[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":356},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,88,118,141,167,198,222,246,278,303,328],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643220","impact-of-a-multicomponent-physical-exercise-program-on-the-functional-capacity-of-patients-admitted-to-an-intermediate-care-hospital-vivifrail-for-a-better-vig-frail-100643220",false,"NCT07637383","IMPACT OF A MULTICOMPONENT PHYSICAL EXERCISE PROGRAM ON THE FUNCTIONAL CAPACITY OF PATIENTS ADMITTED TO AN INTERMEDIATE CARE HOSPITAL. VIVIFRAIL FOR A BETTER VIG-FRAIL.","* baseline Barthel Index ≥60\n* ability to communicate, ambulate, and complete the exercise program","ALL","65 Years",{"count":18,"type":19},120,"ESTIMATED","INTERVENTIONAL",[22],"NA","INTRODUCTION Physical exercise in frail individuals has demonstrated benefits in variables such as reduced mortality risk and improved frailty and quality of life. Specifically, the most beneficial type appears to be multicomponent exercise, which includes strength, endurance, balance, and gait training. Within this field, the VIVIFRAIL project is an internationally recognized physical exercise promotion program.\n\nOBJECTIVES To analyze the effects of an individualized multicomponent physical exercise program as an effective method for preventing\u002Fimproving functional status and frailty in individuals admitted to an intermediate care hospital (ICH).\n\nTo assess whether improvements in functionality\u002Ffrailty are maintained 3-4 months after discharge and to evaluate the impact of the program on quality of life variables and health indicators at 6 months.\n\nMETHODOLOGY Design: randomized clinical trial with two groups (control and intervention) and 6 months of follow-up.\n\nStudy population: adults older than 65 years admitted to an intermediate care hospital (ICH).\n\nInclusion criteria: baseline Barthel Index ≥60, ability to communicate, ambulate, and complete the exercise program.\n\nPrimary variables: functionality (Short Physical Performance Battery - SPPB) and frailty (Frail-VIG Index).\n\nSecondary variables: grip strength, depressive symptoms, fear of falling, mortality, institutionalization, hospital admissions\u002Femergency room and primary care visits, level of physical activity, medications (number, analgesics, opioid use, antidepressants, anxiolytics), and quality of life.\n\nSample size: assuming a 15% loss to follow-up, the final required sample size is 120 patients. Linear mixed-effects models will be used with a significance level of 0.05.",[25,26],"Functionality","Fragility",[28,29,30],"Frailty","physical exercise","Quality of life","RECRUITING","2026-06-04",{"date":34,"type":35},"2026-06-09","ACTUAL",{"date":37,"type":35},"2026-02-18",{"date":39,"type":19},"2027-02",{"name":41,"class":42},"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":15,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":69,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},"100626909","thromboembolic-risk-associated-to-high-atrial-fibrillation-risk-100626909","NCT07441759","throMboembolic Risk Associated To High atrIal Fibrillation riSk","Economic, Clinical, and Societal Impact of Early Thromboembolic -Risk Detection in High-Risk Atrial Fibrillation: A Model -Based Evaluation of the MATHIAS Strategy.","MATHIAS","Inclusion Criteria (PREFATE study): assessed at baseline\n\n* Adults aged 65-95 years without prior AF and at High risk of AF, according to the risk score validated in the AFRICAT (Atrial Fibrilation Research in CATalonia) study. This scale considers the following variables for risk calculation: sex, age, weight, cardiac rate and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 (doubled), diabetes mellitus, prior stroke or transient ischemic attack (doubled), vascular disease, age 65-74, female) score.\n* with active records in the HCC3\u002FCMBD systems\n* CHA2DS2-VASc score≥2.\n* Ability to use a smart phone (or at least the caregiver).\n\nExclusion Criteria: Patients with the following conditions will be excluded (exclusion criteria):\n\n* Previous diagnosis of AF.\n* Previous diagnosis of stroke.\n* Severe cognitive impairment, with a score on the Global Deterioration Scale (GDS)≥3.\n* Severe functional impairment, with a Barthel score ≤60, or modified Rankin score≥4.\n* Active anticoagulant treatment at the inclusion.\n* Vital prognosis less than 1 year.\n* Pacemaker carriers.",true,"95 Years",{"count":55,"type":19},1000,"2 Years","OBSERVATIONAL","Cardiovascular diseases are the leading cause of mortality from treatable conditions in the European Union and the second from preventable causes, with a standardized mortality rate of 257.8 deaths per 100,000 inhabitants. In 2022, more than 1.11 million deaths in individuals under 75 years could have been avoided. Atrial fibrillation (AF) and major adverse cardiovascular events (MACE) are highly prevalent in the elderly and generate substantial healthcare costs. AF significantly increases the risk of MACE and is projected to rise markedly in the coming decades.