Clinical trials

Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress. However, structured postnatal debriefing is not routinely implemented in clinical practice, and evidence regarding its effectiveness remains limited. This study aims to evaluate the effect of a structured postnatal debriefing conducted within the first 24 hours after childbirth in women who have experienced an adverse or unexpected obstetric event. This quasi-experimental pretest-posttest study will include two consecutive groups: a control group receiving usual postpartum care during the pre-implementation phase and an intervention group receiving structured postnatal debriefing during the implementation phase. The primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, satisfaction with information and emotional support received after childbirth, and clinical maternal and neonatal outcomes. This study will provide evidence on whether structured postnatal debriefing improves psychological outcomes and contributes to more patient-centered obstetric care.

The goal of this observational study is to learn more about people who come to emergency departments in Spain after a suicide attempt and to find ways to prevent another attempt. The main questions are whether some personal, social, biological, and clinical factors are linked to a higher risk of trying again, and whether different follow-up strategies can help lower this risk over time. Researchers will follow a total of about 3,600 people who attempted suicide: around 1,800 who were already recruited in a previous study and about 1,800 new participants who will be added in this project, in several hospitals across Spain. Some participants may also be invited to give blood samples, answer online questionnaires, or use smartphone-based tools to understand better changes in mood and suicidal thoughts in daily life. A subset of participants may be invited to join separate clinical trials that test different follow-up programs to prevent another suicide attempt; these trials will be registered and described in their own study records.

Zinc is an essential micronutrient crucial for the normal functioning of the human immune system. Zinc deficiency impairs immune function and increases infection risk, especially in vulnerable populations like people living with HIV. This project aims to study the role of zinc supplementation in improving immune response in HIV-infected individuals who are Immunological Non-Responders (INRs)-people who have not restored Cluster of differentiation 4 (CD4) T-cell counts despite receiving antiretroviral therapy (ART). INRs face a higher risk of opportunistic infections, non-HIV comorbidities due to high inflammation, and generally have a poorer prognosis. Zinc supports immune function by aiding in immune cell development, cytokine production, and maintaining mucosal barrier integrity. Several studies have investigated zinc supplementation in HIV-infected individuals, showing significant increases in CD4 counts and a reduction in opportunistic infections. However, the doses used vary, and the results are sometimes contradictory. Our objective is to study whether zinc supplementation in INRs improves immune function, specifically by increasing CD4 counts, decreasing inflammation, and affecting other immune parameters. This project involves a clinical trial where INRs will be randomly assigned to receive 75mg of elemental zinc daily (in the form of 3 zinc acetate tablets) along with their usual treatment or to continue their treatment without zinc supplements. We will assess whether zinc supplementation increases CD4 lymphocytes, reduces inflammation in INRs, and induces immune system changes. We will also investigate immune system functionality by measuring the presence of the Torque Teno Virus (TTV), a harmless virus, and see how zinc supplementation impacts its control by monitoring viral load changes. Recent research by our group has demonstrated that zinc has both antiviral and anti-inflammatory effects. Zinc supplementation is generally safe and well-tolerated, with few adverse effects. Zinc is available in various forms, including gluconate, acetate, and sulfate. Although the recommended daily dose is 40mg, studies have shown that doses exceeding 80mg have been safely administered for over 10 years without side effects. We have selected a 75mg daily dose of elemental zinc for several reasons. Studies that showed no effect used lower doses (15-20mg/day), and our research found that 75mg/day improved outcomes in acute viral infections like Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV2). We believe previous failures to show zinc's efficacy were due to insufficient dosing. After extensive literature review, we concluded that 75mg daily is safe and likely to produce the desired effects. Our goal is to demonstrate the efficacy of zinc as an immunomodulatory agent. If successful, this could be a simple and cost-effective way to improve the quality of life for many people. We would recommend its widespread use under medical supervision, particularly at the doses being studied.

The main objective of this study is the translation, linguistic adaptation into Spanish, and validation of the Korean quality of life questionnaire KOQUSS-40. This tool will allow us to objectively measure the quality of life of patients in clinical trials.

