous planes) or ESP (20mL/side at transverse processes). Both groups receive standardized general anesthesia (TIVA), multimodal analgesia (dexamethasone, paracetamol, dexketoprofen/metamizole, ketamine, magnesium), and tranexamic acid. Multicenter study: Hospital de la Santa Creu i Sant Pau (Barcelona, 32 patients) and Hospital Quirón Salud Murcia (30 patients). Primary outcome: intraoperative blood loss (surgical aspirate minus irrigation + gravimetric gauze weight). Secondary outcomes: Fromme surgical field scale, pain (NRS at REA discharge/24h/48h), opioid consumption (morphine equivalents), PONV/antiemetic use, drain output, hospital stay, patient satisfaction. N=62 patients (31/arm). Blinded outcome assessment.

The objective of this study is to evaluate the effectiveness of a modified continuous renal replacement therapy (CRRT) protocol in maintaining electrolyte balance in adult patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU). The study assesses whether the use of continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under citrate anticoagulation reduces electrolyte losses and the need for electrolyte supplementation compared with standard dialytic CRRT. Participants receiving standard CRRT will be compared with those treated with the modified protocol. The duration of participation corresponds to the period during which CRRT is required. Data collection will cease once CRRT is discontinued.

To evaluate whether a postoperative therapeutic strategy, Fast Track, aimed at shortening hospital stay in pediatric patients undergoing laparoscopic appendectomy for complicated acute appendicitis, yields outcomes that are not inferior to the standard therapeutic model in terms of the combined variable of adverse events within 30 days postoperatively (including postoperative abdominal abscess, peritonitis, surgical wound complications, reintervention, sepsis, or death).

The goal of this observational study is to characterize different subgroups among patients with type 1 diabetes. The main research question is: Are there distinct subtypes among people with type 1 diabetes? Participants will be invited to take part in the study by allowing access to their health data. They will not be required to undergo any additional examinations, tests, visits, or interventions.

Unicentric retrospective study designed to analyses the performance of various machine learning approaches to predict patterns of chronic respiratory diseases such as asthma, based mainly on clinical information and respiratory spirometry/oscillometry.

In pregnancies with placental insufficiency, the only available treatment is close monitoring to determine the point at which the risks of preterm birth for the baby are lower than the risks of continuing the pregnancy. Therefore, safely prolonging pregnancy is the current management goal for this condition. Statins, such as pravastatin, are approved and marketed drugs used to prevent cardiovascular disease. Recent studies suggest that statins may help treat pregnancy complications and prolong pregnancy, thereby avoiding extreme prematurity and improving long-term health outcomes for both mother and baby. Previous clinical trials have shown the ability of statins to stabilize angiogenic factors, thus reducing obstetric complications associated with placental insufficiency. In 2015, a study reported that pravastatin was effective in stabilizing blood pressure and reducing proteinuria associated with preeclampsia. More recently, in 2020, it was demonstrated that in pregnant women with fetal growth restriction treated with pravastatin, the sFlt-1/PlGF ratio was lower than in untreated women, indicating a slower progression of placental insufficiency. This study proposes administering a daily dose of 40 mg of pravastatin between 24 and 29.6 weeks of gestation to mothers diagnosed with preeclampsia and/or fetal growth restriction. One group of women will receive the medication, while another group will receive a visually identical but inactive pill (a placebo), allowing us to determine whether any observed improvement in pregnancy is attributable to the medication. Assignment to the treatment or placebo group will be random, and neither the mothers nor the healthcare professionals caring for them will know which group they are in. The investigators also aim to examine whether this intervention during pregnancy protects the cardiovascular system. For this reason, the investigators will assess both the mother and the baby six months after birth using an ultrasound of the heart and blood vessels, and the investigators will also perform a blood test on the mothers. Additionally, the investigators want to explore the needs and expectations of women who experience these complications during pregnancy and postpartum, so that their stories can guide us in finding answers and solutions that are as personalized as possible to the real needs of families. After the visit at six months postpartum, yhe investigators will follow up with annual phone calls over the next four years to check on the participants' health and their baby's. During each call, the investigators will review the participant's health status and talk about how the participant is feeling. All of this will help us ensure that the treatment does not cause any long-term issues and will improve future care for other mothers and babies. A total of 154 pregnant women are expected to be included in order to meet the study's objectives.

