[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Region Örebro County\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":666},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,44,71,103,134,160,202,231,256,285,323,355,380,402,432,458,485,513,536,559,586,612,641],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100641492","functional-vision-and-quality-of-life-in-a-modern-society---with-emphasis-on-myopia-and-cerebral-visual-impairment-among-youth-100641492",false,"NCT07653074","Functional Vision and Quality of Life in a Modern Society - With Emphasis on Myopia and Cerebral Visual Impairment Among Youth","Inclusion Criteria:\n\n* Healthy children\n\nExclusion Criteria:\n\n* Children with ophthalmological diagnosis followed frequently by the ophthalmological clinic",true,"ALL","17 Years",{"count":19,"type":20},300,"ESTIMATED","1 Day","OBSERVATIONAL","Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions. This puts greater demands on our vision and our ability to interpret what we see. At the same time, the number of children with nearsightedness (myopia) has increased rapidly. In some parts of Asia, as many as 60-70% of students in seventh grade are nearsighted (1), and a similar trend may develop in Europe.\n\nNearsightedness is becoming a growing challenge in pediatric eye care. High myopia can lead to complications that require early detection and prevention. There are now several ways to slow down its progression, such as special contact lenses, glasses, and eye drops (2). However, the scientific evidence for these treatments varies, and there are currently no national or Nordic guidelines on how to use them. In addition, myopia may have a major impact on children's quality of life.\n\nCurrently, there is no validated Swedish questionnaire that measures vision related quality of life across all age groups in children and adolescents. To address this, researchers in the United States developed the Pediatric Eye Questionnaire (PedEyeQ) in 2019 (3). It is already available in English and Spanish and takes into account both the child's and the parent's perspectives on vision and daily life.\n\nThe aim of this study is to translate, culturally adapt and test the PedEyeQ in Swedish children and adolescents, and to investigate how common refractive errors, especially nearsightedness - are today compared to 20-30 years ago.\n\nThe study will include 300 healthy children and adolescents aged 0-17 years, divided into three age groups: 0-4 years, 5-11 years, and 12-17 years. Participants will be recruited through child health centers, preschools, and schools in the Örebro region.\n\nAll participants will visit the eye clinic for a detailed eye examination, including:\n\n* Testing distance and near visual acuity\n* Measuring eye refraction (with and without eye drops that temporarily relax the eye's focusing muscles)\n* Imaging the retina using Optical Coherence Tomography (OCT)\n* Measuring eye length and corneal shape\n* Checking eye pressure and contrast sensitivity\n\nChildren and parents will also answer questions about how the child's vision affects everyday life and wellbeing. For the youngest children (0-4 years), only parents will answer the questions.\n\nThe PedEyeQ will be translated into Swedish following the International Society for Pharmacoeconomics and Outcome Research (ISPOR) (4) guidelines to make sure it is culturally relevant and easy to understand. The Swedish version will then be tested to ensure it is accurate and reliable.\n\nAll information collected in the study will be stored securely and anonymously. The results will also be compared with data from a similar cohort conducted in the 1990s to see if vision problems have become more common over time (5).\n\nThis project will provide new knowledge about children's vision and quality of life in Sweden. A validated Swedish version of the PedEyeQ can be used both in healthcare and research to better understand how vision affects children's daily lives. The study will also offer updated information on the frequency of refractive errors among Swedish children and adolescents - knowledge that is essential for developing preventive strategies and improving eye care for the future.",[25,26],"Myopia","Quality of Life",[28,29,30],"Quality of life","myopia","Sweden","RECRUITING","2026-06-11",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2024-10-27",{"date":39,"type":20},"2029-05-30",{"name":41,"class":42},"Region Örebro County","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100570787","treatment-of-adolescent-anorexia-nervosa-100570787","NCT06711783","Treatment of Adolescent Anorexia Nervosa","VISAN - vårdkedja i Samverkan för Unga Patienter Med Anorexia Nervosa (Collaborative Chain of Care in Adolescnt Anorexia Nervosa Treatment)","VISAN","Inclusion Criteria:\n\n* Having been diagnosed with f500 or f501 and being planned for family based therapy at the unit.