[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"validation-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:validation-study":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,77,98,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631763","spanish-validation-of-koquss-40-questionnaire-assessing-qol-of-gastric-cancer-patients-after-gastrectomy-spquss-41-100631763",false,"NCT07504913","Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41","SPQUSS-41: Validación Del Cuestionario de Calidad de Vida KOQUSS-40 Para Los Pacientes Con gastrectomía Por cáncer gástrico [SPQUSS-41]","SPQUSS-41","Inclusion Criteria:\n\n* Patients operated on for gastric cancer with curative intent from 1 month postoperatively up to the last 5 years\n* Adult patients over 18 years old\n* No recurrence of the disease\n* Patients who have given their informed consent to participate in the Spanish EURECCA Registry of Esophagogastric Cancer and have signed the specific consent for the SPQUSS-4 study\n\nExclusion Criteria:\n\n* First 30 days after surgery and\u002For patients with postoperative complications requiring more than 30 days of hospitalization.\n* Patients who do not give their consent to participate in the study will be excluded.\n* Patients with a history of other neoplasms.\n* Patients with disseminated gastric cancer or candidates for palliative surgery, as well as those patients who do not give their consent to participate.","ALL","18 Years",{"count":20,"type":21},505,"ESTIMATED","OBSERVATIONAL","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.",[25,26],"Stomach Neoplasms","Validation Study",[28,29,30,31],"Stomach neoplasms","Validation study","Surveys and questionnaires","Quality of life","RECRUITING","2026-03-26",{"date":35,"type":36},"2026-04-01","ACTUAL",{"date":38,"type":36},"2025-05-03",{"date":40,"type":21},"2026-12-01",{"name":42,"class":43},"Parc de Salut Mar","OTHER",6,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100553428","validation-of-the-experience-sampling-dietary-assessment-method-100553428","NCT06485960","Validation of the Experience Sampling Dietary Assessment Method","Validation of the Experience Sampling Dietary Assessment Method (ESDAM)","YONAS","Inclusion Criteria:\n\n* Signed informed consent\n* Having a smartphone and being capable of using the smartphone and apps\n* Having a freezer at home\n* Sufficient knowledge of the Dutch language to understand and participate in the study\n* Having a stable body weight (body weight not changed by 5% last 3 months)\n* Not aiming to gain or lose weight during the study period\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Not following a specific diet for medical reasons (i.e. coeliac disease)",true,"65 Years",{"count":56,"type":21},115,"A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.",[26],[60,61,62,63,64,65,66],"Dietary assessment","Validation","Experience Sampling","digital health","digital biomarkers","doubly-labeled water","ESM","2025-12-03",{"date":69,"type":36},"2025-12-10",{"date":71,"type":36},"2025-10-09",{"date":73,"type":21},"2026-03",{"name":75,"class":43},"KU Leuven",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":76},"100581789","validation-study-of-the-italian-version-of-the-assessment-of-life-habits-40-scale-life-h-for-measuring-participation-in-children-with-disabilities-aged-5-to-13-years-100581789","NCT06854874","Validation Study of the Italian Version of the \"Assessment of Life Habits 4.0\" Scale (LIFE-H) for Measuring Participation in Children With Disabilities Aged 5 to 13 Years","Inclusion Criteria:\n\n* caregivers of children with physical, sensory, cognitive disabilities between the ages of 5 and 13 years.\n\nExclusion Criteria:\n\n* Parents who do not master the Italian language\n* Absence of signed informed consent from parents","5 Years","13 Years",{"count":86,"type":21},180,"BACKGROUNG In Italy there are still few translated and validated instruments to assess participation.\n\nIn the field of pediatric rehabilitation, among the tools available internationally, one of the most comprehensive and widely used is the Assessment of Life Habits, or LIFE-H, now in its 4.0 version. The LIFE-H scale was originally developed in French and implemented by the International Network on the Disability Creation Process - INDPC, also known as the Quebec Model or Handicap Creation Process.\n\nInternationally, the \"LIFE-H\" scale has been translated and validated in several languages. The scale is among the most comprehensive and detailed instruments in the literature: it consists of 90 items (life habits), divided into 12 domains, 6 of which are for regular activities (e.g., communication and mobility), and 6 for social roles (responsibility and interpersonal relationships).\n\nA study of Italian translation and cultural adaptation of the LIFE-H scale 4.0 for children aged 5 to 13 years, was carried out during 2020-2021.