[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,81,108,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100580301","decide-just-culture-conceptualization-of-clinical-error-100580301",false,"NCT06835517","DECIDE Just Culture: Conceptualization of Clinical Error","Design of Tools to Transform the Conceptualization of Clinical Error Within and Outside Healthcare Centers, Social-health Centers, Hospitals and Healthcare Management","DECIDE","Phase 1\n\n* Inclusion criteria: Over 18 years of age, health professionals in primary care, hospitals or social-health centers with more than 5 years of experience. Healthcare managers. People who exercise social leadership in associations, media, blogs, etc. Subjects who voluntarily agree to participate after informed consent and who commit to a dedication of 5 hours.\n* Exclusion criteria: Experience in patient safety groups\u002Fcommittees. Ongoing or serious adverse event claims or litigation with institutions.\n\nPhase 2\n\n* Inclusion criteria: Managers of health centers, hospitals or socio-health centers in Andalusia, Aragon, Valencia and Madrid, with a minimum of 7 years of experience, who agree to participate.\n* Exclusion criteria:Litigation or claim in the last 15 years.\n\nPhase 3\n\n* Inclusion criteria: Same as in phase 1, who voluntarily agree to participate and commit to a dedication of 90 minutes.\n* Exclusion criteria: Same as in phase 1. Who have participated in phase 1.\n\nPhase 4\n\n\\- Inclusion criteria: Male\u002Ffemale balance, minimum 10 years of experience. Recruitment, among members of SEDISA, SEMERGEN, SEMFyC, FAECAP and other scientific societies.",true,"ALL","18 Years",{"count":21,"type":22},1255,"ESTIMATED","INTERVENTIONAL",[25],"NA","The main objective of this project is to extend the principles of Just Culture in primary care, hospitals and social-health centers, providing new information on key elements in the social and professional conceptualization of the human factor (fallibility) in safety incidents.\n\nA mixed design combining cross-sectional observational studies based on qualitative (focus groups and consensus conference) and quantitative (survey) methodology with an experimental study or randomized clinical trial with three arms will be used.\n\nThe methodology is deployed in four stages or phases of the study:\n\n1. Focus Group technique (qualitative research) with 70 primary care health professionals, 80 hospital health professionals, 70 health professionals from socio-health centers, 72 health managers and 80 social leaders to identify key elements of the subjective norms and social influence processes that define the conceptualization of a clinical error, including impact of gender bias and other stereotypes in relation to blame.\n2. Online survey of a stratified random sample of 1,255 managers, middle managers and professionals from primary care, hospitals and social-health centers to analyze the barriers and facilitating factors for the implementation of Just Culture.\n3. Randomized experimental study with three arms (84 subjects in each) and control group to determine the effectiveness of two interventions aimed at modifying attitudes, beliefs and behaviors in relation to honest mistakes, based on the Theory of Dissonance and Reasoned Action, both in social leaders and professionals.\n4. Application of AGREE II and Consensus Conference technique (33 experts) to elaborate a guide of recommendations in order to implement Just Culture in primary care, with the involvement of all actors (social and professional level) that will be transferred to practice.",[28],"Error Disclosure",[30,31,32],"Just Culture","clinical error","honest mistake","RECRUITING","2026-04-28",{"date":36,"type":37},"2026-04-29","ACTUAL",{"date":39,"type":37},"2025-01-23",{"date":41,"type":22},"2027-12",{"name":43,"class":44},"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100623062","early-phase-1-efficacy-of-a-polyhexanide-biguanide-based-gel-in-the-prevention-of-biofilm-formation-in-pressure-ulcers-100623062","NCT07391748","Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers","EGELPUPP","Inclusion Criteria:\n\n* Bedridden patients, patients with bed-to-chair mobility, or those in a wheelchair.