\n\nExclusion Criteria:\n\n* being subjected to care by the social welfare system","11 Years",{"count":54,"type":20},60,"INTERVENTIONAL",[57],"NA","VISAN is a naturalistic study of family based treatment of Anorexia nervosa in adolescnet girls.",[60],"Eating Disorders",[62],"anorexia nervosa","2026-04-30",{"date":65,"type":35},"2026-05-01",{"date":67,"type":35},"2024-08-01",{"date":69,"type":20},"2029-12-31",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":55,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100541934","phase-4-effect-of-influenza-vaccination-after-myocardial-infarction-on-cardiac-inflammatory-response-100541934","NCT06336317","Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE","Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)","ELIMINATE","Inclusion Criteria:\n\n* Patients with a diagnosis of non-ST-segment elevation myocardial infarction\n* A finalized coronary PCI\n* Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)\n* Written informed consent\n* A CCTA can be scheduled within 7 days after PCI\n\nExclusion Criteria:\n\n* Has received influenza vaccination within 6 months\n* Other vaccination planned within 8 weeks (including covid-19 booster doses)\n* Severe allergy to eggs or previous allergic reaction to influenza vaccine\n* Cardiac surgery or staged PCI planned within 8 weeks\n* Coronary stent involving the proximal RCA\n* Suspicion of febrile illness or acute, ongoing infection\n* Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol\n* Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response\n* Inability to provide informed consent\n* Previous randomization in the ELIMINATE trial\n* Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.\n* Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment \\[eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2\\])\n* Atrial fibrillation\n* Uncontrolled chronic inflammatory disease\n* Unable to comply with protocol requirements","18 Years",{"count":81,"type":20},90,[83],"PHASE4","The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:\n\nDoes influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.",[86,87,88],"Acute Myocardial Infarction","Cardiovascular Diseases","Inflammatory Response",[90,91,92,93],"Coronary computed tomography angiography","Percutaneous coronary intervention","Influenza vaccine","Non ST-segment elevation myocardial infarction","2026-04-01",{"date":96,"type":35},"2026-04-07",{"date":98,"type":35},"2024-04-24",{"date":100,"type":20},"2027-12",{"name":41,"class":42},3,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":15,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100624216","hemodynamic-venous-congestion-ultrasound-vexus-by-icu-nurses-in-sepsis-patients-100624216","NCT07406750","Hemodynamic Venous Congestion Ultrasound (VExUS) by ICU Nurses in Sepsis Patients.","Hemodynamic Diagnostic Ultrasound of Venous Congestion (VExUS) Performed by Intensive Care Nurses on Patients With Sepsis.","VEXIVAN","Inclusion Criteria:\n\nIntensive Care Nurses a) Intensive care nurse, specialist degree in intensive care. b) ≥1,5 years of experience in intensive care. c) ≥75% clinical employment rate at the ICU. d) Continued employment until 2026 at the ICU at Örebro University Hospital. e) Written informed consent Intensive Care Patients\n\n1. Patients with suspected or verified sepsis according to the Sepsis 3 criteria (suspected or confirmed infection), ≥qSOFA (systolic blood pressure \\\u003C 90 mmHg, GCS ≤ 13, respiratory rate ≥ 22 per minute) or rise in SOFA score ≥ 2 points and admitted to the ICU.\n2. ≥18 years of age.\n\nExclusion Criteria:\n\nIntensive Care Nurses\n\na) Personnel with primarily an administration position or less clinical duty at the ICU.\n\nIntensive Care Patients\n\n1. Patients with preexisting liver cirrhosis.\n2. Pregnancy.",{"count":112,"type":20},46,"Sepsis is a serious condition where the body's immune response to infection overreacts, leading to organ damage and death. Venous congestion, a buildup of blood in the veins, can occur in sepsis and contribute to organ injury. VExUS (Venous Excess Ultrasound Score) is an ultrasound method that can detect congestion early. This study examines whether ICU nurses, after training, can perform VExUS reliably, explores their experiences, and investigates links between VExUS findings and clinical outcomes.",[115,116,117,118],"Sepsis","Sepsis and Septic Shock","Sepsis at Intensive Care Unit","Intensive Care Nurses",[120,121,122,123,124,125],"sepsis","intensive care","ultrasound","venous congestion","VExUS","intensive care nurse","NOT_YET_RECRUITING","2026-02-13",{"date":129,"type":35},"2026-02-18",{"date":94,"type":20},{"date":132,"type":20},"2027-05-31",{"name":41,"class":42},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":55,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100622049","intervention-to-master-complex-fall-risk-situations-in-persons-with-multiple-sclerosis-star-100622049","NCT07378566","Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis (STAR)","Digitally Supported Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis - a Multicenter Study (STAR)","STAR","Inclusion Criteria:\n\n* Diagnosed with MS\n* Affected ability to walk du to MS according to the participant\n* At least one self-reported fall the last 3 months due to MS according to the participant\n\nExclusion Criteria:\n\n* Unable to walk 100m even with walking device and\u002For pauses.\n* Apparently affected walking ability due to other conditions such as for example orthopedic or other neurological diseases.\n* Difficulty to answer questionnaires written in Swedish",{"count":143,"type":20},80,[57],"People with multiple sclerosis (MS) have a higher fall risk compared to older people and to the general population. A meta-analysis reported that 56% of those with mild to moderate MS, fell at least once during a 3-month period. The risk of falling seems to peak when the walking distance starts to be affected and when walking aids are introduced and the walking distance is as short as 100 m. Previous studies have identified a number of fall risk factors, both relating to MS- symptoms and contextual factors. In a study published in 2025, we reported the complexity of fallsituations and the interaction between triggering factors, contextual factors and activities and circumstances that occurred before the fall incidents . The symptoms when having MS varies between individuals as well as over time. I the planned randomised, controlled