\n\nIn Europe, AF prevalence is expected to increase 2.5-fold over the next 50 years, with a lifetime risk of 1 in 3-5 individuals after age 55. AF-related strokes are projected to increase by 34%, and ischemic strokes in individuals over 80 are expected to triple between 2016 and 2060. Additionally, a 27% increase is anticipated among stroke survivors who subsequently develop AF or related conditions. AF substantially impacts morbidity, mortality, and disease progression, and early detection and treatment are crucial to prevent severe outcomes.\n\nEuropean action plans (2018-2030) and the 2024 ESC\u002FESO guidelines emphasize early detection and management of AF in primary care. Although several AF prediction models exist, their integration into clinical practice remains challenging. AF represents a clinical continuum, with thrombotic risk present even before arrhythmia onset. High-risk patients for AF also show a high incidence of MACE, defined as a composite of myocardial infarction, stroke, systemic embolic events, and cardiovascular death.\n\nThe proposed strategy involves developing and clinically validating an Artificial Intelligence (AI) model to improve early thrombotic risk prediction in patients at high risk of AF, using MACE as the primary outcome. This model aims to outperform the traditional CHA₂DS₂-VASc score by incorporating both classical and emerging clinical factors. The estimated timeline from clinical validation to commercialization is approximately 48 months.\n\nAI-based prediction is expected to enable personalized treatment, reduce the incidence of MACE, hospitalizations, and disability, and improve cost-effectiveness, ultimately decreasing the social and economic burden of AF and stroke in Europe.",[60,61,62,63,64,65,66,67,68],"MACE","Atrial Fibrillation (AF)","Quality-adjusted Life-years","Electronic Health Records","Thromboembolic Risk","Cost-effectiveness Analysis","Artificial Intelligence (AI)","Cardio Vascular Disease","Cardio-cerebrovascular Disease",[70,71,72,73,74,75,76,77,78],"Atrial fibrillation","Thromboembolic risk","Artificial intelligence","Stroke","Major Adverse Cardiovascular Events","Sex differences","Primary care","Cost-effectiveness analysis","Quality-adjusted life-years","NOT_YET_RECRUITING","2026-02-27",{"date":82,"type":35},"2026-03-02",{"date":84,"type":19},"2026-07-06",{"date":86,"type":19},"2028-12-31",{"name":41,"class":42},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":20,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":43},"100552055","dog-assisted-therapy-in-children-during-blood-or-dental-extraction-100552055","NCT06468111","Dog-Assisted Therapy in Children During Blood or Dental Extraction.","Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project","Extra-can","Inclusion Criteria:\n\n* Age between 3 and 12 years old.\n* Need a blood or dental extraction.\n* Willing to participate in the study on a voluntary basis.\n* Delivery of the information sheet and signature the informed consent.\n\nExclusion Criteria:\n\n* If in the initial interview they declared having allergy or fear of dogs.\n* Have aggression disorder towards dogs.\n* Not want to participate in the study.","3 Years","12 Years",{"count":18,"type":19},[22],"The purpose of the present study is to evaluate the efficacy of Animal Assisted Therapy (AAT) during blood extraction or dental procedures 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. These objectives will be accomplished through a randomized open label two-arm controlled study of AAT for children who need a blood or dental extraction.",[102],"Emotional Stress",[104,105,106,107,108,109],"Animal-assisted Intervention","Children","Primary Healthcare Centre","Venipuncture","Dental fear","Distraction emotional support animals","2025-09-08",{"date":112,"type":35},"2025-09-15",{"date":114,"type":35},"2022-01-01",{"date":116,"type":19},"2025-12-30",{"name":41,"class":42},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":20,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":4},"100603139","effect-of-a-multicomponent-therapeutic-exercise-program-in-primary-care-on-frailty-and-sarcopenia-in-older-adults-100603139","NCT07132632","Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults","FRACTEP-65","Inclusion Criteria:\n\n* Adults aged 65 years or older, receiving care from primary care physiotherapists at participating health centers.\n* Clinical Frailty Scale (CFS) score between 4 and 6 (indicating vulnerable, mild, or moderate frailty).\n* Ability to walk independently, with or without assistive devices (excluding habitual wheelchair use).\n* Clinically stable, defined as the absence of acute events or clinical decompensation in the previous 4 weeks.\n* Sufficient cognitive ability to understand and follow basic instructions, or the availability of an actively involved caregiver (MMSE ≥ 20 or equivalent).