Seoul(kangbuk), Korea, Republic of
Protocol to Improve the Representation of the Reproductive Process in Spanish Fiction.
Introduction: Since the 1970s, representations of women in fiction have been the subject of interdisciplinary analysis to understand how cultural narratives perpetuate, challenge or transform patriarchal discourses. Researchers such as Friedan, Faludi and Macdonald have shown how the media reproduce myths of femininity that reinforce gender inequalities. According to De Lauretis, gender is constructed through representation, while Ricoeur stresses that cultural narratives shape individual identities by linking personal histories with collective imaginaries. In the area of motherhood, researchers such as Douglas and Michaels, Feasey and Kaplan have shown how the media reinforces conservative ideals such as 'new momism' and simplifies biological processes such as pregnancy and breastfeeding, while personal testimonies reveal tensions between cultural expectations and lived experiences, highlighting the need for more inclusive and diverse narratives. Aim: The project analyzes the representation of reproductive processes-such as menstruation, pregnancy, abortion, and menopause-in contemporary Spanish audiovisual fiction, assessing how these narratives reflect or challenge socio-cultural structures and reconfigure traditional imaginaries. Through an intersectional and interdisciplinary approach, the research team aims to understand how different audiences, particularly those related to reproductive health, perceive these narratives. The study will include an analysis of fiction, the perceptions of users and professionals, and collaboration with organizations such as the Catalan Association of Midwives (ACL) and audiovisual experts to co-produce a good practice guide that promotes inclusive, ethical, and patriarchy-free representations. Material and method: The study will follow a sequential transformative mixed method design (DITRAS), with qualitative predominance and participatory action research, divided into three phases. In the first phase, a quantitative approach will be used with a descriptive cross-sectional study, based on a systematic search of film databases, digital platforms and on-demand television. In the second phase, users' and professionals' perceptions of reproductive health processes will be explored through focus groups and interviews. In the third phase, participatory action research will be applied to co-create a manual of good practices to be implemented in undergraduate and postgraduate training in communication and journalism. Discussion: To our knowledge, this is the first study to analyze the representation of reproductive processes in Spanish fiction. According to Goffman, the way messages are framed in the media influences the audience's perception of problems and their solutions, leading to psychological, social, and political repercussions. Through strategically designed narratives, the media has the power to shape attitudes and drive social change, as highlighted by the WHO in its guidelines for addressing sensitive issues such as suicide. Previous studies on the portrayal of childbirth suggest that fiction has distorted the perception of care quality, overrepresented white, heterosexual, non-disabled couples, and depicted women as passive participants in the process. The findings of this study have the potential to enhance the representation of reproductive processes in the media, fostering a more inclusive and accurate perspective that could shape public perceptions and contribute to the development of more equitable policies.
Phase
N/ASpan
92 weeksSponsor
Universitat de LleidaLleida
Recruiting
Healthy Volunteers
PuraStat® Combined With Adrenaline Versus Standard of Care in Upper Gastrointestinal Bleeding
Endoscopic treatment serves as the first-line approach in managing upper gastrointestinal bleeding (UGIB), demonstrating effectiveness in reducing re-bleeding rates, the need for surgical intervention, and mortality. In non-variceal UGIB, endoscopic management includes various techniques such as injection therapy, thermal therapy, mechanical therapy, or a combination, depending on the lesion type. However, certain factors, including the anatomical location of the lesion, underlying fibrosis, or diffuse bleeding, can present challenges to successful treatment. Haemostatic powders have been increasingly utilized as both primary and salvage therapy for bleeding control in various clinical scenarios, including post-polypectomy bleeding, bleeding associated with colonic tumors, diverticula, arteriovenous malformations, radiation proctitis, ischemic colitis, and surgical intestinal anastomoses. Their use in UGIB management has also expanded. Compared to other modalities, these topical agents offer advantages such as ease of application, the ability to reach lesions in challenging locations, and coverage of larger surface areas without requiring precise targeting. Among the most extensively studied topical hemostatic agents are TC-325 (Hemospray®, Cook Medical), the Polysaccharide Hemostatic System (Endoclot® PHS), and Inha University-Endoscopic Wound Dressing (UI-EWD) (NextBiomedical Co., Incheon, South Korea). These agents have demonstrated high rates of immediate haemostasis (86%-100%) when used alone or in combination with other haemostatic methods, exhibiting excellent feasibility and a favorable safety profile. The primary limitation of these agents is their adherence exclusively to actively bleeding sites, leading to rapid washout within 12-24 hours, thereby making them a temporary measure. Additionally, their opacity obscures the underlying mucosa after application, preventing further visualization of the lesion during the procedure. Further studies are required to better define the role of hemostatic powders, establish optimal use settings, and evaluate long-term efficacy and safety in bleeding control. PuraStat® is a novel gel that provides several advantages over traditional hemostatic powders. Its transparency allows for continuous visualization of the bleeding site, and it can be applied in narrow spaces or in combination with other treatments. The pre-filled syringe design facilitates ease of handling and precise delivery. To date, most published data on PuraStat® as a haemostatic agent originates from surgical settings. In endoscopy, its primary applications have been in polypectomy-related haemostasis and the promotion of wound healing. Reports indicate a haemostasis success rate of 90.4%, with a recurrence rate of 10.4%. However, data on its efficacy in UGIB lesions remain limited. This study hypothesizes that PuraStat®, when combined with Adrenaline, represents a feasible and effective first-line treatment for gastrointestinal bleeding, potentially matching or surpassing the current standard of care. A prospective, randomized, parallel-group, open-label clinical trial is proposed. During endoscopy, patients requiring treatment will be randomly assigned to one of two groups: standard care or Adrenaline injection combined with PuraStat®. If haemostasis is not achieved with the initial treatment, the alternative approach will be applied. Patients will be monitored for 30 days to assess bleeding recurrence. The study aims to enroll 126 patients (63 per group).