\n* Presenting one or more category II-III pressure ulcers.\n* Aged over 65 years.\n* Patients with laboratory results within normal metabolic values (HbA1c \\\u003C 7%).\n* Patients who, in item 6 \"infection\u002Fsuspected biofilm\" of the RESVECH 2.0 index, do not have tissue compatible with biofilm, hypergranulation, or purulent exudate, and never score more than 4 in the other items.\n* During follow-up, cases that develop signs and symptoms of local infection according to TILI and\u002For the RESVECH 2.0 index will be considered therapeutic failures, allowing for clinical rescue, but the patient will remain in the intention-to-treat (ITT) analysis.\n\nExclusion Criteria:\n\n* Patients who, despite the above, present a deteriorated health status that could influence the outcome, such as terminally ill patients, oncology patients, or those with inflammatory diseases.\n* Patients in a state of malnutrition according to the Mini Nutritional Assessment (MNA®) scale who are not receiving nutritional supplements, and\u002For at risk of malnutrition with nutritional deficits.\n* Patients with pressure ulcers in the perineal area and urinary incontinence (except those with a urinary catheter) and\u002For fecal incontinence.","65 Years",{"count":55,"type":22},140,[57],"EARLY_PHASE1","INTRODUCTION: Pressure ulcers (PU) are one of the main challenges for nursing in our country. Wound bed preparation and the TIME algorithm provide essential tools for adequately treating these lesions. However, these wounds tend to become chronic due to the bacterial load in their bed. It is now known that bacteria can form complex and diverse structures, named as biofilm, which are difficult to diagnose and much more resistant to antimicrobial action.\n\nControlling these biofilms is crucial to create the optimal conditions for wound healing. Currently, it is believed that biofilms are present in 60-100% of chronic wounds. Therefore, more studies are needed to evaluate the efficacy of different antimicrobial agents on these structures.\n\nOBJECTIVE: To determine the efficacy of a gel containing polyhexanide and biguanide, alone or in combination with alginate with or without silver, in preventing biofilm in PU, in terms of healing at 4 weeks.\n\nMETHODOLOGY: Multicenter clinical trial with a 2x2 factorial design, conducted with patients from Alcoy with category II and III PUs that meet the inclusion and exclusion criteria. A sample of 140 participants is estimated, distributed into four groups of 35 patients. The interventions that will be carried out will be: application of Prontosan gel® and Aquacel Ag+®; Aquacel Ag+®; control group; Prontosan gel®. Data on wound evolution will be collected using RESVECH 2.0. Descriptive statistical analysis and hypothesis testing will be performed.",[60,61,62,63,64,65,66],"Pressure Ulcers","Pressure Ulcers Stage III","Pressure Ulcer Prevention","Pressure Ulcer ( Stage 2-3)","Biofilm Formation","Biofilm","Biofilm Removal",[68,69,70,71],"Pressure ulcers","biofilms","primary prevention","antimicrobial agents","NOT_YET_RECRUITING","2026-02-06",{"date":75,"type":37},"2026-02-10",{"date":77,"type":22},"2026-01-30",{"date":79,"type":22},"2026-09-30",{"name":43,"class":44},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":45},"100555468","colorectal-surgery-a-new-robotic-platform-hugo-ras-100555468","NCT06512480","Colorectal Surgery, a New Robotic Platform (Hugo Ras)","Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.","Inclusion Criteria:\n\n* Pacientes intervenidos de forma programada de procedimientos en cirugía colorrectal abdominal (neoplasia de colon, neoplasia de recto, diverticulosis, resección intestinal, cirugía transanal mínimamente invasiva (TAMIS), con la plataforma robótica Hugo™ RAS, en régimen de protocolos de rehabilitación multimodal (protocolos ERAS) (ANEXO 2).\n* Edad mayor o igual a 18 años.\n\nExclusion Criteria:\n\n* Pacientes intervenidos mediante abordaje inicial laparoscópico o abierto.\n* Resecciones colorrectales de carácter urgente.\n* Pacientes menores de 18 años.