[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universidade do Porto\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":693},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,52,77,106,136,163,193,226,252,287,307,335,359,382,412,438,461,483,509,528,557,583,602,628,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100628135","mygenesis-path-a-pilot-and-feasibility-trial-of-a-digital-intervention-for-donor-conceived-adults-100628135",false,"NCT07457697","MyGENESIS-PATH: A Pilot and Feasibility Trial of a Digital Intervention for Donor-Conceived Adults","A Randomized Pilot and Feasibility Trial of MyGENESIS-PATH, a Digital Psychoeducational Intervention for Donor-Conceived Adults","MyGENESIS-Path","Inclusion Criteria:\n\n* Donor-conceived people\n* Aged 18 or over\n* Able to read and understand English\n* Provide informed consent\n\nExclusion Criteria:\n\n* Not donor-conceived\n* Underaged ot minor\n* Unable to read and understand English\n* Unable to provide informed consent\n* Inability to complete online questionnaires \u002F lack of internet access",true,"ALL","18 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"NA","MyGENESIS-PATH is a self-guided digital psychoeducational intervention designed to support donor-conceived adults in managing stress and navigating identity, information, family, DNA-testing, and donor- or sibling-contact-related experiences.\n\nThis randomized pilot and feasibility trial will evaluate the feasibility and acceptability of delivering MyGENESIS-PATH and of conducting a future definitive randomized controlled trial. Sixty donor-conceived adults will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control group. The primary objectives are to assess recruitment, retention, intervention uptake and completion, data completeness, acceptability, usability, and potential unwanted effects. Changes in perceived stress, psychological wellbeing, coping, and donor-conception-related identity will be explored to assess the suitability and variability of outcome measures and to inform the design of a future trial.",[29],"Psychosocial Stress",[31,32,33,34,35,36,37,38],"donor-conceived people","donor conception","Psychoeducational intervention","Digital intervention","Cognitive-behavioral training","Stress and coping","Psychological well-being","Randomized controlled trial","NOT_YET_RECRUITING","2026-06-18",{"date":42,"type":43},"2026-06-24","ACTUAL",{"date":45,"type":23},"2026-07-01",{"date":47,"type":23},"2026-10-31",{"name":49,"class":50},"Universidade do Porto","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":51},"100641266","psychodrama-group-therapy-for-breakup-distress-and-relationship-adjustment-a-randomized-trial-100641266","NCT07658248","Psychodrama Group Therapy for Breakup Distress and Relationship Adjustment: A Randomized Trial","Psychodrama Group Therapy for Unresolved Breakup Distress and Dyadic Adjustment in Current Romantic Relationships: Study Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older;\n* Currently involved in a romantic relationship for at least 6 months;\n* History of at least one significant previous romantic relationship breakup;\n* Presence of breakup distress related to a previous romantic breakup and\u002For difficulties in current dyadic adjustment;\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of severe mental disorder that may interfere with participation in group psychotherapy;\n* Severe active substance dependence;\n* Current severe relational violence;\n* Inability or unwillingness to provide written informed consent;\n* Any clinical condition that, in the opinion of the research team, may compromise safe participation in the intervention.",{"count":60,"type":23},42,[26],"The purpose of this randomized controlled trial is to evaluate whether a psychodrama group therapy intervention can reduce unresolved breakup distress and improve dyadic adjustment in adults currently involved in romantic relationships who have experienced a significant previous breakup.\n\nThe main questions this study aims to answer are:\n\n* Does participation in psychodrama group therapy reduce breakup distress compared with a waiting-list control condition?\n* Does participation in psychodrama group therapy improve dyadic adjustment and relationship functioning compared with a waiting-list control condition?\n\nThe researchers will compare participants receiving the psychodrama group therapy intervention with participants in a waiting-list control condition to determine whether the intervention leads to greater improvements in breakup distress, dyadic adjustment, psychological functioning, relationship quality, and sexual satisfaction.\n\nParticipants will:\n\n* complete assessments at baseline, 16 weeks, and 42 weeks;\n* participate in a 15-session weekly psychodrama group therapy program (intervention group only);\n* complete questionnaires assessing breakup distress, dyadic adjustment, psychological outcomes, relationship quality, and sexual satisfaction.",[64,65],"Breakup Distress","Dyadic Adjustment",[67,64,65,68],"Psychodrama","group psychotherapy","RECRUITING","2026-06-14",{"date":40,"type":43},{"date":73,"type":43},"2025-09-23",{"date":75,"type":23},"2027-05",{"name":49,"class":50},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":51},"100640320","tiva-mobile-health-intervention-for-family-caregivers-100640320","NCT07616284","TIVA Mobile Health Intervention for Family Caregivers","A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study","TIVA-Pilot","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Unpaid family caregivers of a person with chronic illness, disability, or dependency.\n* Providing regular caregiving assistance for at least 4 months.\n* Living in Portugal.\n* Ability to read and understand Portuguese.\n* Ownership and use of a smartphone with internet access compatible with the TIVA mobile application.\n* Willingness to install and use the TIVA app for 4 weeks.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment.\n* difficulties preventing independent use of the application or completion of study assessments.\n* Severe psychiatric disorder or acute mental health crisis interfering with participation.\n* Participation in another structured caregiver support or psychological intervention during the study period.\n* Inability to use a smartphone independently.",{"count":86,"type":23},80,[26],"This pilot study aims to evaluate the feasibility, usability, and preliminary effects of the TIVA mobile health intervention in promoting positive mental health among family caregivers of older adults. TIVA is a culturally adapted mobile application based on Lluch's Positive Mental Health model and designed to support caregivers through daily activities, motivational messages, relaxation strategies, and psychoeducational content over a four-week intervention period.\n\nA pilot randomized controlled study with parallel allocation will be conducted involving family caregivers recruited in community and primary healthcare settings in Portugal. Participants will be allocated either to the TIVA intervention group or to a usual care control group. Outcomes will include positive mental health, caregiver burden, usability, satisfaction, adherence, and acceptability. Data will be collected at baseline, post-intervention, and follow-up.\n\nThis study intends to contribute to the development of accessible digital mental health strategies to support family caregivers and promote healthy ageing.",[90,91,92,93],"Positive Mental Health","Family Caregivers","Mental Health Promotion","Caregiver Burden",[95,91,90,96,92,97,93],"TIVA mHealth","Older Adults","Mobile Application","2026-05-29",{"date":100,"type":43},"2026-06-01",{"date":102,"type":23},"2026-09",{"date":104,"type":23},"2027-04",{"name":49,"class":50},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":24,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":51},"100631275","immediate-restoration-of-a-new-implant-with-high-primary-stability-100631275","NCT07498556","Immediate Restoration of a New Implant With High Primary Stability","Immediate Restoration of a New Implant With High Primary Stability: A 1-year Follow-up - Clinical Study","CT","Inclusion Criteria:\n\n* Men and women between 18 and 70 years of age.\n* Ability to read, understand, and sign the informed consent form.