The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS. The main questions it aims to answer are: Does DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming? Does this programming approach improve quality of life and motor symptoms compared with standard programming? Researchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time. Participants will: Undergo DBS surgery using a clinically approved DBS system Be randomly assigned to one of two DBS programming strategies Wear inertial sensors at home for several days at different time points to objectively measure motor symptoms Attend scheduled clinical visits for DBS programming and motor and non-motor assessments Have adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins

The goal of this study is to see if a short educational session and demonstration by a nurse can help asthmatic children (6-17 years-old), under hospital control, to manage their asthma better, to use their inhaler correctly, and to know when it should be used. The main question it aims to answer is how much improvement is reached on asthma self-management. The comparison group is the same group. Researchers will compare results before and after educational intervention.

Mechanical ventilation is an essential, life-saving therapy in the ICU, allowing critically ill patients to rest and recover. Transitioning patients back to spontaneous breathing-known as weaning-is clinically challenging. The first attempt, the Spontaneous Breathing Trial (SBT), fails in 10-30% of cases. Identifying the mechanisms behind failure is crucial, as unsuccessful weaning prolongs ICU stay and increases the risk of reintubation, which worsens prognosis. The SCOUT study aims to improve prediction and management of weaning failure. The main objective of the study is to evaluate whether a specific ultrasound-based method, the Venous Excess Ultrasound Score (VExUS), can predict failure of weaning from mechanical ventilation. A key pathophysiological factor is systemic venous congestion. When a patient initiates an SBT, the increased respiratory effort shifts venous return and may precipitate cardiovascular decompensation with pulmonary fluid accumulation, termed weaning-induced pulmonary edema (WIPO). Notably, this may occur even in patients without known cardiac disease. Detecting clinically relevant congestion before SBT is difficult. Fluid balance and body weight are imprecise, physical examination lacks sensitivity, and biomarkers such as NT-proBNP have limited predictive capacity. VExUS offers a promising, non-invasive approach by directly assessing venous flow patterns in major veins (inferior vena cava, hepatic, portal, and renal veins), providing an estimation of systemic venous pressure and congestion. The central hypothesis is that elevated VExUS grades prior to SBT will identify patients at high risk of failure, enabling proactive optimization and potentially improving outcomes. SCOUT is designed as a prospective, multicenter, observational study. Standard clinical management of mechanical ventilation and weaning remains unchanged. After informed consent, baseline data will be obtained immediately before SBT, including vital signs, ventilator parameters, blood sampling, and three non-invasive ultrasound assessments: cardiac, pulmonary, and VExUS. During the 30-120-minute SBT, the patient breathes with reduced ventilatory support while their clinical tolerance is evaluated. At the end of the SBT, selected measurements are repeated. Weaning failure is defined as: early termination of SBT due to intolerance, need for invasive or non-invasive ventilation within 48 h after extubation, or death within 48 h. Data are anonymized and stored securely (REDCap) in compliance with Spanish and EU data protection regulations. The study is low-risk and provides no direct individual benefit, but may benefit future ICU patients by improving weaning strategies and prognostication.

In this project, the investigators aim to study how all these factors determine the cardiovascular status of a total of 1,800 mothers, 3 to 6 years after delivery. In addition, the investigators want to assess whether lifestyle and living conditions after childbirth may improve or worsen this imprint, since women often prioritize their families over themselves, making it more difficult to maintain a healthy lifestyle that could reduce their cardiovascular risk. Furthermore, the investigators will evaluate how environmental exposures influence their health, as well as explore potential strategies for prediction and prevention. The goal is to develop an easy-to-use algorithm or test that allows women and their physicians to assess this risk, ideally in the form of a mobile app. Although predictive algorithms for cardiovascular health already exist, most have been developed using predominantly male or older populations, and none have taken into account pregnancy-related events or environmental exposure - both of which are key determinants of women's cardiovascular health.

The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease. Patients will be randomly assigned to one of two groups: one group will receive the active drug (levetiracetam), and the other will receive a placebo. Both groups will receive the treatment for 96 weeks. Each patient will participate for a total of 2 years and 5 months.

The goal of this prospective cohort study is to determine the factors that influence the progression of endometriosis and the quality of life of patients. The main questions it aims to answer are: 1. Is endometriosis a progressive disease? 2. Is the progression of lesions visualized by ultrasound dependent on the medical treatment received? 3. Does the clinical progression of patients correlate with the progression of lesions visualized on transvaginal ultrasound? 4. Is ultrasound follow-up necessary for patients? 5. Could clinical follow-up alone be safe for selected patients? Researchers will follow up a prospective cohort of 100 patients diagnosed with deep infiltrating endometriosis (DIE) +/- endometriomas during 2 years, collecting data regarding their ultrasound exam and their symptoms and quality of life at stablished controls at recruitment, 6 months, 12 months and 24 months.