Phase
N/ASpan
109 weeksSponsor
Tallaght University HospitalLleida
Recruiting
Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well
Phase I (month-M1-3): Prepare and submit protocol to Ethics Committee, conduct an updated review of the on eHealth solutions to manage UI using BCTs (e.g. training, education) that have been designed or tested in older adults, and establish contact with the Lithuanian, Spanish and UK participating institutions. Phase1 is dedicated to the management of the project throughout its duration. Phase II (M2-5): Consultation with 4-6 experts on Badder Health (BH) and/or behavioral interventions. Develop a first iteration of the eHealth method and module. Conduct an initial online focus group with 10-12 co-creators of UK to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation). Develop a first iteration of the eHealth method and module (concept development) - by Reason Digital (tech company in Manchester) Phase III (M6-14): Organize, conduct and analyze 5 more focus group (2 in Lithuania, 1 UK and 2 Spain) with 10-12 co-creators each (community-dwelling people aged 50+ of both genders with different physical conditions and UI, health professionals and stakeholders with different backgrounds) to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation). Secondment in University of Manchester. Phase IV (M14-M20): Further develop the eHealth module (concept development) - by Reason Digital (tech company in Manchester) Phase V (M21-36): Multicenter two-armed feasibility RCT study with at least 120 participants (WP3). Participants will be randomized to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group. Phase VI: Early and open communication and dissemination (WP4). Analysis of results.
Phase
N/ASpan
184 weeksSponsor
University of Vic - Central University of CataloniaLleida
Recruiting
Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients
Introduction: Midline catheters (MLC) and peripherally inserted central catheters (PICC) are commonly used vascular access devices (VAD) in healthcare institutions where infusion therapies are required, and have been proven to have an optimal level of safety and efficacy for intravenous drug delivery. However, the insertion of these VADs has a number of potential associated complications (immediate, early and/or late), and proper fixation may reduce them. Hypothesis: Using a universal zinc oxide adhesive securement device (ASD) reduces the number of fixation-associated complications in MLC and PICC compared to a universal ASD with silicone adhesive. Objective: To evaluate the efficacy of using a universal ASD with zinc oxide for post insertion fixation of MLC and PICC in hospitalised adult patients. Methodology: Randomised clinical study. Two randomised groups will be created before catheter cannulation. The control group will be cured with an ASD with silicone adhesiv(Grip-Lok® Ref.3300MWA) and the intervention group will be cured with ASD with zinc oxide (Grip-Lok® Ref.2200NUZA). Expected results: The investigators expect to reduce the number of complications related to the attachment of PICCs and MLCs in adult hospitalised patients following the protocolised placement of a ASD with zinc oxide during the first cure. Specifically, it is expected to reduce the number of catheter dislodgements, the number of medical adhesive-related skin injuries (MARSI) and the amount of phlebitis. Clinical implication: The study will help to improve decision making related to maintenance and care of VAD in order to reduce the main associated complications.