\n* Need for placement of one or more implants for fixed prosthetic rehabilitation in either arch.\n* Insertion torque ≥ 35 Ncm (lower values will be excluded from the study).\n* Adequate bone dimensions to receive an implant with diameter ≥ 3.75 mm and length ≥ 10 mm.\n* Bone type I to III at the insertion site.\n* Good oral hygiene: FMBS and FMPS ≤ 25%.\n* Systemic status classified as ASA I or II.\n\nExclusion Criteria:\n\n* Inability to attend follow-up appointments.\n* Systemic contraindications to oral surgery (ASA III or IV).\n* Pregnancy or breastfeeding.\n* Chronic use of corticosteroids, bisphosphonates, or RANKL inhibitors within the last year.\n* Alcohol or drug abuse.\n* Heavy smoking (≥ 10 cigarettes\u002Fday).\n* Previous radiotherapy in the cervicofacial region.\n* Untreated active periodontal disease.\n* Absence of antagonist teeth.\n* Local pathology at the planned implant site.\n* Uncontrolled diabetes mellitus (HbA1c \\> 7%).\n* Bone type IV at the surgical site.","70 Years",{"count":116,"type":23},50,[26],"The main objective of this scientific study is to evaluate the short-term (1-year) survival and success rates of dental implants restored immediately compared to implants restored after a three-month healing period.\n\nThe total duration of the study is 12 months following implant placement, during which clinical and radiographic evaluations will be carried out at different follow-up time points.",[120,121],"Dental Implants","Immediate Dental Implant Loading",[123,124,125,126,127,128],"dental implants","Immediate loading","Delayed loading","Implant survival rate","Marginal bone loss","Esthetic outcome evaluation","2026-04-28",{"date":131,"type":43},"2026-05-05",{"date":45,"type":23},{"date":134,"type":23},"2027-12-30",{"name":49,"class":50},{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":51},"100633642","study-of-hyaluronic-acid-used-with-gum-surgery-to-treat-gum-recession-in-adults-100633642","NCT07529340","Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults","Effectiveness of Hyaluronic Acid Application in Coronally Advanced Flap Combined With a Subepithelial Connective Tissue Graft Versus Coronally Advanced Flap Combined With a Subepithelial Connective Tissue Graft Alone: A Clinical Trial","Inclusion Criteria:\n\n* \\- Age ≥ 18 years, in good general health (ASA I or II)\n* Presence of a single gingival recession defect classified as RT1 or RT2\n* Recession depth ≥ 2 mm with identifiable cemento-enamel junction (CEJ)\n* Presence of at least 1 mm of keratinized tissue at the defect site\n* No active periodontal disease (probing depth ≤ 4 mm and no bleeding on probing at the selected tooth)\n* Full-Mouth Plaque Score (FMPS ≤ 20%) and Full-Mouth Bleeding Score (FMBS ≤ 20%)\n* Vital tooth without caries, cervical lesions, or defective restorations\n* Good oral hygiene and motivation to maintain plaque control\n* Ability and willingness to comply with study procedures\n* Signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular disease, immunodeficiency)\n* Pregnant or breastfeeding women\n* Autoimmune diseases or immunosuppressive therapy\n* Known hypersensitivity to hyaluronic acid\n* Heavy smokers (\\>10 cigarettes\u002Fday) or recent tobacco use\n* Active periodontal disease at the study site\n* Caries, root fractures, endodontic lesions, or defective restorations at the study tooth\n* Previous mucogingival surgery at the study site\n* Recent use of antibiotics, corticosteroids, or anti-inflammatory drugs\n* Coagulation disorders or anticoagulant therapy contraindicating surgery\n* Hormonal disorders affecting wound healing\n* Acute oral infections\n* Any condition that may interfere with study participation or follow-up",{"count":144,"type":23},34,[26],"Gingival recession is a common condition in which the gum tissue recedes, exposing the root surface of the tooth. This can lead to tooth sensitivity, higher risk of root decay, and aesthetic concerns. A commonly used surgical treatment is the coronally advanced flap combined with a connective tissue graft (CAF + SCTG), which aims to cover the exposed root and improve gum health.\n\nHyaluronic acid (HA) is a naturally occurring substance in the body that plays an important role in wound healing. It may help improve tissue repair, reduce inflammation, and enhance healing after surgery.\n\nThis study aims to evaluate whether the use of hyaluronic acid (hyaDENT BG®) in addition to standard surgical treatment improves clinical outcomes in patients with gingival recession. Participants will be randomly assigned to receive either standard treatment alone or standard treatment with hyaluronic acid.\n\nThe main outcome is the proportion of sites with complete root coverage after 12 months. Additional outcomes include healing, gum tissue improvement, patient-reported pain and discomfort, and aesthetic results.\n\nThe study also includes a laboratory component to investigate how hyaluronic acid affects cells involved in gum healing.",[148],"Gingival Recession, Mucogingival Surgery",[150,151,152,153,154],"Gingival recession","Coronally advanced flap","Connective tissue graft","Hyaluronic acid","Mucogingival surgery","2026-04-14",{"date":157,"type":43},"2026-04-20",{"date":159,"type":23},"2026-05",{"date":161,"type":23},"2027-09",{"name":49,"class":50},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":18,"sex":19,"minAge":171,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":173,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":51},"100623154","multicomponent-exercise-program-on-physical-function-cognition-and-falls-risk-among-older-adults-living-in-nursing-homes-move4care-100623154","NCT07392944","Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes (MOVE4CARE)","Effects of a Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes: MOVE4CARE","MOVE4CARE","Inclusion Criteria:\n\n* Ability to ambulate (with or without assistance);\n* Ability to perform chair stands (with or without assistance);\n* Ability to understand and properly follow testing procedures.\n\nExclusion Criteria:\n\n* Any contraindication that precludes exercise performance or testing procedures, including terminal illness, uncontrolled disease, or other unstable medical conditions;\n* Short Physical Performance Battery (SPPB) score \\\u003C 3 points;\n* Participation in any exercise intervention within the past 3 months;\n* Simultaneous participation in another clinical trial during the study;\n* Planned transfer to another nursing home facility, to home, or to hospitalization during the intervention.","65 Years",{"count":22,"type":23},[26],"Can a multicomponent exercise program significantly improve physical and cognitive function and reduce fall rates among nursing home residents? To address this question, the present study aims to compare the effectiveness of a multicomponent exercise program with a stretching and relaxation program in nursing home residents.",[176,177],"Frailty","Dementia",[179,176,180,181,182,183,184],"Exercise","Nursing homes","Multicomponent exercise","Falls","Cognitive function","Physical performance","2026-02-11",{"date":187,"type":43},"2026-02-17",{"date":189,"type":23},"2026-02-18",{"date":191,"type":23},"2026-07-31",{"name":49,"class":50},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":203,"conditions":204,"keywords":211,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":51},"100622166","suprascapular-nerve-block-to-improve-tolerance-and-outcomes-of-shoulder-hydrodistension-in-adhesive-capsulitis-100622166","NCT07380087","Suprascapular Nerve Block to Improve Tolerance and Outcomes of Shoulder Hydrodistension in Adhesive Capsulitis","Efficacy of Suprascapular Nerve Block on the Tolerability and Effectiveness of Shoulder Hydrodistension in Patients With Adhesive Capsulitis: A Randomized Clinical Trial","SHINE","Inclusion Criteria\n\n* Adults aged 18 years or older\n* Clinical diagnosis of adhesive capsulitis of the shoulder\n* Persistent pain and functional limitation despite initial conservative treatment\n* Ability to understand study procedures\n* Ability to provide written informed consent\n\nExclusion Criteria\n\n* Known allergy or hypersensitivity to ropivacaine or methylprednisolone\n* Active infection (local or systemic)\n* Uncontrolled coagulopathy or ongoing therapeutic anticoagulation\n* Recent surgery of the affected shoulder\n* Neurological disease affecting the upper limb\n* Pregnancy",{"count":116,"type":23},[26],"Adhesive capsulitis (\"frozen shoulder\") causes significant pain and loss of shoulder mobility. Shoulder hydrodistension is an established treatment that can improve movement and reduce symptoms, but the procedure itself may be painful and difficult for some patients to tolerate.