Clinical trials

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of CD19 CAR-T cell therapy (TranspoCART19) in adults with refractory lupus nephritis. Lupus nephritis is a serious kidney complication of systemic lupus erythematosus that may not respond adequately to standard treatments. The main questions this study aims to answer are: * Is TranspoCART19 safe and tolerable in patients with refractory lupus nephritis? * Can TranspoCART19 induce complete or partial clinical and immunological remission? Participants will: * Undergo leukapheresis to collect immune cells for manufacturing TranspoCART19. * Receive lymphodepleting chemotherapy before treatment. * Receive a single fractionated infusion of TranspoCART19. * Attend regular follow-up visits for safety, disease activity, kidney function, immune response, and quality-of-life assessments for up to 24 months, with long-term safety follow-up after study completion.

What is the diagnosis and what treatment is indicated? The diagnosis is eyelid ptosis, which means drooping of the upper eyelid. This may reduce quality of life by affecting the upper visual field and interfering with daily activities such as driving and reading. It may also cause forehead muscle fatigue, neck pain, a sad or tired appearance, eyelid asymmetry, and forehead wrinkles. The only treatment to correct eyelid ptosis is surgery. In the present case, the indicated procedure consists of reinserting the tendon of the upper eyelid levator muscle into the original position on the tarsus. This is performed using sutures to attach the tendon to the tarsus. Two types of sutures may be used: absorbable sutures, which are absorbed by the body over approximately 2-3 months, and non-absorbable sutures, which remain permanently in the eyelid because the body cannot break them down. Why is this study being conducted? The surgery that participants will undergo is part of the standard treatment for eyelid ptosis. Both types of suture material used in this procedure are routinely used in clinical practice, meaning that either type could be used regardless of participation in the study. Some previous studies suggest that non-absorbable sutures may maintain eyelid elevation better in the long term and reduce the need for further surgery compared with absorbable sutures. However, there is currently insufficient evidence to establish this with certainty. Most previous studies have evaluated patients who had already been treated rather than prospectively comparing both types of sutures through a randomized clinical trial, which may introduce bias when interpreting the results. Therefore, there is currently insufficient scientific evidence to determine with certainty which suture material provides better results, and both materials continue to be routinely used in clinical practice. The aim of this study is to compare both types of suture under controlled conditions through a randomized controlled trial, in order to determine the outcomes associated with each type of suture in the medium and long term. How will the type of suture be determined? If a participant agrees to participate, the type of suture used during surgery will be assigned randomly by a computerized randomization system. Neither the participant nor the surgeon will be able to choose the type of suture. Both suture materials are routinely used in clinical practice and are authorized for this type of surgery. The only difference between the two study groups will be the material used to attach the upper eyelid levator tendon to the tarsus. Participants will not be informed which type of suture was used during surgery, although this information may be accessed if medically necessary. What does the procedure involve? The surgery will be performed in an operating room by ophthalmologists specialized in eyelid surgery. The procedure will be performed under local anesthesia with light sedation. This is an outpatient procedure and does not require hospital admission. The procedure lasts approximately 45-60 minutes. If removal of excess skin is required in a particular case, this will be performed during the same procedure. Anterior white-line (levator tendon) advancement through the skin produces a scar within the eyelid crease. This is generally a cosmetic and well-tolerated scar. Five visits will be required for appropriate follow-up, which is the same number of visits that would be required without participation in the study: the initial visit, the day of surgery, and three follow-up visits at 2 weeks, 3 months, and 7 months. Participation in this study does not involve any additional risk from supplementary tests. During the study, photographs of the periocular area and face will be taken to evaluate the surgical outcomes. These images will be treated as personal health data. If a participant decides to participate, the participant will be asked to sign an Informed Consent Form. Participation will involve allowing information from the medical record to be collected, consenting to relevant clinical photographs, and attending the scheduled follow-up visits. The study will be conducted at Hospital Rey Juan Carlos and aims to include 58 patients with the same condition.

The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.