Phase
N/ASpan
48 weeksSponsor
Hospital Arnau de VilanovaLleida, Catalonia
Recruiting
Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry
The S-SAPT SECURE-LAMBRE REGISTRY is a prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF, with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT. 234 patients will be enrolled in the study. The study will be conducted at about 20 investigational centers in Spain. The enrollment phase is expected to take approximately 18 months. Patients included in the study will be clinically followed for 12 months. In addition patients will have imaging (TEE or cCT) follow-up at 45-90 days and 12 month. The hypothesis of the study is the following: After successful procedure of implantation of the Lifetech LAmbre Left Atrial Appendage Closure (LAAC) device in patients with nonvalvular paroxysmal, persistent, or permanent Atrial Fibrillation (AF), a short-term single antiplatelet therapeutic regime of Acetylsalicylic acid (ASA) 100 mg (or clopidogrel 75 mg if ASA contraindication), once daily, for 3 months is safe and effective at 12 months follow-up. Objectives: Primary objective. To evaluate the occurrence of stroke and thromboembolic events at 12 months with short-term SAPT with ASA 100 mg (or clopidogrel 75 mg if ASA contraindication) once daily during 3 months after successful LAAC with the LAmbre device. Secondary objective. To evaluate the occurrence of major bleeding events at 12 months with short-term SAPT with ASA 100 mg (or clopidogrel 75 mg if ASA contraindication) during 3 months after successful LAAC with the LAmbre device. Endpoints: Primary endpoint. A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism at 12 months. Secondary endpoints. 1. Device thrombosis at 45-90 days, if suggested by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (cCT) scan. 2. Device thrombosis at 1 year, if suggested by TEE, confirmed by a CT scan. 3. Cardiovascular death at 12 months. 4. Nonprocedural major bleeding events (Bleeding Research Academy Consortium [BARC] ≥3b) at 12 months. 5. The composite of cardiovascular death, stroke, systemic embolism, and nonprocedural bleeding at 12 months. 6. All-cause death at 12 months. This study has an steering Committee, an independent Data and Safety Monitoring Board (DSMB) and independent Clinical Events Committee (CEC).
Phase
N/ASpan
156 weeksSponsor
Fundación EPICLleida
Recruiting
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
Phase
3Span
115 weeksSponsor
Novo Nordisk A/SLleida
Recruiting
Personalised Medicine in the Identification of Preclinical Cognitive Impairment. Development of a Predictive Risk Model
The "Comprehensive Plan for Alzheimer's and other Dementias" shows that more than 50% of cases of cognitive impairment (CI) in population-based studies are undetected. The figure is particularly striking in the case of mild dementias, of which up to 90% are undiagnosed. The aim is to use the combined power of the integration of clinical, molecular, proteomic, genomic, care, social, environmental and behavioural data in patients, using advanced artificial intelligence techniques for data processing and analysis, in order to generate predictive models for the preclinical detection of CI in the population aged 55-70 years. Multicentre, non-interventional, convergent mixed methods observational study, with a prospective observational design part and a qualitative design part. Sample recruited randomly among users of the public health system in the participating geographical locations. Data will be collected in 6 regions (Andalucia, Castilla-Mancha, Catalonia, Valencia, Madrid and the Basque Country) and their rural and urban Primary Care (PC) networks. Non-institutionalised subjects, aged between 55 and 70 years, assigned to PC centres in the territories included in the study, with a "living history" (recorded in the last 12 months) and without an established diagnosis of CI. A descriptive analysis of the characteristics of the population will be carried out using frequencies and percentages or measures of central tendency and dispersion, with their 95% confidence intervals. Baseline socio-demographic and clinical characteristics will be compared in order to study the homogeneity of the sample. For the comparison of qualitative variables, the Chi-square test or Fisher's exact test will be used and for the comparison of quantitative variables, the t-test or Wilcoxon test will be used. Logistic regression models are proposed to analyse health outcome factors associated with mild cognitive impairment. All models will include repeated measures for each individual. All models will adjust for different risk factors, and for those factors that may change over time, the interaction between time and that factor will be studied. Initially, multivariate linear latent models will be used for the predictive model of cognitive impairment risk. The integration of data from multiple sources of information will be done using multivariate probabilistic models, in order to find a representation of the patient in a feature space influenced by all data sources (visits). Web tools such as Ingenuity Pathway Analysis will allow the integration of data at different molecular levels (genetic, protein and autoantibody), while artificial intelligence tools will allow the integration of such data, data derived from electrochemical sensors and data related to clinical and behavioural data with cognitive impairment in order to obtain a predictive model of cognitive impairment, neurodegeneration and AD.