multicenter study we move forward, producing individual fallrisk analyses based upon the findings from the study published in 2025, and offer individual strategies. This has not been studied before. All participants will receive general information on how fall risk can be prevented. Those randomised to control group will be offered the intervention after ending of the study. The study will be conducted in two phases starting with an internal pilot study followed by a full scale randomized controlled trial (RCT).",[147,148],"Multiple Sclerosis","Fall",[150,151],"falls","prevention","2026-01-22",{"date":154,"type":35},"2026-01-30",{"date":156,"type":20},"2026-01-01",{"date":158,"type":20},"2028-12-31",{"name":41,"class":42},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":55,"phases":170,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":201,"locationsCount":4},"100618631","phase-4-general-anaesthesia-vs-spinal-anaesthesia-patient-outcomes-and-success-in-outpatient-primary-total-knee-and-hip-arthroplasty-100618631","NCT07334132","General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty","GASPS","Inclusion Criteria:\n\n1. The participant has given their written consent to participate in the trial.\n2. Planned for primary TKA or THA.\n3. Adults aged 18 to 80 years at time of written consent.\n4. ASA (American Society of Anaesthesiologists) classification 1 or 2, or 3 without significant functional impairment.\n5. Scheduled start of surgery before 13:00.\n6. Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.\n\nExclusion Criteria:\n\n1. Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).\n2. Body mass index (BMI) \\> 35 kg\u002Fm.\n3. Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.\n4. Haemoglobin \\\u003C 120 g\u002FL (sample no older than 3 months).\n5. Known bleeding disorders, including coagulopathies.\n6. Known allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol).\n7. Neurological conditions with persistent motor or sensory deficits.\n8. Localised infections at the spinal injection site.\n9. Determined by the surgical or anaesthesia team to be unsuitable for trial participation and\u002For outpatient surgery.\n10. Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile)\n\n    1. Who are not willing to use a highly effective method of contraception judged by the investigator, from the time of signing the informed consent, OR\n    2. Who has a positive pregnancy test at enrolment","80 Years",{"count":169,"type":20},600,[83],"Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. This can be beneficial for both patients and healthcare systems, but it requires safe and efficient anaesthetic care.\n\nTwo different types of anaesthesia are commonly used for these operations: general anaesthesia (where the patient is asleep) and spinal anaesthesia (where the lower part of the body is numbed). Both methods are well established and widely used. Previous studies suggest that the choice of anaesthesia may affect how quickly patients recover, how comfortable they feel after surgery, and whether they can be safely discharged on the day of surgery. However, most existing studies are based on retrospective data, and there is limited randomized evidence comparing these anaesthetic techniques in the outpatient setting.\n\nThe GASPS trial is a multicentre, randomized, phase IV clinical study that compares general anaesthesia and spinal anaesthesia in adults undergoing outpatient primary total knee or hip arthroplasty. A total of 600 participants will be included and randomly assigned to receive one of the two anaesthetic methods on the day of surgery. All participants will receive standard surgical and perioperative care, and both anaesthetic techniques are part of routine clinical practice.\n\nThe main aim of the study is to investigate whether the type of anaesthesia influences the chance of successful same-day discharge, defined as going home on the day of surgery without needing to be readmitted within 48 hours. The study will also examine recovery time, pain, nausea and vomiting, use of pain medication, complications, patient-reported recovery and function, and healthcare costs. In addition, patient experiences of anaesthesia and postoperative recovery will be explored through interviews in a smaller group of participants.\n\nParticipants will be followed using questionnaires and medical records from the day of surgery up to 12 months after the operation. The results of this study are expected to provide clear and reliable information to help guide anaesthetic care for patients undergoing outpatient hip and knee replacement surgery.",[173,174,175],"Osteo Arthritis Knee and Hip","Osteo Arthritis","Inflammatory Joint Disease (IJD)",[177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195],"Total Knee Arthroplasty","Total Hip Arthroplasty","Outpatient Surgery","Same-Day Discharge","Ambulatory Arthroplasty","General Anaesthesia","Spinal Anaesthesia","Neuraxial Anaesthesia","Total Intravenous Anaesthesia","Postoperative Recovery","Quality of Recovery","QoR-15","Postoperative Pain","Postoperative Nausea and Vomiting","PONV","Patient-Reported Outcomes","Health Economic Evaluation","Cost-Effectiveness","Randomized Clinical Trial","2026-01-02",{"date":198,"type":35},"2026-01-12",{"date":94,"type":20},{"date":69,"type":20},{"name":41,"class":42},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":55,"phases":211,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100594977","phase-4-right-sided-1-hz-repetitive-transcranial-magnetic-stimulation-rtms-versus-left-sided-intermittent-theta-burst-stimulation-itbs-in-patients-with-depression-100594977","NCT07026461","Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression","Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial","Inclusion Criteria:\n\n* At least 18 years of age at the time of inclusion.