Introduction: Suicide is one of the leading public health issues worldwide. Mobile health can help us to combat suicide through monitoring and treatment. The SmartCrisis 2.0 randomized clinical trial aims to evaluate the effectiveness of a smartphone-based Ecological Momentary Intervention to prevent suicidal thoughts and behaviour. Methods and analysis: The SmartCrisis 2.0 study is a randomized clinical trial with two parallel groups, conducted among patients with a history of suicidal behaviour treated at the University Hospital Fundación Jiménez Díaz. The intervention group will be monitored using Ecological Momentary Assessment and will receive an Ecological Momentary Intervention called 'SmartSafe' in addition to their treatment as usual (TAU). TAU will consist of psychiatric follow-up of the patient (scheduled appointments with a psychiatrist) in our outpatient Suicide Prevention clinic, with predetermined clinical appointments according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months). The control group would receive TAU and be monitored using EMA. Ethics and dissemination: This study has been approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz. It is expected that, in the near future, the mobile applications MEmind and eB2 can be implemented in routine clinical practice. Results will be disseminated through peer-reviewed journals and psychiatric congresses.

Prolonged activated partial thromboplastin time (APTT) is a frequent laboratory finding that may reflect a broad spectrum of underlying conditions, ranging from benign laboratory abnormalities to clinically relevant hemostatic disorders. Clot waveform analysis (CWA), automatically generated during routine APTT testing by optical coagulation analyzers, provides additional quantitative and qualitative information on clot formation dynamics. The APTTO model is a previously developed two-step predictive algorithm based on CWA features designed to estimate the probability of a pathological cause of prolonged APTT and to differentiate lupus anticoagulant from intrinsic pathway factor deficiency or von Willebrand disease. Internal validation has demonstrated good discrimination and calibration. This multicenter observational study aims to perform an external validation of the APTTO model in independent patient cohorts, assessing its discrimination, calibration, and decision-analytic performance without model updating.

This study is testing different blood-thinning treatment strategies for people who have had a heart attack and were successfully treated with a coronary stent procedure (PCI). All strategies tested are already approved for this condition and used inversally. This study will define which of the approved strategies is the best one. After PCI, patients usually receive two antiplatelet medicines for up to 12 months to help prevent another heart attack or stroke, but this treatment can also increase bleeding risk. This study will compare a shorter course of dual antiplatelet therapy followed by one antiplatelet medicine alone versus the standard 12-month course. In addition, the study will compare two commonly used antiplatelet drugs, prasugrel and ticagrelor. The goal is to find out which strategy best prevents death, heart attack, or stroke while minimizing serious bleeding. This study is not testing any new intervention, rather comparing approved drugs and approved durations of use.

The participating researchers register all adult patients (who have given informed written consent) scheduled for elective repair of an abdominal wall hernia (NOT inguinal hernias) via minimally invasive operation technique (i.e.: laparoscopy or robotic repair) and perform a follow up of 5 years to analyze clinical outcome parameters. These parameters include recurrence of the hernia, intra- and postoperative complications, quality of live, esthetic outcome and pain. The patients will be reviewed in person by the participating researchers at 2-3 moths, 1 year, 3 years and 5 years after surgery. A computed tomography will be performed at 1 year after surgery and in case of suspicion of complications, for example hernia recurrence. The treatment and follow-up of the participating patients does not differ from the standard treatment protocol (and the not participating patients).

Primary objective \- To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment Secondary objective(s) * To study biomarkers variation post-treatment in patients with and without Nasal Polyposis * To demonstrate the existence of different subtypes of eosinophils that may be phenotypically and functionally heterogeneous * To increase the number of patients in the cohort on biologic treatment to reach at least 900 (400 over the current cohort).

People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias. With the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence. The ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence. Participants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months. If successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions

The goal of this protocol for an observational retrospective multi-site cohort study is to develop a predictive algorithm for suicidal behavior integrating genetic risk markers, digital phenotypes, and exposomic data in people with a lifetime history of suicide attempt. Participants will be aged from 12 onwards (requiring parental consent if under 18) and only be excluded if they are unable to provide a genetic sample or do not consent to the study. The main question\[s\] it aims to answer is: \- Can genotyping/omics analysis of individuals with a history of suicidal behaviuor reveal potential genetic factors associated with suicide risk? Secondary questions include: 1. Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout? 2. Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record? 3. Do different suicidal phenotypes differ based on the collected variables? 4. Can the investigators construct an exposome using geolocated and time-stamped data from Google Takeout, combined anonymously with data from the National Statistics and Meteorology Institutes? The investigators hypothesize that: 1. Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data). 2. Suicidal phenotypes-especially between single and multiple attempters-will differ across collected variables, including genotype, omics, and exposome data. participants will complete genetic assessments, digital phenotypes, clinical questionnaires and exposomic data

Recent research suggests a significant link between gut microbiota and anastomotic leakage (AL) in colorectal surgery. Patients who develop AL have a higher abundance of bacteria from the Lachnospiraceae family and lower microbial diversity. Considering the bibliographic data, our main interest is to analyze the microbial population of patients in our social environment and then look for differences in the microbiome between those who have suffered an anastomotic dehiscence (around 8-9% according to the results of our hospital's Surgery Department) and those who have not.