\n\nThe scale and its related user manual in Italian version have also been insert into the platform of the Canadian originator company \"Réseau international sur le Processus de production du handicap\" - RIPPH).\n\nAIM The goal of the study is to assess the intra- and inter-rater reliability, internal consistency and construct validity of the scale in its Italian version.\n\nMETHOD Participants will be recruited from the pediatric rehabilitation centers of Toscana Centro , AOU Meyer IRCCS and AORN Santobono-Pausilipon Subjects interviewed will be caregivers of children with disabilities between the ages of 5 and 13 years. Care-givers of children with physical, sensory and cognitive disabilities, regardless of diagnosis, will be included in the study, as per the scale's user manual.\n\nFirst Part Step 1: Presentation of the project through informational documentation to pediatric rehabilitation physical therapists of the territorial services of Toscana Centro and AOU Meyer IRCCS, who will identify candidate families for the study.\n\nStep 2: Collection of informed consent by the investigating physical therapist in the referral area.\n\nStep 3: TEST: Administration of the LIFE-H 4.0 \u002F 5-13 years scale by an investigator (FT 1). As stipulated among the modes of administration, the questionnaire will be completed by the reference person or parent of the child with support from the experimenter. The administration will be done via video call on Google Meet platform, which platform is deemed most suitable in terms of use for families.\n\nStep 4 : RETEST: After an interval of 15 days, second administration of the questionnaire will be carried out in the same manner and by the same experimenter.\n\nStep 5 : Analysis and comparison of the collected data. Second part Step 6: Making contact with subjects who had adhered to both phases of the study (as indicated in the informed consent signed in step one) and re-enrollment through informational documentation to pediatric rehabilitation physical therapists from the territorial services of Toscana Centro, AOU Meyer IRCCS, and AORN Santobono-Pausilipon, who will identify candidate families for the study.\n\nStep 7: Collection of informed consent from the investigating physical therapist in the target area.\n\nStep 8: TEST: Administration of the LIFE-H 4.0 \u002F 5-13 years scale by an investigator (FT 3). As stipulated among the modes of administration, the questionnaire will be completed by the reference person or parent of the child with support from the experimenter. The administration will be done via video call on Google Meet which platform is deemed most suitable in terms of family use.\n\nStep 9: RETEST: Administration of the LIFE-H 4.0 \u002F 5-13 years scale by an experimenter (FT 4) 15 days apart in the same manner.\n\nStep 10: To complete the validation process (Construct Validity), the PEM-CY questionnaire will be provided to parents participating in the second phase of the study. The instrument was chosen, among the few available in the Italian language, because of features in common with the Life-H scale. The caregivers will be able to fill out the paper version of the questionnaire themselves. The latter will be kept within the child's medical record; the investigators will only be informed of the final score of the questionnaire.\n\nstep 11: analysis and comparison of collected data SAMPLE SIZING AND STATISTICAL METHODS OF DATA ANALYSIS With respect to the required sample size, contacts have been made with the Canadian authors of the LIFE-H scale (International Network on the Disability Creation Process - INDPC), who suggest a minimum minimum sample size of 30 subjects. Also taking into consideration other scale validation articles, we therefore plan to enroll 30 subjects for Phase 1 (intra-operator concordance and internal consistency) and 130 subjects for Phase 2 (inter-operator concordance and construct validity of construct). Analysis of the results of the LIFE-H questionnaire",[26],"2025-03-04",{"date":91,"type":36},"2025-03-07",{"date":93,"type":36},"2024-02-23",{"date":95,"type":21},"2026-12",{"name":97,"class":43},"Meyer Children's Hospital IRCCS",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100578695","the-aims-of-the-study-are-to-translate-the-index-of-professional-governance-ipg-30-into-italian-and-validate-it-and-to-assess-the-state-of-professional-governance-in-an-italian-hospital-ismett-100578695","NCT06814639","The Aims of the Study Are to Translate the Index of Professional Governance (IPG 3.0) Into Italian and Validate It and to Assess the State of Professional Governance in an Italian Hospital (ISMETT)","\"Index of Professional Governance\" Tool: a Multicentric Validation and Measuring Professional Governance in an Italian Hospital Setting","Inclusion Criteria:\n\n* 1 year of professional seniority\n* possess adequate linguistic skills certified by passing an English test (prepared by the linguistic services of the promoting center).",{"count":106,"type":21},75,"Professional Governance (PG) is a way to actualize better work environments and structural empowerment. PG has a history over many years in the healthcare industry and has been defined as multidimensional organizational characteristics that encompass the structure and processes through which professionals direct, control and regulate one another's goal-oriented efforts. Multiple studies over the years have shown that PG can lead to empowered personnel and quality of care delivered.