\--- The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are: * Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion? * What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion? * How do genetic polymorphisms affect the efficacy and safety of amiodarone? * How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms? Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety. Participants will: * Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion. * Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day). The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.

The FIRST-CARE Study is a prospective research project conducted at Hospital de la Santa Creu i Sant Pau (Barcelona, Spain), aimed at better understanding the causes and consequences of first-trimester pregnancy loss (miscarriage). Miscarriage is a common event that affects about 15% of clinically recognized pregnancies and can have both physical and emotional consequences for women and their partners. However, many questions about its causes remain unanswered, and most women do not receive a clear explanation or personalized support after experiencing a loss. This study will include 225 women who have experienced a miscarriage during the first 14 weeks of pregnancy. Two groups will be studied: those who have had a miscarriage for the first time and those with a history of recurrent pregnancy loss (defined as two or more previous miscarriages). The aim is to investigate a wide range of possible causes - including genetic, hormonal, immune, cardiovascular, placental, and psychological factors - in order to improve diagnosis and develop more personalized care strategies. Participants will undergo a comprehensive evaluation including ultrasound, blood tests, genetic testing, and psychological assessments. In some cases, their partners will also be invited to participate. Women will be followed for one year to assess their mental well-being and reproductive outcomes, such as the chance of getting pregnant again and the outcome of future pregnancies. The study will also create a biobank of biological samples to support future research in the field of pregnancy loss. By combining clinical evaluations, laboratory tests, and personal experiences, this study aims to uncover new insights into why miscarriages happen and how to better support women and couples going through this experience. The ultimate goal is to provide better diagnostic tools, care pathways, and support systems to reduce the emotional burden of miscarriage and improve reproductive health outcomes.

The objective of this clinical trial is to evaluate the effect of positional restraint on the stress level of preterm newborns, resting in the incubator. The main question sought to be answered is: The stress level of the preterm newborn will decrease with swaddy® containment, compared to standard care, and both with similar safety. Participants will remain in the incubator for 3 consecutive hours and the level of stress in the same patient will be evaluated, one day with containment and another day without containment.

Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections . The main questions the trial aims to answer are: * Which device type better prevents injuries to the urethral meatus? * Which device reduces discomfort for patients? * Which device lowers the incidence of catheter-associated urinary tract infections? Participants will: * Use either an adhesive or an elastic device to secure their urinary catheter during their stay in critical care * Be monitored regularly to assess any injuries, discomfort, or infections related to the catheter * Provide feedback on their comfort and any complications experienced, if they are able to communicate

This doctoral project aims to develop a comprehensive theoretical model of the process through which the suicidal ideation framework is configured as a symbolic, narrative, and relational expression, adopting a multiperspective approach that spans the suicide attempt and the stages of care and recovery. Moving away from biomedical reductionisms, this investigation seeks to identify shared meaning-making nuclei and discursive fractures that reflect the inherent conflictuality of the suicidal act. Grounded in the integration of the theoretical frameworks previously outlined, this study adopts an interpretive-constructivist approach. Phase 1 will include studies conducted in OECD countries, providing a broad and conceptually diverse interpretive foundation. Phase 2, conducted in Catalonia, will deepen situated configurations, assuming that local sociocultural frameworks act as interpretive prisms for globally relevant phenomena. Overall, this theoretical-methodological architecture not only ensures conceptual robustness and coherence, but also articulates an ethical and epistemic commitment to understanding suicide through the complexity of its human textures. By centering suffering, listening to historically silenced voices, honoring the singularity of each life trajectory, and grounding the inquiry in an ethics of care, this study aims to transcend a merely technical-instrumental logic of knowledge.

The goal of this study is to assess the acceptability and satisfaction with the psychological intervention Sentirnos Seguros (Feeling Safe) in people with psychotic disorders and positive delusional symptoms. The main questions it aims to answer are: * Study participants will report high levels of acceptability and satisfaction with the Sentirnos Seguros programme. * The Sentirnos Seguros intervention will be beneficial for participants at a clinical and functional level, with higher scores in the post-treatment phase compared to the pre-treatment phase.