\n* Existencia de otros procesos quirúrgicos concomitantes.\n* Deterioro cognitivo severo que imposibilita la colaboración del paciente.\n* Pacientes diagnosticados en estadio IV oncológico.\n* Pacientes que rechacen participar",{"count":89,"type":22},40,"1 Year","OBSERVATIONAL","A novel robotic platform -Hugo Robotic Assisted Surgery (RAS)- has been introduced with several innovations that may prove advantageous for surgeons such as an open console and four interchangeable modular arms. Our study aims to evaluate the safety, efficacy and potential impact of this platform in the surgical treatment of colorectal pathology.",[94],"Colorectal Surgery",[96,97,98,99],"Robotic surgery","colorrectal surgery","Hugo™ RAS system","Surgical Innovations","2024-07-20",{"date":102,"type":37},"2024-07-23",{"date":104,"type":37},"2024-07-09",{"date":106,"type":22},"2027-07-09",{"name":43,"class":44},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":116,"minAge":4,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100555760","technologies-to-improve-qol-of-prostate-cancer-100555760","NCT06516276","Technologies to Improve QoL of Prostate Cancer","Application of New Technologies to Improve the Quality of Life of Prostate Cancer Patients:","MIO","Inclusion Criteria:\n\n* Patients histologically diagnosed with prostate cancer\n* Metastases confirmed by validated imaging studies\n* Not meet criteria for castration resistance.\n\nExclusion Criteria:\n\n* Do not have a smartphone device\n* Refuse to participate\n* Not sign the informed consent.","MALE",{"count":118,"type":22},98,[25],"The M.I.O Project, which stands for Comprehensive Oncological Medicine, aims to comprehensively and multidisciplinary address the effects of prostate cancer, specifically in patients with hormone-sensitive metastatic prostate cancer (HSMPC), an advanced stage of the disease that still offers prolonged survival due to new medications. The proposal seeks to develop a healthcare approach that promotes self-care and improves the physical and mental health of patients.\n\nDespite growing scientific evidence supporting an integrative approach in oncological care, the provision of personalized options for exercise, nutrition, and psychological therapy before, during, and after diagnosis remains limited. The project proposes to develop tools such as a dedicated mobile application that provides HSMPC patients access to various resources and therapies to improve their health, focusing on nutrition, exercise, and emotional well-being.\n\nM.I.O represents an innovative and holistic approach to addressing these patients' needs and improving their overall well-being. The main goal is to measure the quality of life of the application users through validated questionnaires in a randomized health education study to assess if there is a substantial improvement in their well-being.",[122],"Prostate Cancer","2024-07-18",{"date":102,"type":37},{"date":126,"type":22},"2024-10-01",{"date":128,"type":22},"2025-12-31",{"name":43,"class":44},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":45},"100290737","organ-preservation-in-locally-advanced-rectal-cancer-100290737","NCT03064646","Organ Preservation in Locally Advanced Rectal Cancer","ORGAN PRESERVATION AFTER NEOADJUVANT TREATMENT FOR LOCALLY ADVANCED RECTAL CANCER","PRONAR","Inclusion Criteria:\n\n* Patients with confirmed histopathological diagnosis of rectal adenocarcinoma.\n* Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy.\n* Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI.\n\nExclusion Criteria:\n\n* Evidence of distant metastases.",{"count":139,"type":22},30,[25],"PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment.\n\nThe main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival.\n\nThe secondary objective is to assess local relapse, distant relapse and quality of life.",[143],"LOCALLY ADVANCED RECTAL CANCER",[145,146,147],"ORGAN PRESERVATION","WATCH AND WAIT","TRANSANAL ENDOSCOPIC MICROSURGERY","2018-09-25",{"date":150,"type":37},"2018-09-27",{"date":152,"type":37},"2017-03-10",{"date":154,"type":22},"2027-02",{"name":43,"class":44},""]