\n\nThis randomized clinical trial will evaluate whether performing a suprascapular nerve block with local anesthetic immediately before hydrodistension can reduce pain during the procedure, improve patient comfort, and potentially enhance clinical outcomes.\n\nParticipants will be randomly assigned to one of two groups:\n\nhydrodistension alone, or\n\nsuprascapular nerve block followed by hydrodistension.\n\nPain, shoulder mobility, functional ability, psychological measures, and quality of life will be assessed at baseline, 1 month, and 3 months after the procedure. The study aims to determine whether adding a suprascapular nerve block provides better tolerability and improved recovery for patients with adhesive capsulitis.",[205,206,207,208,209,210],"Adhesive Capsulitis","Adhesive Capsulitis of Unspecified Shoulder","Adhesive Capsulitis, Shoulder","Frozen Shoulder","Shoulder Pain","Shoulder Stiffness",[212,213,209,214,215,216,217],"Shoulder Hydrodistension","Suprascapular Nerve Block","Shoulder Mobility","Randomized Clinical Trial","Pain Management","Rehabilitation","2026-01-26",{"date":220,"type":43},"2026-02-02",{"date":222,"type":23},"2026-03-01",{"date":224,"type":23},"2028-07-31",{"name":49,"class":50},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":24,"phases":235,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":251},"100619616","evaluating-the-impact-of-in-situ-simulation-on-interprofessional-healthcare-team-training-100619616","NCT07346937","Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training","Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training: A Randomized Trial","Inclusion Criteria:\n\n* Professionals working in the surgical center of ULSM-HPH with at least 6 months of experience in the role.\n* Availability to participate in the simulation group assigned to them.\n\nExclusion Criteria:\n\n* Professionals who do not work in the surgical center.\n* Participants who cannot complete all phases of the study due to scheduling or health restrictions.\n* Pregnant professionals.",{"count":234,"type":23},108,[26],"Clinical simulation has established itself as an essential methodology in healthcare training, enabling the development of technical and non-technical skills in controlled and safe environments. This study proposes a randomized trial that compares the impact of two learning contexts-a simulation center and the in situ simulation (ISS) environment in the operating room-on the training of interprofessional teams. The aim is to evaluate the effectiveness and efficiency of each context in the acquisition and performance of technical and non-technical skills, as well as participants' perceptions of realism, teamwork, and patient safety. The randomized experimental design reinforces the methodological rigor and internal validity of the results, allowing the identification of important differences between the two approaches. The scarcity of studies on interprofessional simulation in a real clinical context underscores the relevance of this research, which may provide scientific evidence to guide training policies and promote safer, more collaborative practices. It is expected that the results will contribute to improving interprofessional training programs and supporting the systematic integration of ISS in the healthcare field, especially in high-complexity environments.",[238,239],"in Situ Simulation","Simulation in Training Center",[241,242,243],"In Situ Simulation","Simulation Center","Interprofessional Team Training","2026-01-07",{"date":246,"type":43},"2026-01-16",{"date":248,"type":23},"2026-02",{"date":191,"type":23},{"name":49,"class":50},2,{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":19,"minAge":260,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":24,"phases":263,"briefSummary":264,"conditions":265,"keywords":273,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":51},"100606246","algae-effects-in-markers-of-cardiovascular-risk-and-gut-microbiome-100606246","NCT07173062","Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome","Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome: a Placebo-controlled Randomized Double-blind Trial","CALGUT","Inclusion Criteria:\n\n* ≥50 years\n* BMI ≥20 kg\u002Fm2\n* History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR \\\u003C75 ml\u002Fmin at least for 3 months), albuminuria \\>300 mg\u002Fg, or diabetes mellitus\n* No antibiotics in the previous 30 days\n* If a woman, she must be a woman of non-childbearing potential. That is, she must be:\n\n  * Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy);\n  * Clinically diagnosed infertile;\n  * In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.\n* A woman patient of childbearing potential must have a negative serum pregnancy test at Visit 0 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:\n\n  * Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject);\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);\n  * Intrauterine device;\n  * Intrauterine hormone-releasing system;\n  * Bilateral tubal occlusion;\n  * Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.\n\nExclusion Criteria:\n\n* Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign\u002Fcomplete the informed consent form on the patient's behalf).\n* Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n* Participation in another clinical study with an investigational product during the last month.\n* In participants recruited at Unidade Local de Saúde de São João, the exclusion criteria applied is estimated Glomerular Filtration Rate (eGFR) \\\u003C30 ml\u002Fmin\u002F1.73m2 estimated with the CKD-EPI (2021) formula or dialysis. For participants recruited at community, this exclusion criteria is adapted for diagnosis of end-stage renal disease or dialysis (no need to quantify the eGFR).","50 Years",{"count":262,"type":23},150,[26],"The Western diet, rich in fat and sugar, contributes to cardiovascular risk and alters the body metabolism, specifically through the modulation of the microbiome. Microbiome is considered the \"second genome\", functioning as an endocrine-like organ. Gut microbiota-derived metabolites, namely trimethylamine- N-oxide and short-chain fatty acids have been associated with atherosclerosis, vascular and cardiac diseases. Regarding trimethylamine- N-oxide, its association with cardiovascular disease is positive and dose-dependent. In contrast, short-chain fatty acids have been positively associated with the improvement of cardiovascular health.\n\nAlgae probiotics can modulate gut microbiome, stimulating the growth of commensal micro-organisms with health benefits. Previous studies suggested that Spirulina Arthrospira platensis supplementation could improve blood lipid levels and lower blood pressure, revealing anti-inflammatory and antioxidant roles. Other probiotics that could be beneficial to gut microbiota are macroalgae or seaweed. Macroalgae are a rich source of components which may prompt bacterial diversity and abundance.\n\nThe present prospective, randomized, three-armed parallel trial aims to generate good-quality evidence about the potential health effects and impact of Spirulina Arthrospira platensis (microalgae) and Gelidium corneum (macroalgae) supplements in humans. These participants will undergo 3 clinical evaluations: 2 before the beginning of micro- and macro-algae supplementation and the last one after 20 weeks of supplementation. The evaluation includes a vascular, nutritional and physical activity assessment, as well as blood, urine, saliva and stool collection for quantification of plasma biomarkers, oral and gut microbiota analysis, respectively.",[266,267,268,269,270,271,272],"Stroke","Coronary Arterial Disease (CAD)","Myocardial Infarction (MI)","Diabetes Mellitus","Peripheral Artery Disease (PAD)","Chronic Kidney Disease(CKD)","Albuminuria",[274,275,276,277,278],"Spirulina Arthrospira platensis","Gelidium corneum","Trimethylamine- N-oxide (TMAO)","Short-Chain Fatty Acids (SCFA)","Cardiovascular risk (CVR)","2025-09-12",{"date":281,"type":43},"2025-09-15",{"date":283,"type":43},"2025-03-11",{"date":285,"type":23},"2026-08",{"name":49,"class":50},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":24,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100599199","laparo-analytic-vs-classic-box-trainer-on-laparoscopic-skills-training-100599199","NCT07081386","LAPARO Analytic vs. Classic Box Trainer on Laparoscopic Skills Training","LAPARO Analytic vs. Classic Box Trainer: A Randomized Trial on Appendicectomy Laparoscopic Skills Training","Inclusion Criteria:\n\n* First-year medical residents (internos de ano comum) currently enrolled at Centro Hospitalar Universitário de São João (CHUSJ).