\n* A clinical diagnosis of unipolar or bipolar depression according to ICD-10.\n* Acceptance of rTMS.\n* A Swedish personal identity number.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n• If the investigator judges one of the two treatment protocols inappropriate for the patient.",{"count":210,"type":20},350,[83],"Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.\n\nDesign: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.\n\nPrimary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.\n\nSecondary objectives: Include testing for differences in:\n\n* Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI).\n* Response to treatment (a decrease of 50% on MADRS-S)\n* Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS).\n* Drop-out from treatment.\n* Stimulation site pain measured with the Numerical Rating Scales (NRS).\n* Adverse events.\n* Admission and suicides within 6 months.\n* New treatment course of rTMS or ECT within 6 months\n* Remission (score \\\u003C 11 on the MADRS-S)\n* Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS).\n\nStudy population: Patients with unipolar or bipolar depression. Sample size: 350 patients.\n\nInclusion criteria:\n\n* At least 18 years of age at the time of inclusion.\n* A clinical diagnosis of unipolar or bipolar depression according to ICD-10.\n* Acceptance of rTMS.\n* A Swedish personal identity number.\n* Capable of giving informed consent.\n\nExclusion criteria:\n\n• If the investigator judges one of the two treatment protocols inappropriate for the patient.\n\nInclusion time: 2025-07-01 to 2029-01-01",[214,215],"Depression - Major Depressive Disorder","Depression Bipolar",[217,218,219,220,221],"rtms","itbs","repetitive transcranial magnetic stimulation","randomized controlled trial","intermittent theta-burst stimulation","2025-12-08",{"date":224,"type":35},"2025-12-16",{"date":226,"type":20},"2025-12-15",{"date":228,"type":20},"2031-12-31",{"name":41,"class":42},2,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":55,"phases":239,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":43},"100608791","physical-exercise-as-treatment-post-stroke-fatigue---a-feasibilty-study-100608791","NCT07206147","Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study.","Inclusion Criteria:\n\n\\- Stroke ≥6 months, able to move independently ≥100 meters with or without a walking aid, speak Swedish, Fatigue assessment scale (FAS) ≥24 points\n\nExclusion Criteria:\n\n* Other neurological disease. Severe impairment of vision, hearing and\u002For cognition that prevents participation in the intervention. Already performs structured strength training (e.g. gym, group training) regularly (at least 1 time\u002Fweek).",{"count":238,"type":20},16,[57],"The goal of this clinical trial is to evaluate the feasibility the treatment FaStEx (FatigueStrokeExercise) which consists of strength exercise in people with brain fatigue after stroke, referred to as post-stroke fatigue. The main questions it aims to answer are:\n\n* What is the feasibility of a study with the treatment FaStEx, structured physical training, for people with post-stroke fatigue?\n* What factors are important for people with post-stroke fatigue to be able to complete the FaStEx treatment?\n* How do people with post-stroke fatigue experience participation in the study with the FaStEx treatment?\n\nResearchers will compare FaStEx to physical activity at home to see if FaStEx can reduce post-stroke fatigue.\n\nParticipants will\n\n* Carry out strength training twice a week at a health care center.\n* Carry out physical activity for at least 150 minutes per week on their own. Participants in the control group will carry out this physical activity as well.\n* The treatment lasts for eight weeks.",[242,243],"Stroke","Fatigue Symptom",[245,242,246,247,248],"Post-stroke fatigue","Physical exercise","Physical activity","Physiotherapy","2025-09-25",{"date":251,"type":35},"2025-10-03",{"date":156,"type":20},{"date":254,"type":20},"2026-06-01",{"name":41,"class":42},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":264,"minAge":4,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":55,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":43},"100605101","a-digitally-distributed-yoga-intervention-in-prostate-cancer-rehabilitation--protocol-for-a-randomized-controlled-trial-100605101","NCT07158138","A Digitally Distributed Yoga Intervention in Prostate Cancer Rehabilitation : Protocol for a Randomized Controlled Trial","A Digitally Distributed Yoga Intervention in Prostate Cancer Rehabilitation (DigiYoga-P): Protocol for a Randomized Controlled Trial","Digiyoga-P","Inclusion Criteria: are men diagnosed with prostate cancer without signs of metastatic disease, treated with curative intent. They should be Swedish-speaking and literate. Participants can be included within two months of diagnosis\n\n\\-\n\nExclusion Criteria:\n\n* are individuals under active surveillance or with advanced disease.","MALE",{"count":266,"type":20},220,[57],"Prostate cancer and its treatment can affect psychological, physical, and social quality of life. The most common side effects of the disease and treatment are bowel and urinary problems, sexual issues, and reduced quality of life. These issues can be alleviated with proper treatment and rehabilitation. Stress has been shown to be a significant factor in reduced quality of life.