\n* Signed informed consent from the participant or their legal representative.\n\nExclusion Criteria:\n\n* Diagnosis of severe frailty or advanced dependence (CFS ≥ 7).\n* Severe neurological or musculoskeletal disorders that limit safe exercise participation (e.g., Parkinson's disease, stroke with major sequelae, disabling arthropathies).\n* Uncontrolled cardiac, respiratory, or other medical conditions that contraindicate physical activity.\n* Moderate to severe cognitive impairment, defined by MMSE \\\u003C 20 or a clinical diagnosis of dementia with significant functional limitations.\n* Simultaneous participation in other structured physical intervention programs.",{"count":126,"type":19},60,[22],"Background:\n\nFrailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Both conditions are prevalent among older adults and represent a growing public health challenge as the population ages.\n\nObjective:\n\nThis study aims to evaluate the effectiveness of a multicomponent therapeutic exercise program in reducing frailty and improving clinical parameters related to sarcopenia in community-dwelling older adults aged 65 years or older who attend primary care centers.\n\nStudy Design:\n\nThis is a quasi-experimental, multicenter, single-group pre-post clinical trial. The study includes two phases: a control phase (pre-intervention observation) and an experimental phase (intervention). Each participant will act as their own control.\n\nParticipants:\n\n60 older adults aged 65 or older will be recruited from primary care centers in the Baix Llobregat region (Catalonia, Spain). Eligibility criteria include mild to moderate frailty (Clinical Frailty Scale 4-6), ability to walk independently (with or without a walking aid), cognitive ability to follow instructions (MMSE ≥ 20), and clinical stability. Exclusion criteria include severe frailty, major cognitive impairment, acute illness, or participation in another structured exercise program.\n\nIntervention:\n\nParticipants will take part in a 12-week multicomponent exercise program including 8 supervised sessions at the primary care center and 4 home-based sessions. Each session will last 60 minutes and include strength training, balance exercises, aerobic activity, and flexibility. The program follows FITT-VP principles (frequency, intensity, time, type, volume, and progression). Home sessions will be supported with illustrated manuals and biweekly follow-up calls.\n\nOutcomes:\n\nThe primary outcome is the change in frailty level measured by the Clinical Frailty Scale (CFS). Secondary outcomes include handgrip strength, SARC-F score, Short Physical Performance Battery (SPPB), 4-meter walk test, Timed Up and Go (TUG), muscle mass index, rectus femoris and vastus lateralis ultrasound, cognitive status (MMSE), nutritional status (MNA-SF), falls, and hospitalizations. Assessments will be conducted at baseline (month 0), after the control phase (month 3), and after the intervention (month 6).\n\nSignificance:\n\nThis study will provide evidence on the medium-term effectiveness of a short, structured, and feasible intervention implemented in real-life primary care settings. If effective, this program could be integrated into preventive strategies to reduce frailty and sarcopenia, promote autonomy, and improve the quality of life among older adults. Results will inform clinical guidelines and contribute to the development of scalable interventions for aging populations.",[28,130,131,132],"Sarcopenia","Aging","Exercises Therapy","2025-08-20",{"date":135,"type":35},"2025-08-27",{"date":137,"type":19},"2025-11-02",{"date":139,"type":19},"2026-12-31",{"name":41,"class":42},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":15,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":43},"100594462","experience-with-the-use-of-continuous-glucose-monitoring-cgm-devices-in-people-with-type-2-diabetes-mellitus-100594462","NCT07019753","Experience With the Use of Continuous Glucose Monitoring (CGM) Devices in People With Type 2 Diabetes Mellitus","Glucocavi","Inclusion Criteria:\n\n* Have been using a CGM sensor daily for diabetes management for the past 12 months or more.\n* Treatment with intensive insulin therapy (basal bolus regimen with 3 or more daily doses of insulin).\n* Agree to participate in the study.\n\nExclusion Criteria:\n\n* Cognitive impairment measured by the SPMSQ test with a score of 3 or more errors.\n* Being institutionalised.\n* Have another person responsible for monitoring the device and making decisions related to diabetes (insulin adjustment, carbohydrate rations, etc.).