\n* Voluntary participation confirmed by completion of an informed consent and online registration form.\n* Availability to participate in both the initial training session and the follow-up cadaveric assessment 15 days later.\n\nExclusion Criteria:\n\n* Any prior exposure to laparoscopic surgical techniques formal training.\n* Engagement in any laparoscopic training activities between the recruitment date and the practical evaluation session.\n* Inability to attend either the scheduled training or the cadaveric assessment session.",{"count":22,"type":23},[26],"This randomized controlled trial investigates the effectiveness of two laparoscopic training modalities - Classic Box Trainers and the LAPARO Analytic - in teaching fundamental surgical skills for laparoscopic appendicectomy. A total of 60 first-year medical residents (interns) from Centro Hospitalar Universitário de São João (CHUSJ) will be recruited and randomly assigned to one of two training groups. One group will undergo a 3-hour in-person training session using Classic Box Trainers, while the other group will train using the LAPARO Analytic simulator, both under the supervision of experienced General Surgery tutors. The study aims to evaluate technical skill acquisition, retention, and participant satisfaction. Outcomes will be assessed through objective performance metrics and participant feedback, contributing to the optimization of laparoscopic education methods.",[298],"Laparoscopic Surgical Training","2025-07-25",{"date":301,"type":43},"2025-07-30",{"date":303,"type":23},"2025-08",{"date":305,"type":23},"2025-12",{"name":49,"class":50},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":315,"minAge":20,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":51},"100595917","mediterranean-diet-intervention-for-maternal-postpartum-100595917","NCT07038681","Mediterranean Diet Intervention for Maternal Postpartum","Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial","MedMom","Inclusion Criteria:\n\n* Adult female (\\>18 years old)\n* Obesity\n* Chronic arterial hypertension\n* Type 2 diabetes\n* Gestational hypertension\n* Gestational diabetes\n\nExclusion Criteria:\n\n* Preexisting cardiomyopathy;\n* Renal disease;\n* Chronic obstructive airway disease;\n* Active systemic infection;\n* Genetic syndromes;\n* Type 1 Diabetes mellitus","FEMALE",{"count":317,"type":23},52,[26],"The increasing prevalence of obesity during women's reproductive years highlights the need for effective strategies to improve nutritional literacy as a preventive approach to adverse postnatal outcomes.\n\nThis study outlines a protocol for a pilot randomized controlled trial assessing the potential of nutritional education sessions promoting the Mediterranean Diet (MedDiet) to improve adherence to this diet and evaluate its effects on cardiometabolic outcomes, namely on cardiac reverse remodeling, glycemic and blood pressure control, as well as on preconception weight recovery and changes in the fecal microbiota composition in pregnant women with obesity, hypertension, and\u002For diabetes.\n\nSecondarily, this study aims to evaluate how this dietary intervention indirectly interferes with infants' exclusive breastfeeding and the introduction of complementary feeding. It includes a face-to-face session using an eye-catching 13-page manual, followed by five monthly newsletters sent by e-mail. Participants will be monitored at one, six, and twelve months postpartum to evaluate the intervention's effectiveness. Findings from this study will contribute to the development of an evidence-based nutritional education tool designed to improve maternal health outcomes, with potential applicability for both health professionals and pregnant and postpartum women.",[321,322,323],"Postpartum","Cardiometabolic Factors","Cardiac Reverse Remodeling",[325,321,326,323],"Mediterranean Diet","Pregnancy","2025-06-17",{"date":329,"type":43},"2025-06-26",{"date":331,"type":43},"2025-05-31",{"date":333,"type":23},"2025-12-31",{"name":49,"class":50},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":19,"minAge":343,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":24,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":51},"100473682","molecular-allergen-component-resolved-diagnosis-to-decide-immunotherapy-100473682","NCT05448066","Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy","Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial","CRD-AIT","Inclusion Criteria:\n\n* Individuals with medical indication for aeroallergen immunotherapy(AIT) for allergic rhinoconjunctivitis or asthma, accordingly to the AIT guidelines;\n* Over 5 years of age;\n* Evidence of IgE-sensitization (positive skin prick tests and \u002F or serum specific-IgE)\n* Patients have indication to AIT to house dust mites and\u002For grass pollen, association with other allergens is not an exclusion criteria\n\nExclusion Criteria:\n\n* Previously performed allergen immunotherapy\n* Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy","5 Years",{"count":345,"type":23},210,[26],"Allergen immunotherapy (AIT) is used for the control of allergic diseases that are not completely responsive to avoidance strategies and\u002For pharmacotherapy. It is also considered the main treatment with the potential to modify allergic disease evolution. It's efficacy and safety in allergic rhinitis and asthma is supported by large systematic reviews and is recommended as a cornerstone treatment option in allergic disease. Molecular based allergy diagnosis has greatly evolved and the knowledge of molecular allergen sensitization pattern has been used to better define the allergen extract composition of AIT. However, uncertainty remains if this strategy is related to an increase of efficacy. Regulation of allergen extracts for allergen immunotherapy are currently underway in Europe, but there is still lack of standardization of relevant allergens and important differences are seen between allergenic contents.\n\nTherefore, we aim to evaluate, in a real-life setting, the impact of using molecular-based diagnosis versus standard diagnostic tools in the efficacy of aeroallergen immunotherapy, using a pragmatic randomized controlled trial design and also to address the impact of the discrepancy between individual aeroallergen sensitization profiles and the major allergen molecular content of aeroallergen immunotherapy.",[349,350],"Asthma","Rhinitis, Allergic","2025-04-02",{"date":353,"type":43},"2025-04-06",{"date":355,"type":43},"2022-07-30",{"date":357,"type":23},"2026-06-30",{"name":49,"class":50},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":315,"minAge":4,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":367,"phases":4,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":51},"100585635","determinants-of-the-nutritional-composition-of-donor-human-milk-100585635","NCT06904924","Determinants of the Nutritional Composition of Donor Human Milk","Study of Determinants of the Nutritional Composition of Donor Human Milk","Inclusion Criteria:\n\n* Human milk donors at BLHN\n* Informed consent of the participant\n\nExclusion Criteria:\n\n* None",{"count":86,"type":23},"OBSERVATIONAL","Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment. In special circumstances, such as prematurity or illness, breast milk is not always available, and donor human milk (DHM) is an option. Some studies have reported growth retardation in babies fed DHM, probably due to the less adequate nutritional composition. There are several factors that contribute to changes in its nutritional composition. Among the various factors, the following are worth highlighting: wide variety of donors with different characteristics (e.g. gestational age, lactation phase, diet); inconsistency of the collection method; impact of milk processing, i.e. the pasteurization process.