The goal of this observational study is to determine if rehabilitation program intensity impacts functional recovery and specific needs in adult ischemic stroke patients who require inpatient rehabilitation. The main questions it aims to answer are: Do patients with stroke of Atrial-related subtypes (AFRS) have distinct rehabilitation needs and functional outcomes compared to non-AFRS patients? Does higher-intensity inpatient rehabilitation (3-5 sessions/day) result in better functional recovery at six months (measured by the Barthel Index) than moderate-intensity programs (1 session/day)? The study is non-invasive, does not interfere with usual care. The investigators' ultimate goal is to enhance the understanding of recovery after following different rehabilitation usual programs.

This is a phase III, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. It will be performed involving 630 eyes from patients with wet age-related macular degeneration (wAMD) diagnosis without another eye disease. This clinical trial compares the treatment response for 3 years, considering genetic variants already studied between the eyes treated with one of the first options of anti-VEGF used in patients with wAMD, (ranibizumab) and the most cost-effective anti-VEGF (bevacizumab; off-label use)

The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.

BACKGROUND: Applications for mobile devices in patients with obesity offer a great opportunity to improve the quality of care and the monitoring of patients in bariatric surgery programs. This is especially pressing in the context of an increasing prevalence of obesity, and longer waiting lists in bariatric surgery programs. OBJECTIVES: The main objective is to evaluate the efficacy of a digital platform on mobile devices in obesity and bariatric surgery programs. Investigators will compare weight loss at 12 months after surgery in patients in the standard of care program and those in a semi-attendance program with digital support through a mobile application. As secondary objectives, it will be compared: (1) the number medical complications, the quality of life and satisfaction, physical activity, diet and attrition at 12 months after surgery. Investigators will also study the patient interaction with the platform and social networks. TRIAL DESIGN: Randomized, non-inferiority clinical trial with a 12-month follow-up. METHODS: 72 patients will be randomized (1: 1) to standard of care program and to semi-attendance program with digital support from the bariatric surgery program waiting list. Inclusion criteria: age between 18 and 60 years, body mass index between 35-50kg/m2, candidates for the sleeve gastrectomy technique, and possession of a mobile device. Participants will be evaluated before and 12 months after surgery. Variables: anthropometric measurements, medical complications during follow-up, quality of life, diet and physical activity questionnaires. Primary endpoint: weight loss 12 months after surgery.

This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.

Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 96 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.

It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).

The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures. A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications. The questions we want to try to answer are: * Prevalence and severity of fragility in digestive endoscopy. * Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.

Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose. The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.

Background Frailty has become a major problem for the health system, but also a window of opportunity to fight against disability through preventive strategies focused on the detection and treatment of frailty in all settings. However, no systematic strategies of screening and early detection are available in clinical settings. This project aims to identify clinical and biological phenotypic clusters that drive through the different stages of frailty and to describe the underlying mechanisms of the trajectories leading to disability and the potential for treatment. Moreover, validation of Frailty Trait Scale 5 (FTS5) will be performed as an easy model to be implemented in primary care and hospital scope. Methods/design A prospective population-based cohort will be stablished for frailty phenotyping (CohorFES). Creation of a CIBERFES Biobank where blood and urine samples from participants of CohortFES are stored for future researches. Demographic and clinical history data, anthropometric measurements, predimed questionnaire, peripheral blood biochemical variables and metabolomics were collected for each participant at baseline and every year until become frailty. Using cluster partition models (k-means and hierarchical clustering) will group together individuals with similar deficits and characteristics (frailty phenotypes). Then, by using pre-established criteria (gap and silhouette), the proposed clustering solution (belonging to given clusters) will be evaluated. Further, investigators will assess, in a longitudinal fashion, the appearance and accumulation of deficits during the study period and identifying the clusters subgroups with more rapid progression. Results will be applied to establish and compare clusters and trajectories. Finally, frailty phenotypes and patient clusters will be correlated with health outcomes such as the use of health services (both primary and secondary care), hospital admissions, and mortality. Discussion Information about clinical and biological phenotypic clusters that drive through the different stages of frailty can lead to identify potential targets that could improve the therapeutic management of these patients. In summary, from a research perspective the project aims to better understanding of the interindividual variability in clinical events that lead to frailty, dependence and finally, to death.

Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial). Criteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.

Endocrine therapy is the mainstay of adjuvant therapy in premenopausal women with hormone receptive-positive (HR+) breast cancer as it has been demonstrated that it reduces long-term recurrences and increases survivial. However, this therapy, which suppresses estrogen production and estrogen-induced effects, is associated with the development of joint pain which can significantly reduce quality of life and lead to treatment discontinuation. The main question the study aims o answer is: Can balneotherapy (BT) alleviate muscle-skeletal pain (primary objective) derived from endocrine therapy and improve quality of life (secondary objective) in young women with HR+ breast cancer?

This study (VIHMET) aims to explore how dietary changes, specifically the adoption of a Mediterranean diet, can improve health outcomes in people living with HIV (PLWH) who are on antiretroviral therapy (ART). PLWH often experience chronic inflammation, metabolic disturbances, and elevated cardiovascular risk due to the virus, immune activation, and ART-related side effects. By examining dietary interventions, this study seeks strategies to reduce these risks and enhance quality of life. The VIHMET study is a randomized clinical trial involving 64 participants at Hospital del Mar, Barcelona, randomized into control and intervention groups (1:2 ratio). The intervention group will receive personalized nutritional counseling to improve adherence to the Mediterranean diet, focusing on food selection and meal preparation. The control group will follow standard dietary recommendations. Assessments will occur at baseline, week 24, and week 48. Key health indicators include lipid profiles, markers of inflammation, immune activation, and cardiovascular health, assessed through non-invasive techniques like arterial stiffness and subclinical atherosclerosis measurements. Participants will complete questionnaires on diet adherence, physical activity, and quality of life, alongside anthropometric evaluations. Eligible participants are adults with HIV, undetectable viral loads for 12+ months, and elevated LDL cholesterol with low Mediterranean diet adherence. Exclusion criteria include lipid-lowering drugs, chronic anti-inflammatory therapy, or other active inflammatory/metabolic conditions. This study aims to improve lipid levels, reduce inflammation, decrease arterial stiffness, and assess diet adherence's impact on quality of life and subclinical atherosclerosis. Results may inform dietary recommendations to reduce cardiovascular risks and enhance holistic care for PLWH.

The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are: * Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8? * Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score? In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score Participants will receive either: * the TPS treatment * a sham TPS treatment

Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.

There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation. Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management. Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain. Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery. Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment). Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480). Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health.

Background. Pulmonary arterial hypertension (PAH) is a heterogeneous pathophysiological condition characterized by progressive pulmonary vascular narrowing that ultimately results in right-sided heart failure and eventually death or lung transplantation. The effectiveness of current pharmacological treatments is suboptimal and a large proportion of patients still had events or died despite receiving combination therapy. Vitamin D deficiency has been found to be much more frequent in PAH patients than in the general population or even compared to patients with other severe cardiovascular diseases. Moreover, vitamin D deficiency has a negative prognostic impact in PAH. Animal studies support that vitamin D deficiency worsens PAH. Hypothesis. In patients with PAH and vitamin D deficiency, restoration of vitamin D status with calcifediol improves their symptomatology and prognosis. Design: Multicenter clinical trial with the participation of 9 hospitals, placebo-controlled, randomized (1:1 ratio), in two parallel groups (without crossover), triple blind, and add-on on existing treatments (add-on). It will include at least 102 subjects (51 in the calcifediol group and 51 in the placebo group) followed for 24 weeks of treatment. Inclusion criteria: Patients of both sexes (18-75 years) with hemodynamic diagnosis of PAH and severe vitamin D deficiency (25-OHvitD \<= 12 ng/ml) and without previous diagnosis of osteoporosis or osteomalacia. Treatments: 1) Calcifediol Hydroferol® 0.266 mg once every 10 days for the first 12 weeks and once every two weeks for the following 12 weeks. 2) Placebo. Main objective: A composite endpoint of clinical improvement without clinical worsening at week 24. Expected outcome: Restoration of vitamin D status is an unexpensive measure, very easily implantable and that could improve the evolution of the disease as well as other aspects such as bone or immune health and that has few side effects.