\n\nThe overall aim of the research project is to evaluate and compare the effect of an internet-based yoga intervention for individuals diagnosed with prostate cancer with a control group receiving standard care regarding stress, urinary incontinence, blood pressure, and quality of life. Additional objectives include describing cost-effectiveness and the experience of participating in an internet-based yoga intervention at home.\n\nScientific Questions Does internet-based yoga have any effect on stress, urinary incontinence, blood pressure, and quality of life compared to standard care? Is internet-based yoga a cost-effective intervention from the perspective of healthcare and society compared to standard care? How feasible is internet-based yoga, and how do participants perceive it? Does blood pressure change due to digital yoga, and does the effect persist after one year? Do participants in the intervention group continue practicing yoga after the intervention ends?",[270],"Prostate Cancer Patients",[272,273,274,275,276],"RCT","rehabilitation","yoga","Digital","prostate cancer","2025-08-28",{"date":279,"type":35},"2025-09-05",{"date":281,"type":20},"2026-01-10",{"date":283,"type":20},"2030-01-10",{"name":41,"class":42},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":15,"sex":16,"minAge":293,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":55,"phases":296,"briefSummary":297,"conditions":298,"keywords":303,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100601529","evaluation-of-the-school-based-sim-program-in-upper-secondary-school-students-100601529","NCT07111676","Evaluation of the School-based SIM Program in Upper Secondary School Students","Evaluating the Efficacy and Cost-effectiveness of the School-based Solution-focused Intervention for Mental Health (SIM) in First Year of Upper Secondary School Students","SIMRCT1","Inclusion Criteria:\n\n* first and second-year upper secondary school students\n* students enrolled in regular school programs\n\nExclusion Criteria:\n\n* students with insufficient knowledge of the Swedish language\n* students who are absent during the information meeting or could not be reached for a separate meeting to receive the accurate information\n* students who are absent at the start session or cannot be reached to complete the baseline prior to the first themed SIM session\n* students who for various reasons (e.g. functional impairments) are unable to participate in an ordinary teaching situation.","15 Years",{"count":295,"type":20},560,[57],"Söderqvist et al. recently reported on a new school-based program designed to promote mental well-being in adolescents: the Solution-Focused Intervention for Mental Health (SIM, https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.ssmmh.2025.100493). While previous studies on SIM were designed mainly to test, develop, refine and improve the program and its feasibility in a school setting, the current project aims to test the efficacy of SIM on adolescent mental health, primarily mental well-being.\n\nA two-arm, cluster, randomized, controlled trial will be conducted. The intervention group will receive the SIM program, and the control group will receive a lecture on mental well-being along with the usual school provisions. Randomization is done by class because the intervention takes place in mentor groups. Based on the results of our largest feasibility study, 559 students are required for paired measurements to detect a small effect on mental well-being with 80% power and a significance level of 0.05. The evaluation is based on validated instruments, with measurements taken before and after the intervention, as well as six and nine months later. The project is being implemented in collaboration with six upper secondary schools in Sweden. Recruitment and anchoring at the participating schools, as well as class randomization strafied on educational program, took place in 2025. Enrollment of participating students will begin in January 2026.\n\nThis project will contribute new knowledge to the field by evaluating a universal program for schools to use in their health promotion work. The latter is important since high levels of mental well-being independently predict a lower incidence of subsequent mental illness and have a range of positive effects on individuals and society.",[299,300,301,302],"Solution-focused Capability","Mental Well-being","Mental Problems","Perceived Stress",[304,305,306,307,308,309,310,311,312,313,314],"Mental well-being","Solution-focused Intervention for mental health","SIM","School-based intervention","Strength-based","Mental health promotion","Solution-focused coaching","Cluster randomized controlled trial","Adolescents","Solution-focused brief therapy","Universal mental health intervention","2025-08-01",{"date":317,"type":35},"2025-08-08",{"date":319,"type":20},"2026-12-01",{"date":321,"type":20},"2027-10",{"name":41,"class":42},{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":331,"minAge":293,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":55,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":43},"100600041","young-vulvodynia-effect-and-efficacy-of-multimodal-treatment-100600041","NCT07092332","Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.","Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain","UV","Inclusion Criteria:\n\n* Biological sex female\n* 15-23 years of age\n* Diagnosed with Provoked vulvodynia\n\nExclusion Criteria:\n\n* Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)\n* Ongoing pregnancy\n* Childbirth within the last year\n* Post-traumatic stress disorder (PTSD) related to sexual trauma\n* Insufficient mastery of the Swedish language\n* No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment","FEMALE","23 Years",{"count":334,"type":20},15,[57],"The aim of this SCED-study is to evaluate a multimodal treatment for vulvodynia in young women. The main questions it aims to answer are:\n\nIs multimodal treatment effective for provoked vulvodynia in young women? How is multimodal treatment experienced by young women with vulvodynia?