\n\nAs the Human Milk Bank of North (BLHN - Banco de Leite Humano do Norte) is the first in the North region of Portugal, and there are few studies developed in this area in Portugal, the present project aims to study the influence of the following factors on the composition of the DHM:\n\n* Pasteurization process;\n* Dietary habits of donors;\n* Body composition of donors.",[370],"Human Milk Nutrition",[372,373],"Donor human milk","Human milk nutrition","2025-03-24",{"date":376,"type":43},"2025-04-01",{"date":378,"type":23},"2025-05",{"date":380,"type":23},"2028-06",{"name":49,"class":50},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":18,"sex":19,"minAge":390,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":24,"phases":394,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":51},"100579381","phase-1-investigation-of-the-mechanisms-of-the-gut-brain-axis-in-binge-eating-and-obesity-100579381","NCT06823557","Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity.","Gut2Brain: Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity","Gut2Brain","Inclusion Criteria:\n\n* Portuguese adults (25 with normal weight; 25 with obesity only (30 ≤ BMI \\\u003C 40) and BED; 54 with BED)\n* Residents in Portugal for the past 10 years\n\nExclusion Criteria:\n\n* Significant weight loss (\\>5% of body weight) in the past 2 years\n* Antibiotic use in the past 6 months\n* History of surgery or medical\u002Fpsychiatric diseases\n* Pregnant or breastfeeding\n* History of drug use or dependence\n* Use of medications that impact weight\n* Have metal implants or pacemakers","20 Years","45 Years",{"count":393,"type":23},104,[395],"PHASE1","Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity.\n\nThe goal of this randomized clinical trial (RCT) is to investigate the role of psychobiotics in modulating the gut-brain axis and improving binge eating in adults, with a particular focus on evaluating these effects independently of obesity status. This project stands out for its comprehensive approach to understanding BED, integrating psychological, neurofunctional, hormonal, and microbiota factors that contribute to this complex disorder.\n\nThe main questions it aims to answer are:\n\n* What specific alterations in the MGBA pathways are associated with BED?\n* Can psychobiotic supplementation effectively reverse microbiota alterations and modulate MGBA activity, ultimately improving BED symptoms? Researchers will compare participants receiving psychobiotics to those receiving a look-alike substance that contains no drug (a placebo) to evaluate whether psychobiotics impact endocrine hormones, neurofunction, psychological and behavioral factors related to eating regulation, and BED symptoms.\n\nParticipants will:\n\n* Undergo an assessment protocol that includes microbiota sampling, blood tests for hormone analysis, neurofunctional evaluations, and psychological\u002Fbehavioral assessments before and after the psychobiotics\u002F placebo intervention.\n* Take psychobiotics or a placebo daily for 12 weeks and receive well-being monitoring\n* Participate in follow-up visits three months after the intervention to monitor changes in BED symptoms and related parameters.",[398,399],"Binge Eating Disorder","Obesity",[401,402,403,399,404],"psychobiotic treatment","Study of neuro-psycho-biological mechanisms","Microbiota-Gut-Brain Axis (MGBA)","Binge eating disorder",{"date":406,"type":43},"2025-03-28",{"date":408,"type":23},"2025-04",{"date":410,"type":23},"2030-03",{"name":49,"class":50},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":24,"phases":422,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":51},"100584286","evaluating-the-efficacy-of-a-new-sexual-violence-prevention-program-with-college-students-100584286","NCT06887361","Evaluating the Efficacy of a New Sexual Violence Prevention Program with College Students","The Efficacy of a New Sexual Violence Prevention Program with College Students: a Randomized Controlled Trial","MOON Program","Inclusion Criteria:\n\n18 years old or older Enrolled in a Portuguese university Fluent in Portuguese (written and spoken)\n\n\\-\n\nExclusion Criteria:\n\n\\-",{"count":421,"type":23},200,[26],"This research project will develop, deliver, and assess the efficacy of a new sexual violence (SV) prevention program for college students. The MOON program (Moving ON against sexual violence) aims to prevent sexual violence amongst university students, who are known to be an at-risk population for this form of violence.\n\nThe MOON program follows a bystander approach, aiming to teach and capacitate young adults to be active agents of prevention within their communities. To do so, the program combines education on several SV-related topics with skills-training activities.\n\nThroughout five online sessions, the participants will be educated on topics such as sexual violence and consent, gender stereotypes, SV myths and bystander attitudes and behaviors. The main goal is to promote discussion forums, increase the participants knowledge on these topics and deconstruct pre-conceived beliefs\u002Fideas that promote societal tolerance and acceptance of SV The program follows a bystander approach to support young adults in the development of bystander attitudes and behaviors that will help them act in situations of risk of SV. To achieve this goal, the program sessions will also have a major focus on building bystander prevention skills through online practical exercises (e.g., training scenarios).\n\nFinally, the program also focuses on promoting empathy towards others, specifically in the context of sexual violence prevention. This focus aims to deconstruct victim blaming narratives and to build victim-support skills, to enhance the students' sense of responsibility and their proclivity to act and help others in need. Being empathic towards others is perceived as a crucial component in the bystander decision-making to intervene.\n\nThis clinical trial will apply the MOON program with university students nationwide in the Portuguese context and compare the participants who will take part in the program (experimental group) with other students who will not (control group). Thus, the RCT will be conducted with the following goals:\n\n1. To assess the treatment's efficacy, by evaluating the program's ability to significantly reduce gender stereotypes, sexism, and rape myths; and to significantly increase active bystander attitudes and behaviors and empathy towards other people.\n2. To examine the extent to which any changes are maintained three, six and nine months after the program's completion.\n3. To assess mechanisms of change, i.e., to test whether changes in cognitive outcomes, namely in rape myth endorsement, are associated with changes over time in behavioral outcomes, as bystander attitudes\u002Fbehaviors.\n4. To investigate the role of age and gender as moderators of change over time in SV perpetration, gender stereotypes, sexism, rape myths, bystander attitudes and behaviors and empathy.",[425],"Sexual Violence",[427,425,428,429,430],"Clinical trial","Prevention","College Students","Bystander Approach","2025-03-13",{"date":433,"type":43},"2025-03-20",{"date":435,"type":43},"2025-02-10",{"date":248,"type":23},{"name":49,"class":50},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":114,"enrollmentInfo":445,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":458,"leadSponsor":460,"locationsCount":51},"100581281","effectiveness-of-early-intervention-in-palliative-care-for-acute-myeloid-leukemia-patients-comparing-to-standard-of-care-100581281","NCT06848270","Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care","Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care: a Randomized Pragmatic Clinical Trial, 1:1 Ratio, Parallel Group and Superiority Study","Inclusion Criteria:\n\n* Capable of making decisions\n* Diagnosed with acute myeloid leukemia\n* Aged 70 years or less\n* Treated or referred for treatment at the Hematology department of Centro Hospitalar e Universitário de São João.