\n* Language difficulty: not being able to hold a fluent conversation in Catalan or Spanish for 30-60 minutes.","18 Years",{"count":150,"type":19},5,"Background: In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. Some qualitative studies have been conducted to assess the experiences of patients with type 2 diabetes mellitus (T2DM) using CGM devices, but none have been conducted in a Mediterranean country. Furthermore, there are differences in the amount of time study participants used the CGM device, ranging from 14 days to 6 months, and in some studies, participants did not receive insulin treatment.\n\nObjectives: To understand the benefits and barriers described by people with type 2 diabetes mellitus who use CGM devices through inductive thematic analysis of interviews conducted with them.\n\nMethodology: Qualitative study with a phenomenological approach and conversational technique. Adults with T2DM who have used a CGM device continuously for the past 12 months will be interviewed individually.\n\nData analysis: They will be analyzed using inductive thematic analysis. The interviews will be transcribed verbatim, along with any relevant data collected by the other researcher present at the interview. Three researchers will then conduct a preliminary analysis, from which codes will be agreed upon and themes, categories, and subcategories will be proposed through triangulation among the researchers. This will be done inductively, through analysis, in-depth reflection, and debate among the three researchers.\n\nApplicability and relevance: Knowing the opinion of people with T2DM who use CGM devices, as well as the barriers and facilitators they find to its use will help healthcare professionals to better understand their patients and thus provide more personalised and closer healthcare. In addition, healthcare managers and administrators will be able to find out whether patients find it useful to use a CGM device, whether they reduce the use of capillary glycaemia strips, whether they become more aware of their disease and increase their self-monitoring, etc. All this will help to decide whether it is beneficial to extend the indication of these devices to more people with type 2 diabetes.",[153,154,155],"Patient Satisfaction","Continuous Glucose Monitoring","Type 2 Diabetes Mellitus (T2DM)",[154,153,155,157,158],"Quality of Life","Primary Care","2025-07-04",{"date":161,"type":35},"2025-07-09",{"date":163,"type":19},"2026-01",{"date":165,"type":19},"2026-10-31",{"name":41,"class":42},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":15,"minAge":148,"maxAge":16,"enrollmentInfo":175,"targetDuration":4,"studyType":20,"phases":177,"briefSummary":178,"conditions":179,"keywords":185,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":43},"100592090","energy2mob-study-obesity-management-in-bergued-100592090","NCT06988904","ENERGY2MOB STUDY: OBESITY MANAGEMENT IN BERGUEDÀ","EFFECTIVENESS OF THE GROUP-BASED NUTRITION EDUCATION PROGRAMME FOR OBESITY MANAGEMENT IN BERGUEDÀ: A RANDOMISED CLINICAL TRIAL. ENERGY2MOB STUDY","ENERGY2MOB","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Overweight (BMI 27-30 kg\u002Fm²) or obesity (BMI 30-40 kg\u002Fm²)\n* Availability to attend at least 80% (6 out of 8) of the group sessions\n\nExclusion Criteria:\n\n* Significant language barriers (unable to communicate in Catalan or Spanish)\n* Previous bariatric surgery\n* Moderate to severe cognitive impairment\n* Severe psychiatric disorders preventing participation in group sessions",{"count":176,"type":19},136,[22],"Background: Obesity is a prevalent multifactorial disease worldwide and has become a significant public health concern. The latest data from the 2022 Catalonia Health Survey show that 56.2% of men and 43.7% of women are overweight or obese, and 39% of children aged 6 to 12 years have excess weight. Excess adiposity poses a health risk as it is associated with various chronic diseases such as type 2 diabetes mellitus, hypertension, and dyslipidaemia, all of which affect quality of life and increase mortality risk.\n\nHypothesis: The Energy2MOB obesity management programme in Berguedà is a group-based intervention incorporating nutrition education and physical activity. It aims to reduce excess body weight and the risk of chronic diseases, including type 2 diabetes mellitus, dyslipidaemia, and hypertension, through a multicomponent approach that enhances dietary habits, physical activity, and emotional eating regulation.\n\nObjectives\n\n* Assess the effectiveness of the Energy2MOB programme in reducing body weight by 5-10% among adults with obesity in the Berguedà health region.\n* Measure lifestyle modifications, including dietary habits, physical activity, and emotional eating.\n\nMethodology: A randomised clinical trial with two groups (control and intervention) over one year, including individuals aged 18-65 years in the Berguedà health region with overweight grade II (BMI 27-30 kg\u002Fm²) or obesity (BMI 30-40 kg\u002Fm²). Exclusion criteria include significant language barriers, previous bariatric surgery, moderate to severe cognitive impairment, and severe psychiatric disorders preventing participation in sessions. Participants must attend at least 80% of the programme.