The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems. Heart failure continues to be a major cause of hospital admissions and death in our society. Because of this, it is very important for healthcare professionals to identify which patients are at higher risk of complications, so that we can provide the best possible treatment and follow-up. One method we use to help predict how the disease may evolve is the study of biomarkers, which are measurable biological substances that can help detect, monitor, or treat illnesses in a more personalized way. In this study, the investigators will measure mainly inflammatory biomarkers that will be analyzed from a blood sample taken during hospital stay after being diagnosed with heart failure with preserved or mildly reduced ejection fraction. Any important health events that happen during the next six months after patients are discharged from hospital will also be recorded. In addition, it is known that more than 2,000 diseases are known to be caused by changes in specific genes. In the case of cardiomyopathies-heart muscle diseases that can lead to heart failure-genetic causes vary depending on the type, and studies suggest that between 10% and 50% of cases may have a genetic origin. Identifying genetic markers linked to heart failure with preserved or mildly reduced ejection fraction may help improve prevention, treatment, and risk assessment, as some genetic changes may be associated with repeated cardiovascular events. By studying not only circulating biomarkers but also genetic factors, the investigators hope to better understand whether certain gene alterations may increase a person's tendency to experience additional heart-related events. This is an observational study, which means that medical care and treatment will be exactly the same whether patients choose to participate or not. Participation involves allowing researchers to collect relevant information from medical records and agreeing to the collection of two or three small additional blood samples for research purposes. These samples will be used to measure the biomarkers and to analyze genes in the white blood cell fraction obtained from the same tubes.

The goal of this clinical trial is to compare the efficacy of two surgical techniques-anterior and posterior white line advancement-for the correction of primary aponeurotic ptosis in adult patients. The main questions it aims to answer are: Does the anterior approach lead to a greater improvement in Marginal Reflex Distance 1 (MRD1) at 6 months compared to the posterior approach? Are there differences in eyelid symmetry, contour, visual function, and patient satisfaction between the two techniques? Researchers will compare the anterior approach group to the posterior approach group to see if one offers better functional and aesthetic outcomes, fewer complications, or higher patient satisfaction. Participants will: Be randomly assigned to receive either anterior or posterior white line advancement surgery. Undergo preoperative and postoperative evaluations at 7 days, 2 months, and 6 months, including: Measurements of eyelid position (MRD1), contour, and symmetry Vision and tear film tests (e.g., refraction, TBUT, Schirmer's test) Surveys on dry eye symptoms (OSDI), scar quality (POSAS 2.0), satisfaction, and psychosocial function Monitoring of surgical time and complications

The main objective of this study is to evaluate whether digital fetal scalp stimulation improves fetal well-being in fetuses with suspicious or pathological cardiotocographic recordings, showing an improvement in cardiotocographic recording patterns and normal values in intrapartum fetal scalp blood results. Upon detection of a suspicious or pathologic cardiotocographic recording, the investigators need to perform an objective verification of fetal well-being. Currently, fetal scalp blood is the reference test to assess intrapartum fetal hypoxia, according to the protocols of the Spanish Society of Gynecology and Obstetrics. This procedure lasts about 5 minutes and consists of taking a small sample of the fetal scalp, through a vaginal exploration, the blood is collected in a thin tube and analyzed by a machine in the delivery room obtaining the results in a few minutes. The investigators emphasize that this test is not part of the study, as long as the monitor is suspicious or pathological, it will be performed according to protocol to objectively assess fetal well-being. Currently there are studies that support the use of fetal scalp stimulation as an alternative technique to assess intrapartum fetal well-being and predict neonatal outcomes, but they also highlight its limited evidence. Digital fetal scalp stimulation is a NON-invasive method, as no instrument is required and fetal stimulation is a 30-60 second surface rubbing pressure, which is performed manually, through vaginal exploration, the same technique the investigators use to assess dilation during the labor process. Each patient will be randomly assigned to a study group: Experimental group: before the extraction of capillary blood from the fetal scalp, fetal head stimulation will be performed, a technique that poses no risk to the baby. The researchers need the consent of the participants to perform this technique and collect data. Control group: fetal head stimulation will not be applied, but data from the clinical history necessary for this study will be collected. In no case will extraordinary or unnecessary tests be performed for participation in this study. This study will have an Informed Consent document. This study will be carried out at the Fundación Jiménez Díaz and Zarzuela and will include 182 patients for 24 months.