\n\nExclusion Criteria:\n\n* All patients referred for \"best supportive care\", that is, for supportive care including treatment with cytoreductive intent.",{"count":116,"type":23},[26],"Hemato-oncology patients undergoing intensive chemotherapy treatments experience different types of symptoms during and after treatments, which are often refractory to the established therapy. Physical symptoms such as pain, dyspnea, mucositis, insomnia, loss of appetite, constipation and diarrhea, among others, have a huge impact on quality of life, temporarily until symptomatic control, but also permanently with the development of anxiety, depression, long-term fatigue and post-traumatic stress. As recommended by ASCO (American Society of Clinical Oncology), the palliative approach to oncological diseases must be as early as possible and be part of the \"standard of care\". However, the lack of concrete data on this topic in the last decade served as a barrier to the early integration of this same care for hemato-oncology patients in its various areas. Palliative care presupposes global, interdisciplinary action, carried out by specific teams that must act in situations of incurable or serious illness, in an advanced and progressive phase. The potential benefits can be countless and of significant importance, from the impact on quality of life, symptomatic control, reduction of anxiety and depression and even the promotion of informed and conscious choices at the end of life as well as the reduction of aggressive strategies. used at this stage of the disease.",[449,450],"Palliative Care","Acute Myeloid Leukaemia",[452,453],"Acute myeloid leukaemia","Palliative care","2025-02-21",{"date":456,"type":43},"2025-02-27",{"date":376,"type":23},{"date":459,"type":23},"2026-08-01",{"name":49,"class":50},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":18,"sex":19,"minAge":469,"maxAge":114,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":4},"100581282","randomized-controlled-trial-on-carotid-atherosclerosis-screening-in-asymptomatic-smokers-and-hypertensive-adults-prevalence-and-impact-on-cardiovascular-prevention-100581282","NCT06848283","Randomized Controlled Trial on Carotid Atherosclerosis Screening in Asymptomatic Smokers and Hypertensive Adults: Prevalence and Impact on Cardiovascular Prevention","Carotid Atherosclerosis Screening: Epidemiological Profile and Preventive Intervention","CAROTID-CARE","Inclusion Criteria:\n\n* Adults aged ≥40 years and \\\u003C70 years, hypertensive and smokers\n* Registered in ACeS Maia\u002FValongo\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* Inability to provide consent.\n* Patients with a previous stroke, symptomatic coronary artery disease, or symptomatic peripheral artery disease will be excluded.","40 Years",{"count":471,"type":23},4780,[26],"Title of the study: Carotid Atherosclerosis Screening: Epidemiological Profile and Preventive Intervention.\n\nObjective: The main objective of this study is to characterize and identify the prevalence of carotid atherosclerosis in adults who are still asymptomatic for vascular disease and to evaluate the impact of detecting carotid atherosclerosis on preventive strategies. The study covers a population of approximately 4,780 patients.\n\nEstimated Duration of the Project: The estimated duration of the project is 36 months, starting in February 2025, with the possibility of an extension if necessary.\n\nEntities that approved the study: This study has been reviewed and approved by the Executive Director and President of the Clinical and Health Council of ACeS Grande Porto III - Maia\u002FValongo, as well as the Health Ethics Committee of the Northern Regional Health Administration (ARS Norte). The Addendum has also been approved by the Ethics Committee of the São João Local Health Unit (ULS São João).\n\nExplanation of the Study:\n\nThis study will take place at ULS São João, including the São João University Hospital Center and the Primary Care Grouping (ACeS) Grande Porto III - Maia\u002FValongo.\n\nThe study includes two groups. Patients in the intervention group will undergo a neck ultrasound (a non-invasive imaging exam) for the early detection of atherosclerotic plaques. Demographic data (sex, age, educational level, employment status), vascular risk factors (smoking, alcohol consumption, blood pressure, and lipid profile), and anthropometric data (waist circumference and BMI) will be documented and analyzed by the research team. Medication, previous treatments, and other preventive initiatives will also be recorded. Glycemic and lipid profiles of participants will be collected.\n\nBased on the results, the individual cardiovascular risk will be calculated using the SCORE2 global cardiovascular risk assessment chart from the European Society of Cardiology, both before and after incorporating ultrasound findings. Subsequently, personalized recommendations for preventive and therapeutic strategies will be developed for each patient and shared with family physicians.\n\nTo identify potential vascular risk biomarkers, venous blood samples will be collected in the intervention group. Patients identified with high-risk atherosclerotic plaques will be referred for further evaluation at the Neurology\u002FCerebrovascular Disease outpatient clinic of the São João University Hospital Center, ULS São João.\n\nPatients in the other group (control group) will follow the same protocol, except for the neck ultrasound. To identify potential vascular risk biomarkers, venous blood collection will be performed in the intervention group during the carotid ultrasound (Doppler ultrasound). Both groups will be reassessed at a later stage. If a participant meets the exclusion criteria for the study, this will be duly explained to them.",[475,476],"Carotid Artery Atheroma","Cardiovascular Risk Stratification",{"date":456,"type":43},{"date":479,"type":23},"2025-02",{"date":481,"type":23},"2028-02",{"name":49,"class":50},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":18,"sex":19,"minAge":490,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":367,"phases":4,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":51},"100578817","association-between-sleep-and-psychomotor-development-in-early-childhood-100578817","NCT06816225","Association Between Sleep and Psychomotor Development in Early Childhood","SleePsy","Inclusion Criteria:\n\n* Children aged 2 and 6 months year until the first assessment;\n* Gestational age at birth 37 weeks or more;\n* Delivery without serious complications for the child;\n* Absence of developmental pathologies or pathologies that interfere with psychic and motor development;\n\nExclusion Criteria:\n\n* Non-preterm birth but with severe growth restriction;\n* Diagnosis of psychomotor development pathology;\n* Diagnosis of pathology that interferes with psychomotor development;\n* Taking daily medication, except vitamin supplements.","2 Years","4 Years",{"count":493,"type":23},119,"Sleep is a neurophysiological active process essential for healthy physical and cognitive development. In Portugal, there is no recent and objective data on how children sleep.\n\nGiven the importance of sleep in child health and development as well as the health gains achieved by establishing healthy sleep patterns since childhood, it seems extremely relevant to assess the various sleep parameters of Portuguese children and correlate them with their psychomotor and anthropometric development indicators. The results of this research work may support the implementation of sleep health education measures among parents, educators and policy makers, thus contributing to support the implementation of practices that promote sleep quality, napping until later in life as well as to promote the health of future adults.",[496],"Sleep",[498,499,500,501],"childhood,","psychomotor development","melatonin","actigraphy","2025-02-03",{"date":435,"type":43},{"date":505,"type":43},"2023-06-01",{"date":507,"type":23},"2025-12-01",{"name":49,"class":50},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":24,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":51},"100575165","early-warning-system-for-allergic-rhinitis-in-the-mask-air-app-100575165","NCT06768736","Early Warning System for Allergic Rhinitis in the MASK-air® App","Randomised Controlled Trial on an Early Warning System for Allergic Rhinitis in the MASK-air® App","Inclusion Criteria:\n\n\\- Adult patients (≥18 years old) of both sexes with clinical diagnosis of allergic rhinitis according to ARIA associated with pollen allergy.