\n\nParticipants will respond to frequent questionnaires (two times a week) during a baseline period of 4,5 or 6 weeks, as well as during their treatment period ( a total of 25 weeks). In addition they will respond to pre-, post-treatment and 6 month follow-up questionnaires.",[338],"Vulvodynia",[338,340,341,342,343,344,345,346],"Provoked Vulvodynia","Multimodal Treatment","Cognitive Behavior Therapy","Single-Case Experimental Design","Chronic Pain","Adolescent","Emerging Adulthood","2025-07-22",{"date":349,"type":35},"2025-07-29",{"date":351,"type":35},"2025-06-10",{"date":353,"type":20},"2026-12-31",{"name":41,"class":42},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":362,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":55,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":379},"100530481","interceptive-maxillary-expansion-to-relief-anterior-crowding-in-the-mixed-dentition-100530481","NCT06187337","Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition","Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition: a Longitudinal, Randomized Controlled Trial","Inclusion Criteria:\n\n* Healthy subjects without sucking habits\n* Permanent maxillary central incisors and first permanent molars fully erupted. DS1M1.\n* No severe crowding or protrusion in the lower arch considering the Leeway space and normal development of the arch.\n* Permanent first molar in normal transversal relation.\n* Crowding of the maxillary incisors with the lateral incisor just erupting ectopically or not yet emerged through the gingiva.\n* Crowding greater than or equal to 6 millimeters between the upper deciduous canines.\n\nExclusion Criteria:\n\n* Skeletal asymmetries, anomalies and syndromes.\n* Previous orthodontic treatment","6 Years","16 Years",{"count":54,"type":20},[57],"The goal of this clinical trial is to compare if it is better to treat severe anterior crowding in the early mixed dentition then later in the permanent dentition in children with anterior crowding of the upper teeth. The main questions this trial aims to answer are:\n\n* If there is a difference in the degree of anterior crowding between the experimental group and the control group after a five year follow-up period.\n* If there is a difference between the experimental group and the control group in regard to oral health related quality of life.\n* If there is spontaneous transversal adaption of the lower dental arch to upper dental arch after maxillary expansion and compare this to the control group.\n* If early maxillary expansion is more cost-effective than treatment in the permanent dentition.\n\nTo be eligible for this trial the subject must be children between six and nine years old at the time for inclusion. The children must have crowding of the upper front teeth of six millimeters or more and the lateral incisors should not have erupted or just erupted through the gingiva.\n\nSubjects randomized to the experimental group will get an expansion treatment in the upper jaw with rapid maxillary expansion device to gain enough space for the lateral incisors to erupt. All subjects, also the subjects randomized to the control group, are followed until all permanent teeth have erupted.\n\nAt the end of the follow-up period all subjects fill out a questionnaire to evaluate their oral health related quality of life.\n\nResearchers will then compare the subjects in both groups to evaluate if there is a difference in anterior crowding after the follow-up period. Differences in cost-effectiveness, morphological changes and the subjects oral health related quality of life will also be evaluated.",[368,369,370],"Crowding of Anterior Maxillary Teeth","Orthodontics, Interceptive","Orthodontics, Corrective, Palatal Expansion Technique","2025-07-15",{"date":373,"type":35},"2025-07-18",{"date":375,"type":35},"2021-12-20",{"date":377,"type":20},"2028-01-31",{"name":41,"class":42},4,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":55,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":43},"100366908","phase-4-optimal-electrical-stimulus-during-electroconvulsive-therapy-100366908","NCT04057378","Optimal Electrical Stimulus During Electroconvulsive Therapy","Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial","Inclusion Criteria:\n\n* At least 18 years old at the time of inclusion\n* Fulfilled diagnostic criteria for unipolar, or bipolar depressive episode according to ICD-10.\n* Has indication for and accepts ECT\n* Has a Swedish personal identity number\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n• If the investigator judges a certain pulse width to be inappropriate for the patient.",{"count":388,"type":20},800,[83],"Synopsis\n\nAim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli.\n\nDesign: National, register-based randomized trial, unmasked with two treatment arms.\n\nPrimary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (\\\u003C 11 on the MADRS-S) than a 0.5ms pulse width stimulus.\n\nSecondary objectives include testing for differences in:\n\nself-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm.\n\nInclusion criteria:\n\nAt least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10.\n\nAn indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent.\n\nExclusion criteria:\n\nIf the investigator judges a certain pulse width to be inappropriate for the patient.\n\nInclusion time 2019-05-01-2022-11-15.