\n\nMeasurements\n\n* Sociodemographic factors: sex, age, education level, marital status, employment status.\n* Lifestyle factors: alcohol and tobacco use, dietary habits, physical activity, emotional eating, health-related quality of life.\n* Anthropometric parameters: body weight, height, BMI, waist circumference.\n* Blood pressure, medication use, biochemical parameters (fasting glucose, glycated haemoglobin, lipid profile, liver and kidney function markers, C-reactive protein).\n\nStatistical Analysis: Accepting an alpha risk of 0.05 and a statistical power above 0.8 in a bilateral contrast, 68 subjects per group are required to detect a difference of at least 2.5 kg. A common standard deviation of 4.77 is assumed, with an estimated 15% dropout rate. Sample size calculations were performed using GRANMO version 8.0 (https:\u002F\u002Fwww.datarus.eu\u002Fca\u002Faplications\u002Fgranmo\u002F; consulted in November 2024).\n\nExpected Outcomes, Applicability, and Relevance: This study aims to generate scientific evidence on the effectiveness of multicomponent group-based interventions focused on improving nutrition, physical activity, and psychological well-being in obesity and chronic disease management. It seeks to create an environment that facilitates behavioural changes, leading to weight reduction and improved quality of life. The findings will also contribute to the development of a practical guide for addressing excess weight in primary healthcare settings.\n\nKeywords (maximum 6): Adult obesity, primary health care, group interventions, dietary interventions, multicomponent interventions, Mediterranean diet.",[180,181,182,183,184],"Mediterranean Diet","Overweight or Obese Adults","Exercise Therapy","Cardiovascular Diseases","Psychological Well Being",[186,187,188,189],"obesity and overweight","primary health care","Mediterranean diet","dietary interventions","2025-05-22",{"date":192,"type":35},"2025-05-25",{"date":194,"type":19},"2025-06-07",{"date":196,"type":19},"2026-03-07",{"name":41,"class":42},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":15,"minAge":148,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":20,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":4},"100588653","therapeutic-exercise-program-of-physiotherapy-using-telerehabilitation-on-chronic-phase-stroke-patients-100588653","NCT06944197","Therapeutic Exercise Program of Physiotherapy Using Telerehabilitation on Chronic Phase Stroke Patients","Effectiveness of a Therapeutic Exercise Program of Physiotherapy Through the Use of Telerehabilitation on Functional Capacity for Patients With Chronic Phase Stroke: Multicenter Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n* Age 18 years or older\n* Medical diagnosis of stroke\n* Stroke condition present for more than 6 months\n* Physical sequelae secondary to stroke\n* Minimum score of 1 on the Medical Research Council scale for overall muscle strength of affected limbs\n* Maximum score of 3 on the Modified Ashworth scale for overall muscle tone of affected limbs\n* Maximum score of 4 on the Modified Rankin scale for disability\n* Access to computer equipment (tablet, desktop or laptop computer, or smartphone)\n\nExclusion Criteria:\n\n* Undergoing other non-pharmacological physical treatments for stroke sequelae improvement and\u002For maintenance\n* Previous decreased motor functional capacity with a Barthel scale score of less than 60 points\n* Cognitive and\u002For language barriers that hinder the understanding of informed consent and intervention\n* Participation in another clinical trial during the study period that may impact the results of the variables to be evaluated",{"count":206,"type":19},75,[22],"Stroke is the main cause of physical disability in adults in Catalonia. Despite this, there is a lack of evidence on physiotherapy interventions during the chronic phase of the pathology. The objective of the study is evaluate the effectiveness of a therapeutic exercise program of Physiotherapy through the use of Telerehabilitation on functional capacity in activities of daily living in patients with stroke in chronic phase. For this purpose, the investigator conduct a multicenter randomized controlled clinical trial. A minimum of 75 participants will be recruited in three intervention groups (n=25 each group) from Primary Care Centers of the Institut Català de la Salut. The sample will be made up of people over 18 years of age with a medical diagnosis of Stroke, in a chronic phase and with physical sequelae. Research team will evaluate as the main variable the functional capacity for the management of activities of daily living (Barthel Index); as well as sociodemographic variables. Also secondary variables such as motor function (MMAS), muscle tone of affected limbs (MAS), muscle strength of affected limbs (MRC), balance (PASS), gait efficiency (WGS, 4MWT), perception of musculoskeletal pain (BPI), perception