\n\nExclusion Criteria:\n\n* Illiterate patients\n* Patients without smartphone\n* Patients who are not able to complete a daily monitoring questionnaire on allergic rhinitis.",{"count":345,"type":23},[26],"The primary objective consists in the comparison of the combined symptom medication score values between (i) patients randomised to the early warning system personalised forecasting messages, and (ii) patients randomised to generic messages already delivered by MASK-air®.\n\nThe combined symptom medication score has recently been developed in a data-driven way and validated (https:\u002F\u002Feaaci.org\u002Fimages\u002FCSMS.pdf); it assesses allergic rhinitis control taking into account both reported symptoms and medication use.\n\nAs secondary objectives, visual analogue scales on allergic rhinitis symptoms (VAS global, nasal, eye, asthma), and medication use will also be separately compared.",[520],"Allergic Rhinitis",{"date":522,"type":43},"2025-02-06",{"date":524,"type":23},"2025-01-30",{"date":526,"type":23},"2026-05-15",{"name":49,"class":50},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":537,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":51},"100577771","prehabilitation-for-lung-cancer-patients-undergoing-lung-resection-100577771","NCT06802627","Prehabilitation for Lung Cancer Patients Undergoing Lung Resection","Influence of Prehabilitation on Postoperative Pulmonary Complications in Patient Undergoing Lung Resection Surgery","Fit4LungNeo","Inclusion Criteria:\n\n* Adult patients accepted for lung resection surgery, due to lung cancer, at the Cardiothoracic Department of Unidade Local de Saúde São João\n* Not included in any type of prehabilitation program\n\nExclusion Criteria:\n\n* Diagnosis of cardiac, or hematological or neurologic diseases\n* Pulmonary hypertension\n* Renal failure\n* Patients that underwent previous thoracic surgery\n* Patients submitted to pneumectomy\n* Patients with cognitive and mental disorders\n* Patients with impairments in autonomous deambulation\n* Patients already included in any prehabilitation program",{"count":421,"type":23},[26],"Lung surgical resection is the gold standard treatment for earlier stages of lung cancer patients. Nevertheless, postoperative pulmonary complications (PPC) are frequent, related to morbidity and mortality, increasing length of hospital stay (LOS), hospital costs, delaying adjuvant treatments, and patients suffering. The PPC often occurs on postoperative days, even after hospital discharge. Prehabilitation might reduce PPC, although few studies have compared the effectiveness of different training protocols, and no information is available regarding the possible benefits of expiratory muscle training. Moreover, there are no comparisons of the cost-benefits of other protocols in patients submitted to lung resection surgery.\n\nThis project investigates the effectiveness of and compares four different prehabilitation protocols in reducing PPC and LOS in patients selected for lung cancer resections.\n\nParticipants will be individuals referred to surgical resection due to lung cancer. Patients who meet the inclusion criteria will be invited to participate in the study. After clinical data collection, patients will be randomly allocated (simple method) into four groups \\[Control - CG, receiving an education session; Inspiratory muscle training group (IMT-G) receiving education session plus inspiratory muscle training (IMT); expiratory muscle training group (EMT-G) receiving education session plus expiratory muscle training (EMT); global exercise training group (GET-G) receiving education session plus a general exercise training (GET)\\], and evaluated for functional capacity (pulmonary function, respiratory muscle function, physical fitness, daily physical activity, dyspnoea, fatigue, quality of life, anxiety, depression, and a 24-hour food diary. Afterward, all patients will receive an education class and written information regarding healthy habits to follow before, during, and after hospital discharge. Patients allocated to exercise groups will start the prehabilitation intervention for two weeks. After the intervention, patient assessments will be repeated. After that, patients will be submitted to surgery, and anesthetic and surgical procedure data will be collected. During hospital recovery, all patients will receive physiotherapy and any etiological complications and the LOS will be recorded according to medical criteria. After hospital discharge, PPC will be monitored and recorded for 30 days; by then, patients will be submitted to the final assessment.",[540,541],"Lung Cancer","Lung Resection",[543,544,545,546,547,548],"Prehabilitation","Lung resection","Exercise training","Postoperative pulmonary complications","Respiratory muscle training","Education","2025-01-24",{"date":551,"type":43},"2025-01-31",{"date":553,"type":23},"2025-03-01",{"date":555,"type":23},"2027-11-30",{"name":49,"class":50},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":18,"sex":315,"minAge":20,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":24,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":51},"100568609","emote-a-smartphone-application-for-binge-eating-based-on-dbt-skills-100568609","NCT06683456","EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills","EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills: a Randomized Controlled Trial","Inclusion Criteria:\n\n* female;\n* aged 18 years or older;\n* self-report at least one binge eating episode over the past four weeks;\n* owned a smartphone;\n* fluent in Portuguese.\n\nExclusion Criteria:\n\n* attending psychotherapy (face-to-face or digital) or another clinical trial;\n* body mass index below 18.5;\n* self-report an average of eight or more episodes of binge eating or inappropriate compensatory behaviours per week;\n* being pregnant;\n* self-report bipolar disorder, psychotic disorder, substance abuse, suicidal ideation or borderline personality disorder.","60 Years",{"count":566,"type":23},68,[26],"Binge eating, whether formally diagnosed or occurring at subthreshold levels, is associated with adverse health consequences and decreased quality of life.\n\nAccess to accessible, cost-effective interventions that effectively address binge eating episodes is critical for individuals with this condition, and smartphone applications have demonstrated promise in treating binge eating and related disorders.\n\nThis study aims to evaluate the efficacy of eMOTE, a novel smartphone application for binge eating based on Dialectical Behavior Therapy (DBT) skills. For this purpose, a randomized controlled trial will be conducted in which women who self-report binge eating episodes will be randomly assigned to the app intervention group or a waiting list group.",[570],"Binge Eating",[572,570,573,574],"DBT","Feeding and Eating Disorders","Application","2024-11-08",{"date":577,"type":43},"2024-11-12",{"date":579,"type":43},"2024-04-01",{"date":581,"type":23},"2025-03-15",{"name":49,"class":50},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":367,"phases":4,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":601,"locationsCount":4},"100565943","predictors-of-therapeutic-success-and-adverse-events-in-endoscopic-ampullectomy-100565943","NCT06648746","Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy","Inclusion Criteria:\n\n* Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:\n\n  * lesions up to 30 mm (including with laterally spreading component)\n  * with low-grade or high-grade dysplasia on preprocedural histology\n  * with no intraductal extension\n  * with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)\n* A minimum follow-up period of one year afer endoscopic ampullary resection.