\n\nAbbreviations\n\n1. CGI: Clinical Global Impression Scale\n2. CPRS: The Comprehensive Psychopathological Rating Scale\n3. ECT: Electroconvulsive therapy\n4. EQ5D: EuroQual-group 5 Dimensions Scale\n5. ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision,\n6. MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version.\n7. Q-ECT: Swedish national quality register for ECT\n8. VAS: Visual analogue scale",[392,393],"Depressive Disorder, Major","Depression, Bipolar","2025-06-17",{"date":396,"type":35},"2025-06-22",{"date":398,"type":35},"2019-10-30",{"date":400,"type":20},"2027-11-15",{"name":41,"class":42},{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":331,"minAge":79,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":55,"phases":412,"briefSummary":413,"conditions":414,"keywords":418,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":102},"100575833","question-prompt-list-in-breast-cancer-patients-planned-for-neoadjuvant-chemotherapy-100575833","NCT06777420","Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy","Question Prompt List as a Tool to Promote Patient-physician Concordance in the Understanding of Information on Neoadjuvant Treatment in Breast Cancer: a Randomized Controlled Trial","QPL","Inclusion Criteria:\n\n* Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.\n\nExclusion Criteria:\n\n* Patients with locally advanced breast cancer where neoadjuvant therapy is mandatory rather than a treatment option.\n* Patients with cognitive impairment that are assessed from treating physician as unable to participate.\n* Patients who cannot speak\u002Fread neither Swedish nor English.",{"count":411,"type":20},218,[57],"Preoperative chemotherapy has been shown to be at least as effective as postoperative chemotherapy in breast cancer patients and has seen increased use over time. The decision regarding neoadjuvant treatment is complex, as various aspects need to be considered, and the patient's role in the decision-making process is central.\n\nThe information provided by doctors to patients about preoperative treatment can be complicated, including details about treatment options, treatment plans, and side effects. If this information is not conveyed adequately, there is a risk of misunderstandings, which can lead to increased anxiety and stress for patients regarding their decisions.\n\nIn oncology, question prompt lists (QPL) have been used as a tool to support patients by improving the information conveyed by doctors in various contexts where complex decisions need to be made. Studies have shown that QPL can facilitate better information exchange. However, their use in discussions about preoperative treatment for breast cancer patients has not been studied. Furthermore, evidence from randomized studies on the use of QPL in clinical practice is very limited.\n\nThe aim of this study is to investigate whether the use of QPL during patient consultations involving discussions about neoadjuvant chemotherapy can improve information exchange in various aspects: understanding of the treatment; anxiety about the decision; participation in the decision-making process; patient-doctor communication; and decision-related conflict.",[415,416,417],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Neoadjuvant Therapy","Shared Decision Making",[419,420,421,422,423],"breast cancer","neoadjuvant therapy","question prompt list","patient-physician communication","shared decision making","2025-04-16",{"date":426,"type":35},"2025-04-20",{"date":428,"type":35},"2025-03-01",{"date":430,"type":20},"2027-02",{"name":41,"class":42},{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":331,"minAge":79,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":55,"phases":443,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":334},"100533275","phase-3-optimizing-extended-adjuvant-endocrine-therapy-in-patients-with-breast-cancer-100533275","NCT06223698","Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer","Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial","SWE-Switch","Inclusion Criteria:\n\nCohort 1 (premenopausal women at diagnosis converted to postmenopausal)\n\n1. Women who were pre- or perimenopausal at diagnosis\n2. Luminal breast cancer (defined as estrogen-receptor positive \\>\u002F=10%, HER2-negative disease).\n3. Treated with tamoxifen for at least 80% of a 5-year period (+\u002F- 6 months from treatment completion).\n4. No clinical signs of metastasis after 5 years tamoxifen treatment.\n5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.\n6. Postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines.\n\nCohort 2 (postmenopausal women at breast cancer diagnosis)\n\n1. Women who were postmenopausal at diagnosis.\n2. Luminal breast cancer (defined as estrogen-receptor positive \\>\u002F=10%, HER2-negative disease).\n3. Treated with AI for at least 80% of a 5-year period (+\u002F- 6 months from treatment completion).\n4. No clinical signs of metastasis after 5 years AI treatment.\n5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.\n\nExclusion Criteria:\n\nCohort 1\n\n1. Prior invasive breast cancer diagnosis.\n2. Other invasive malignancy within 5 years before or after breast cancer diagnosis\n3. Non-luminal breast cancer (defined as estrogen-receptor \\\u003C 10%).\n4. Patients who were unable to complete at least 80% of 5-year initial treatment with tamoxifen.\n5. Uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions).\n6. Recurrent or metastatic breast cancer within or after 5-year initial treatment with tamoxifen (DCIS-only is allowed at any time before or after breast cancer diagnosis).\n\n8\\) Unable to give informed consent in Swedish. Cohort 2\n\n1. Prior invasive breast cancer diagnosis.