of fatigue (FSS), risk of falls (TUG), perception of quality of life (NEWSQOL), and perception of quality of life (NEWSQOL), and perception of perceived subjective change after treatment (GROC). The variables will be collected, before and after the intervention , which will consist of 30 sessions (3 sessions\u002F10 weeks). The analysis will be using a mixed linear model (ANOVA 3X3). Significance level p\\\u003C0.05.",[73],[211,158,212,213],"Chronic disease","Therapeutic exercises","Telerehabilitation","2025-04-27",{"date":216,"type":35},"2025-04-30",{"date":218,"type":19},"2025-05-08",{"date":220,"type":19},"2027-05-03",{"name":41,"class":42},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":15,"minAge":230,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":20,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":245,"locationsCount":43},"100562689","acompanyem-a-community-program-accessing-lonely-disabled-neighbors-young-elder-and-midlife-100562689","NCT06606431","ACOMPANYEM: A COMmunity Program Accessing Lonely, Disabled Neighbors (Young, Elder, and Midlife)","Accompaniment of Isolated People by Volunteers From the Neighborhood: a Community Mixed Quasi-experimental\u002FQualitative Clinical Trial","ACOMPANYEM","Inclusion Criteria:\n\nPreviously detected by community and professional assets among people over 16 years of age with the following criteria:\n\n* Disabled physical or mental homebound persons.\n* Unwanted loneliness, with difficulty in accessing other assets of the social prescription program.\n* less than 8 on the Oslo Social Support Scale or less than 20 on the LSNS-R scale or less than 2 on the LSNR-6 scale in people over 65 years of age.\n\nExclusion Criteria:\n\n* Impossibility of communication\n* End-of-life situations.","16 Years",{"count":232,"type":19},8,[22],"Social prescription prioritizes interventions for people at risk of social isolation or unwanted loneliness based on community assets and offers them a series of activities that can contribute to their emotional well-being as a healthy alternative to medicalized healthcare. Disabled homebound people deal with more difficulty accessing the social health assets available in the community. Volunteers from the same neighborhood may accomplish the social function of accompaniment and listening accessing them at home or walking them out to attain social prescription goals. The Community Emotional Well-Being Referent (REBEC) may enhance all of this by conducting emotional counseling and management groups for volunteers.\n\nOBJECTIVE: To evaluate the effectiveness of a community intervention of accompaniment and emotional management with volunteers on the unwanted loneliness of people with social isolation, their emotional well-being, and their quality of life.\n\nMETHODOLOGY: a community-based quasi-experimental non-randomized pre-post intervention study with control group, and a qualitative study. Candidate detection by the Driving Group, composed of neighborhood organizations and the community health team, was conducted opportunistically. Recruitment of isolated individuals and volunteers was carried out, with registration based on inclusion criteria. Implementation of the multi-level intervention for volunteers and isolated individuals took place at home or by participating in community resources on the street, with parallel support groups for volunteers using REBEC. Each round of participants was followed for three months, continuing until the sample was complete. Qualitative analysis was conducted upon reaching information saturation. In cases where architectural barriers were detected, technical aids (such as portable stairlifts) were proposed, and their impact was studied.",[236,237,238],"Social Isolation or Loneliness","Homebound Persons","Disabled Persons","2024-09-18",{"date":241,"type":35},"2024-09-23",{"date":243,"type":19},"2024-10-01",{"date":139,"type":19},{"name":41,"class":42},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":15,"minAge":148,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":20,"phases":257,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100560762","phase-4-tailoring-antibiotic-duration-for-respiratory-tract-infections-in-primary-care-100560762","NCT06581367","Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care","Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: a Pragmatic Randomized Controlled Trial","STORM","Inclusion Criteria:\n\n* Either adults with a) acute cough (new cough or worsening of a previous cough) as the predominant symptom which the clinician believes to be a bacterial acute lower RTI, such as community-acquired pneumonia, acute bronchitis or acute chronic obstructive pulmonary disease (COPD) exacerbations, or b) an acute bacterial rhinosinusitis\n* Doctors deem beta-lactam therapy (given every eight hours for a minimum of seven days) is necessary\n\nExclusion Criteria:\n\n* RTIs different from a lower RTI or acute rhinosinusitis\n* Patients with suspected septicemia (quick Quick Sequential Organ Failure Assessment: respiratory rate ≥22 breaths\u002Fminute, systolic blood pressure \\\u003C100 mm Hg or altered mental status with a Glasgow score \\\u003C 5) ≥2\n* Patients with pneumonia and \\[Confusion, respiratory rate ≥30 breaths\u002Fminute, blood pressure \\\u003C 90\u002F60 mm Hg, or age \\>65 yr.