\n\nExclusion Criteria:\n\n* Patients with lesions with the following features were excluded:\n\n  * intraductal extension\n  * evidence of invasive malignancy\n  * other non-adenomatous lesions\n* Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment\n* Patients with a follow-up of less than a year after endoscopic ampullary resection\n* Patients with pancreas divisum.",{"count":590,"type":23},100,"Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (\\\u003C1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.\n\nNonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and\u002For delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.",[593,594],"Ampulla of Vater Adenoma","Ampulla of Vater Disease (Benign\u002FMalignancy)","2024-10-16",{"date":597,"type":43},"2024-10-18",{"date":599,"type":23},"2024-12",{"date":599,"type":23},{"name":49,"class":50},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":19,"minAge":391,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":24,"phases":611,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":251},"100556051","phase-4-optimal-articular-solutions-with-intraosseous-and-synovial-platelet-rich-plasma-100556051","NCT06520059","Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma","Comparison of Efficacy of Intraosseous vs Intra-articular Injections of PRP for Advanced Knee OA","OASIS-PRP","Inclusion Criteria:\n\n* Adult individuals with unilateral or bilateral symptomatic knee OA diagnosis according to the American College of Rheumatology\n* with symptoms for more than 3 months\n* confirmed with radiologic diagnosis (Kellgren-Lawrence grades III or IV).\n* Patients must be able to walk with a painful knee.\n\nExclusion Criteria:\n\n* previous history of knee surgery\n* systemic autoimmune or rheumatic disease\n* platelet diseases\n* use of NSAIDs 3 days prior the injections\n* previous history (last 3 months) of systematic use of corticosteroids\n* or other intra-articular injections in the knee in the past 6 months",{"count":116,"type":23},[612],"PHASE4","This is a prospective cohort clinical study. Due to logistic constraints at the sites of implementation, a randomized allocation will not be feasible (private clinic). Patients will be selected with the aim of matching for important confounders (sex and age) the grade of knee OA will be restricted to advance stages.",[615],"Knee Osteoarthritis",[617,618,619],"Injections, Intra-Articula;","Regenerative Medicine;","Cartilage Repair","2024-08-02",{"date":622,"type":43},"2024-08-06",{"date":624,"type":23},"2025-01-01",{"date":626,"type":23},"2027-10-31",{"name":49,"class":50},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":19,"minAge":469,"maxAge":635,"enrollmentInfo":636,"targetDuration":4,"studyType":24,"phases":638,"briefSummary":639,"conditions":640,"keywords":642,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":51},"100555723","evaluation-of-two-isometric-exercises-in-the-reduction-of-the-blood-pressure-in-people-with-resistant-hypertension-100555723","NCT06515795","Evaluation of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension","Evaluation of the Safety and Efficacy of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension","Inclusion Criteria:\n\n* Adults aged 40 to 75 years old, previously diagnosed with resistant hypertension, and on stable medication for at least 6 months.\n\nExclusion Criteria:\n\n* People with secondary hypertension, heart failure, peripheral artery disease, atrial fibrillation, chronic obstructive pulmonary disease or renal failure; people with a cerebro-cardiovascular event in the previous 3 months; people with changes in pharmacological therapy in the previous 6 months; trained people (with regular participation (≥ 2x\u002Fweek) in exercise training programs in the previous 3 months); people who have any contraindication to exercise; people with neurological and\u002F or orthopaedic conditions that will interfere with their participation in exercise, such as Parkinson's disease or knee osteoarthritis. Participants with low score (\\\u003C6) on the MMAS-8 will also be excluded.","75 Years",{"count":637,"type":23},15,[26],"Hypertension remains the main preventable cause of cardiovascular disease (CVD) and all-cause mortality, both in Europe and globally. Resistant hypertension, a severe phenotype of hypertension, is defined as a blood pressure (BP) that remains above the management goal despite using three different antihypertensive agents of different classes at the maximum or maximum tolerated dose, or controlled BP on four or more antihypertensive medications. Hypertension remains a poorly controlled risk factor on a global scale and the prevalence of resistant hypertension is also growing - it is now estimated to be around 10-20%.\n\nAt the moment, there is robust evidence establishing the antihypertensive effects of exercise. The acute reduction of BP after a single bout of exercise is known as post-exercise hypotension.\n\nIn recent years, the number of investigations into the benefits of isometric exercise in the treatment of hypertension has increased, due to its ease of access and potential for use. In a recently published meta-analysis, the authors pointed to isometric exercise as the most effective type of exercise in reducing systolic and diastolic BP.\n\nGiven the scarceness of data regarding the safety and efficacy of isometric exercise in individuals with resistant hypertension and since the acute response to exercise may help to identify people who respond to exercise as antihypertensive therapy, the objective of this study is to analyse the acute effect on BP levels of two different isometric exercises - isometric handgrip (IHG) and isometric wall squat (IWS), regarding safety and efficacy, in people with resistant hypertension.\n\nThe aim is to analyse if isometric exercises are safe in this population, through the assessment of BP during the execution of the exercises. Besides that, the comparison of IHG and IWS with the control session and between one and another, will help to understand which form of isometric exercise is most effective and has the longest lasting impact on reducing BP.\n\nEach participant must complete an acclimatization session, in which the procedures will be explained, data will be collected and the intensity of IHG and IWS will be assessed. Subsequently, each participant must complete three randomly assigned experimental sessions: a non-exercise control session and two exercise sessions, in which they will follow the protocols currently used in the literature (IHG at 30% of Maximum Voluntary Contraction and IWS at 95% of peak Heart Rate).",[641],"Resistant Hypertension",[643,644,645,646,647],"resistant hypertension","isometric exercise","handgrip","wall squat","blood pressure","2024-07-17",{"date":650,"type":43},"2024-07-23",{"date":652,"type":43},"2024-07-11",{"date":654,"type":23},"2024-09",{"name":49,"class":50},{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":367,"phases":4,"briefSummary":664,"conditions":665,"keywords":672,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":692},"100554367","active-pharmacovigilance-study-of-the-medicine-rinvoq-upadacitinib-100554367","NCT06498167","Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)","LOOK-UP","Inclusion Criteria:\n\n* Prescription of Rinvoq™ from January 1, 2024;\n* 18 years of age or older at the time of recruitment; and\n* Expressed consent to participate in the study.\n\nExclusion Criteria:\n\n* They have any degree of cognitive impairment that prevents them from responding to a questionnaire administered by telephone;\n* They are participating in a phase I, II, or III clinical trial;\n* They have a life expectancy of less than 1 month; or\n* They do not have a valid telephone contact.",{"count":262,"type":23},"The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. The Marketing Authorisation Holder is AbbVie Deutschland GmbH \\& Co. KG.",[666,667,668,669,670,671],"Inflammatory Disease","Drug Side Effect","Drug Use","Adverse Drug Event","Adverse Drug Reaction","Safety Issues",[673,674,675,676,677,678,679,680,681,682,683],"Upadacitinib","Rinvoq","Rheumatoid arthritis","Psoriatic arthritis","Axial spondyloarthritis","Atopic dermatitis","Ulcerative colitis","Crohn's disease","Pharmacovigilance risk","Drug safety monitoring","Patient Safety","2024-07-12",{"date":686,"type":43},"2024-07-15",{"date":688,"type":43},"2024-07-01",{"date":690,"type":23},"2024-12-31",{"name":49,"class":50},3,""]