The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve. Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion. Secondary Objectives * To compare pre- and post-treatment pregnancy rates. * To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1 * Patient Selection * Confirm that he/she has all the analyses and variables to be studied. * Signing of Informed Consent * Usual IVF protocol (1st IVF cycle) VISIT 2 * Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3 * Analytical control at 4 weeks VISIT 4 * Analytical control at 8 weeks VISIT 5 * In case of failure to achieve gestation Start of 2nd cycle of IVF

Airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postoperative recovery. The World Health Organization and European initiatives such as the Human Exposome Project have highlighted the clinical importance of the exposome, defined as the totality of environmental exposures influencing health throughout life. EOX is a CE-certified air regeneration system designed to modify the indoor exposome through a dual mechanism: advanced filtration and controlled emission of bioavailable anions using cold atmospheric plasma (CAP). Its multistage filter removes particulate matter, pathogens, and volatile organic compounds, while the anionic plasma phase modulates cellular oxidative balance and metabolic function. Experimental and clinical data indicate that exposure to EOX improves mitochondrial efficiency, increases ATP production, and reduces oxidative protein damage. EOX has also been shown to influence molecular pathways involved in stress adaptation and repair, such as the HIF-1α-VEGF-EPO axis and protein synthesis signaling (e.g., mTOR-p70S6K). These mechanisms may collectively enhance tissue recovery, vascularization, and metabolic resilience in the postoperative setting. The present study investigates the effects of EOX in hospitalized postoperative patients, evaluating both subjective (sleep quality, well-being) and objective (vital signs, metabolomics, microbiota composition) endpoints. The central hypothesis is that EOX induces a beneficial hormetic response-an adaptive reaction to mild environmental stressors-reflected by improved clinical recovery and biomarker modulation (e.g., succinate reduction, increased ATPase activity). The goal is to assess whether EOX can serve as an effective environmental intervention to support physiological healing and improve the quality of inpatient recovery.

Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.

The DEPRECAP (Early detection of lung cancer) study is an ongoing, prospective, longitudinal, multicenter lung cancer screening program that recruited individuals with COPD or emphysema from the pulmonary clinics of Fundación Jiménez Díaz University Hospital and Villalba General Hospital, in Madrid, Spain. The aim of this observational study is to determine the scientific evidence needed to study the benefit and potential effects of lung cancer screening in this group of patients and to determine the long-term effects of the intervention in reducing the high mortality rates associated with late-stage lung cancer diagnosis in a very high-risk population, to address under-diagnosis of COPD and to promote smoking cessation. This leads to the creation of a registry with clinical, radiological, functional data and biological samples for future studies in this cohort of patients to provide the scientific evidence needed to study the benefit and potential effects of screening for lung cancer and other tobacco-related pathologies diagnosed by Low-dose CT (LDCT)

Title: Impact on quality of life and disease burden in adults with herpes zoster Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3. Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.

Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 24. Secondary objective: 1. To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 12. 2. To evaluate the clinical response of enthesitis to upadacitinib by LEI, at week 12 and week 24. 3. To evaluate the clinical response of disease activity by DAPSA, at week 12 and week 24. Study Design: single-arm, observational longitudinal, prospective study Population: The study population will consist of adult patients (aged ≥ 18 years old and ≤ 65 years old) with PsA according to CASPAR classification criteria, who have been prescribed upadacitinib over the course of routine practice, in accordance with the applicable approved label and local regulatory and reimbursement policies ("In patients with psoriatic arthritis, upadacitinib would be a therapeutic alternative after failure, inadequate response or intolerance to csDMARDs and anti-TNF") and have at least one ultrasound-determined peripheral enthesitis.