\n\nIn many organizations, governance is primarily controlled by management. The responsibility for managing professional practice should, however, be shared by staff and leaders, and in order to empower staff, they should be engaged in identifying areas for improvement. In addition, evidence-based practice should be enabled by allocating sufficient time, research and access to evidence sources.\n\nThe participation element refers to who creates and participates in governance activities on different levels. Successful professional governance structures have been linked to a positive professional practice environment. An effective structure with true sharing of decision-making between management and personnel will also contribute to optimal patient outcomes.\n\nTo evaluate whether an organization's governance is empowering and professional, it must be measured. Thus, various instruments to measure nurses' participation in professional governance have been presented. The Index of Professional Nursing Governance (IPNG) has been used in more than 250 international healthcare organizations during the last 20 years to evaluate implementation of their management models.\n\nHess created the IPNG for measuring professional governance along a conceptual continuum from traditional, through shared to self-governance models. Hess has since continued to advance the questionnaire. At the same time, an extended tool was created with all professional figures involved, the so called \"Index of Professional Governance\" (IPG). Several revisions have been made over time up to the current version of the IPG 3.0 The IPG measures the governance of hospital-based professional, based on a model of governance derived from the literature, in 5 dimensions: personnel, information, resources, participation and practice. Those five dimensions are covered by 50 items. Respondents use a 5-point scale to identify the group that dominates certain areas of governance stated in the items, ranging from 'management\u002Fadministration only' (1p), through 'equally shared by staff and management\u002Fadministration' (3p) to 'staff only' (5p). The points for each dimension, and overall governance, are then organized together, analyzed and used to place the organization's governance on the continuum from traditional to self-governance.\n\nPreviously translated from its original language, English-American into Arabic, British, Finnish, French, German, Korean, Portuguese, it is structured in five dimensions: staff, information, resources, participation and practice. These 5 dimensions are analyzed in 50 items.\n\nAims of the study:\n\n1. To translate the Index of Professional Governance (IPG 3.0) into Italian and validate it;\n2. To assess the state of professional governance in an Italian hospital (ISMETT).",[26],[110,111,112,113],"IPG tool","professional governance","translation","validation","NOT_YET_RECRUITING","2025-02-03",{"date":117,"type":36},"2025-02-07",{"date":119,"type":21},"2025-02-06",{"date":121,"type":21},"2025-10-31",{"name":123,"class":43},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":134,"conditions":135,"keywords":140,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":76},"100569867","validation-of-the-greek-postoperative-quality-of-recovery-score-15-100569867","NCT06699823","Validation of the Greek Postoperative Quality of Recovery Score 15","Cultural Adaptation and Validation of the Greek Version of the Postoperative Quality of Recovery Score 15 (QoR-15Gr)","(QoR-15Gr)","Inclusion Criteria:\n\n* Age\\>18 years old\n* Scheduled elective general surgery under general anesthesia\n\nExclusion Criteria:\n\n* Emergency surgery\n* Poor Greek comprehension\n* Inability to give consent\n* A psychiatric or neurological condition that precludes cooperation\n* Known history of alcohol or drug dependence\n* Life-threatening postoperative complications\n* Postoperative admission to ITU",{"count":133,"type":21},150,"The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.",[136,137,138,26,139],"Postoperative Recovery","Quality of Recovery From Anaesthesia","PROMs","Cultural Adaptation",[141,142,143,113,144],"quality of recovery","patient reported outcomes","QoR-15","cultural adaptation","2024-11-22",{"date":147,"type":36},"2024-11-26",{"date":149,"type":21},"2024-12-01",{"date":151,"type":21},"2025-02-28",{"name":153,"class":43},"IASO Thessalias"]