Phase
N/ASpan
92 weeksSponsor
Instituto de Salud Carlos IIILleida
Recruiting
Distal Radial Access for Coronary Procedures
Introduction In recent decades, trans radial access (TRA) through the proximal radial artery has become the standard access site for performing diagnostic and therapeutic coronary procedures, its advantages over trans femoral access being demonstrated through multiple studies. such as reduction in access site complications and even reduction in mortality, especially in higher-risk patients. There are circumstances in which anatomical variants can limit the clinical benefits of TRA, generating complications such as radial artery occlusion (RAO), which is by far the most frequent complication of this access, with a higher incidence at 24 h and recanalization after 30 days in 50% of patients. The presence of RAO limits access to future procedures, if necessary. The incidence of RAO reported in experienced centers remains high. Distal Radial Access (DRA) through the anatomical snuffbox of the hand is a technique that has emerged in recent years and has been consolidated in multiple multicenter studies and meta-analyses to obtain arterial access in patients undergoing coronary angiography. and coronary intervention, which reduces the incidence of RAO, in addition to reducing hemostasis times, favoring patient and operator comfort compared to TRA. DRA requires a slightly higher learning curve than TRA due to certain anatomical characteristics, such as the size of the distal radial artery, its depth, the presence of tortuosities, and the specific anatomical structures surrounding it. The DRA technique initially described was based on anatomical references (conventional puncture), however, the introduction of ultrasound as a puncture tool allows the operator to identify the size and course of the artery, in addition to a better assessment of the anatomy of the artery. area, thus avoiding injuries to them. Most of the registries and clinical trials conducted to date are single centers, so the conduct of collaborative studies is of interest to determine the usefulness of different types of arterial access in coronary procedures. OBJECTIVES Compare the clinical and procedural characteristics of patients undergoing diagnostic or therapeutic coronary procedures using DRA. PRIMARY OBJECTIVE 1. Determine the success rate of DRA and measure the incidence of RAO. SECONDARY OBJECTIVES 1. Compare the clinical (such as sex, age, weight, etc.) and anatomical characteristics (size of the proximal and distal radial artery size, depth of the distal radial artery) of patients with DRA. 2. Compare the time spent obtaining arterial access using DRA. 3. Assess the characteristics of the DRA procedure. 4. Assess the usefulness of ultrasound evaluation of the radial artery prior to DRA and US-guided DRA. 5. Investigate the predictors of failure for DRA. 6. Calculate the incidence of local complications related to DRA, radial spasm, puncture site hematoma, RAO, and presence of pseudoaneurysm of the radial artery. 7. Assess the operator's and patient comfort based on access. STUDY DESIGN Prospective cohort of patients undergoing diagnostic or therapeutic coronary intervention, performed at the University Hospital Arnau de Vilanova in Lleida and open to other centers.
Phase
N/ASpan
283 weeksSponsor
Hospital Arnau de VilanovaLleida
Recruiting
Dog-Assisted Therapy in Children During Blood or Dental Extraction.
INTRODUCTION: Venous puncture for routine blood sampling can be distressing for many children, leading to heightened anxiety both before and during the procedure. Dental anxiety affects around 9% of European children and adolescents, potentially persisting into adulthood and resulting in dental avoidance behaviors. Animal-assisted therapy (AAT) is viewed as a distraction technique that could play a vital role in managing pain and distress for children. AAT is a planned, structured therapeutic intervention with specific goals, facilitated by healthcare professionals. OBJECTIVES: Evaluate the efficacy of AAT during blood or dental extraction in a Primary Care Pediatric Service. Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals. Estimate the reduction in the child's emotional stress during these procedures with the support of a therapy dog. Evaluate the emotional stress in the accompanying family member. METHODOLOGY: Randomized two-arm clinical trial (control group and intervention group) involving children aged 3 to 8 requiring blood analysis or dental extraction in a Primary Health Care Center. Patients will be randomly assigned to the control and intervention groups. Sample size calculations suggest 60 patients in each group to detect statistically significant differences. The control group follows standard protocols, while the intervention group includes AAT with 10 minutes of pre-procedure interaction with the therapy dog, extraction performed with the therapy dog, and 5 minutes of post-procedure interaction. Personnel includes nurses or dentists, a pediatrician, and an AAT technician. Response variables include various scales measuring anxiety and distress, while control variables encompass age, gender, pathologies, extraction type, and pet ownership. EXPECTED RESULTS: The implementation of AAT as an emotional support intervention, utilizing a therapy dog for distraction, is anticipated to improve symptomatology in the intervention group by reducing fear and anxiety post-procedure.
Phase
N/ASpan
183 weeksSponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaLleida
Recruiting
Effects of Table Tennis for People With Parkinson's Disease
Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games). Interventions in both groups will take place twice a week for 6 weeks (12 sessions in total). The main variables to be assessed will be motor and cognitive. As secondary variables, clinical and daily life aspects will be assessed. As results, it is expected that the experimental group will obtain improvements in motor variables compared to the control group after receiving the interventions. However, improvements in cognitive variables and secondary variables are expected to be similar in both groups.
Phase
N/ASpan
144 weeksSponsor
Universitat de LleidaLleida
Recruiting