\\] ≥1\n* Patients with very severe COPD (Forced Expiratory Volume in One Second \\\u003C30%)\n* Patients with COPD who have taken four or more antibiotic courses in the previous year, presence of significant bronchiectasis, and\u002For isolation of Pseudomonas in a previous sputum culture\n* Patients with reported allergy to beta-lactams\n* Patients who have taken an antibiotic in the previous two weeks\n* Patients who have been hospitalized in the last two weeks\n* A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, esophageal reflux\n* Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids\n* Currently participating in another clinical trial\n* Previously participated in the STORM study\n* Active neoplasia\n* Terminal illness\n* Institutionalized patient\n* Inability\u002Funable to understand and\u002For take part in the clinical trial","75 Years",{"count":256,"type":19},474,[258],"PHASE4","The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as completing the prescribed course for acute respiratory tract infections (RTIs). The investigators will enroll 474 outpatients aged 18-75 with acute RTIs across 25 Spanish healthcare centers. Patients will be randomized into two groups: one following standard full-course antibiotic therapy, and another receiving a tailored approach, where treatment may be shortened based on clinical assessments. The primary outcome is clinical efficacy at day 14. Secondary outcomes include antibiotic duration, complications, and quality of life.",[261],"Acute Respiratory Tract Infection",[263,264,265,266,267,268,269],"Antibacterial Agents Antimicrobial Resistance","Duration","Primary Health Care","Personalized Medicine","Drugs, Customized","Drug Resistance, Microbial","Patient-Centered Care","2024-08-30",{"date":272,"type":35},"2024-09-03",{"date":274,"type":19},"2025-10-01",{"date":276,"type":19},"2027-04-30",{"name":41,"class":42},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":15,"minAge":148,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":20,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100554440","phase-4-comparison-of-the-effectiveness-of-first-line-preventive-treatment-of-migraine-in-primary-care-100554440","NCT06499116","Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care","Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]","PREMI","Inclusion Criteria:\n\n\\- Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial.\n\nExclusion Criteria:\n\n* People diagnosed with migraine who are not candidates for preventive migraine treatment\n* People diagnosed with chronic migraine (\\>15 days of headache per month, of which 8 are monthly migraine days)\n* Not having a smartphone\n* Simultaneous participation in another clinical trial\n* Pregnancy or expected pregnancy during the next 3 months\n* Lactation\n* People with migraine who already receive preventive treatment.\n* People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis.\n* People who, in the opinion of the clinician, have an absolute contraindication to one of the study drugs or who cannot perform the trial procedures:\n\nHypersensitivity to any of the study drugs \u002F Heart block or severe bradycardia \u002F Concomitant treatment with verapamil or diltiazem \u002F Active cardiovascular pathology (recent heart attack, angina, Raynaud's phenomenon) \u002F Major depression or active treatment with antidepressants (including monoamine oxidase inhibitors and St. John's wort) \u002F Other psychiatric illnesses or active treatment with antipsychotics or lithium \u002F Severe liver disease or kidney failure \u002F Parkinson's disease or other extrapyramidal disorders \u002F Epilepsy (diagnosis and\u002For active treatment) \u002F Any other contraindication that, in the opinion of the clinician, prevents participation in the clinical trial",{"count":287,"type":19},460,[258],"This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.",[291],"Migraine",[291,293,294,76],"Monthly Migraine Days (MMD)","Preventive treatment","2024-07-08",{"date":297,"type":35},"2024-07-12",{"date":299,"type":19},"2024-10",{"date":301,"type":19},"2026-12",{"name":41,"class":42},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":15,"minAge":148,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100538750","crp-and-lung-ultrasound-in-respiratory-evaluation-100538750","NCT06294899","CRP and Lung Ultrasound in Respiratory Evaluation","Evaluation of Point-of-Care Ultrasound Along With C-Reactive Protein-Point of Care Tests Impact on Clinical Decision-making and Perceived Usefulness in Routine Healthcare Use in Patients With Lower Respiratory Tract Infection. Correlation Between C-Reactive Protein Concentrations and Lung Ultrasound Findings.","PLURE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Clinical suspicion of LRTI defined as acute illness lasting less than 21 days, with cough as the main symptom, accompanied by at least one other lower respiratory symptom (such as sputum production, dyspnoea, difficult breathing, or chest pain) without any other explanation for the clinical picture.\n* Ability to read, understand and willingness to give written consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have been treated with antibiotics during the last 14 days up to inclusion.\n* Patients with hemodynamic instability or that need emergency medical care due to the current clinical condition.\n* Previous diagnosis of lung or pleural cancer.\n* Thoracic surgery within the past 60 days.\n* Lung interstitial diseases.\n* Patients who refuse to participate in the study",{"count":312,"type":19},202,"Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.\n\nThis study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.",[265,315],"Lower Respiratory Tract Infection",[317,318,319],"C-Reactive Protein","Lung ultrasonography","Lower Respiratory Tract Infections","2024-04-29",{"date":322,"type":35},"2024-04-30",{"date":324,"type":19},"2024-06-01",{"date":326,"type":19},"2028-09-01",{"name":41,"class":42},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":15,"minAge":336,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":20,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":43},"100507242","new-cardiovascular-risk-screening-strategy-100507242","NCT05884840","New Cardiovascular Risk Screening Strategy.","Health Program for prEvention of cardiovascuLar disEases Based on a Risk screeNing Strategy With Ankle-brachial Index.","HELENA","Inclusion Criteria:\n\n* Patients aged 50 to 74, which are free or do not have previous history of CVD. Patients that hold a REGICOR CV risk score ≥7, and REASON risk core ≥7, during a routine primary care visit\n\nExclusion Criteria:\n\n* Symptomatic PAD\n* Coronary disease\n* Stroke\n* Cardiac revascularization","50 Years","74 Years",{"count":339,"type":19},54000,[22],"Mortality due to cardiovascular disease (CVD) in Spain accounted for 29% of all deaths (32% in women and 26% in men) in 2017. Out of those, 67% were related to a coronary or a cerebrovascular disease .\n\nA key strategy in primary prevention of CVD is to use risk functions to individualize preventive interventions for each patient. The current CV risk-screening program in some regions of Spain, is based using an adapted Framingham scale, REGICOR's risk function, which is integrated in the primary care electronic health record. This risk function predicts the probability within 10 years of developing a coronary event. However, this function fails to identify patients that fall into low- or intermediate-risk level, and might develop a CV event in the up following 10 years.\n\nAnkle-brachial index (ABI) is a simple, non-invasive and economic technique, which allows detecting peripheral arterial disease (PAD), and gives independent risk function information compared to other coronary risk functions. Even tough, between 13-27% of middle age population have an ABI ≤ 9, around 50-89% of them do not exhibit any symptoms. However, they hold higher mortality risk and CV events. Current clinical guidelines for PAD screening, have a limited level of evidence, and only recommend using ABI on patients aged 50-70, who have diabetes or are smokers, and patients older than 70 years old.\n\nA new risk function, REASON, to assess CVD risk has been designed. This model has proven to improve predictive capacity of holding an ABI ≤ 0.9 on those patients aged 50-74 that are apparently free of CVD. Therefore, a strategy that combines the current CV risk estimation using REGICOR, and the prediction capacity of pathologic ABI with REASON, would allow detecting high-risk patients with a PAD screening program. It is possible that patients, who hold an ABI ≤ 0.9, even if being asymptomatic, will adopt physician's recommendations on healthy life habits and preventive treatment.\n\nThe aims of this study are:\n\n* To assess the effectiveness and cost-utility of adding a screening program with ABI to the current strategy of CV risk detection to reduce the incidence of CVD and mortality from all causes in the population aged 50 to 74.\n* To assess the effectiveness of adding a screening program with ABI to the current strategy of CV risk detection to improve cardiovascular risk factors in the population aged 50 to 74.",[343,344,345,346,347],"Cardiovascular Prevention","Screening","Peripheral Artery Disease","Arteriosclerosis","Asymptomatic","2023-12-22",{"date":350,"type":35},"2023-12-29",{"date":352,"type":35},"2023-11-20",{"date":354,"type":19},"2026-06",{"name":41,"class":42},""]