\n2. Other invasive malignancy within 5 years before or after breast cancer diagnosis; non-Luminal breast cancer (defined as estrogen-receptor \\\u003C 10%).\n3. Patients who were unable to complete at least 80% of 5-year initial treatment with AI.\n4. Recurrent or metastatic breast cancer within or after 5-year initial treatment with AI (DCIS-only is allowed at any time before or after breast cancer diagnosis).\n\n6\\) No contraindication for tamoxifen therapy. 7) Unable to give informed consent in Swedish.","90 Years",{"count":442,"type":20},3832,[444],"PHASE3","Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice.\n\nThe primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios:\n\n* In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen.\n* In postmenopausal women at diagnosis.",[447],"Breast Cancer",[419,449,450,451],"adjuvant therapy","endocrine treatment","extended therapy",{"date":426,"type":35},{"date":454,"type":20},"2025-05-02",{"date":456,"type":20},"2035-05-02",{"name":41,"class":42},{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":55,"phases":467,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":484},"100504774","phase-3-sglt2-inhibitor-treatment-in-patients-awaiting-coronary-artery-bypass-surgery-to-reduce-post-operative-af-100504774","NCT05852704","SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF","SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative Atrial Fibrillation and Kidney Injury (STENOTYPE Trial)","STENOTYPE","Inclusion Criteria:\n\n* Written informed consent.\n* Patients aged 18 years or older.\n* Chronic coronary syndrome scheduled for elective isolated CABG surgery with extra corporeal circulation, or elective CABG surgery with extra corporeal circulation combined with aortic valve replacement, mitral valve surgery, and \u002F or aortic root surgery.\n\nExclusion Criteria:\n\n* Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment.\n* Intolerance, hypersensitivity, or other contraindications of dapagliflozin.\n* Type 1 diabetes mellitus.\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg at two out of three measurements at enrolment.\n* Current acute decompensated heart failure or hospitalization due to decompensated heart failure \\\u003C4 weeks prior to enrolment.\n* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy.\n* Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment.\n* Stroke or transient ischemic attack within 12 weeks prior to enrolment.\n* Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment.\n* Any condition such as, but not limited to, malignancy, with a life expectancy of \\\u003C2 years based on the investigator's clinical judgement.\n* Hepatic impairment (aspartate transaminase or alanine transaminase \\>3 × the upper limit of normal, or total bilirubin \\>2 × upper limit of normal at the time of enrolment).\n* Severe (estimated glomerular filtration rate \\\u003C 25 mL\u002Fmin\u002F1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment.\n* CABG surgery planned within one week.\n* Emergency surgery with hemodynamic instability.\n* Previous history of AF.\n* Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile\\*)\n\n  1. Who are not willing to use a highly effective method of contraception\\*\\* judged by the investigator, from the time of signing the informed consent throughout the trial and 4 weeks thereafter, OR\n  2. Who have a positive pregnancy test at enrolment or randomization, OR\n  3. Who are breast-feeding.\n* Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days before randomization.\n* Previous randomization in the STENOTYPE trial.\n* Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed.\n* Mental inability, reluctance, or language difficulties of the subject, in the opinion of the investigator, that result in difficulty in understanding the meaning of participation in the trial.",{"count":388,"type":20},[444],"The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and\u002For acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are:\n\n* Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of new onset atrial fibrillation compared to placebo?\n* Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of acute kidney injury before hospital discharge compared to placebo?\n\nParticipants will be administered dapagliflozin 10 mg once daily or placebo for a minimum of seven days while awaiting scheduled CABG and up until discharge, with a short interruption for surgery. The active arm will be compared to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and\u002For acute kidney injury.",[470,471],"Chronic Coronary Syndrome","Atrial Fibrillation",[473,474,475],"Atrial fibrillation","Acute Kidney Injury","Coronary artery bypass grafting","2025-04-04",{"date":478,"type":35},"2025-04-08",{"date":480,"type":35},"2024-04-04",{"date":482,"type":20},"2028-12-04",{"name":41,"class":42},8,{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":331,"minAge":363,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":55,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":4},"100584990","telemedicine-for-contraceptive-counselling--an-open-randomized-controlled-trial-100584990","NCT06896539","Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial","Tele-health for Contraceptive Counselling - a Randomized Controlled Trial of Contraceptive Counselling Via Tele-health Compared to Standard Routine on the Effects of Choice and Uptake of LARC","Tele-prev","Inclusion Criteria:\n\n* Women aged 16-40 years\n* Primary reason for use of contraception being pregnancy prevention\n* Not having pregnancy intentions within 6 months.\n* Sufficient language skills to understand the study information available in Swedish and English.\n\nExclusion Criteria:\n\n* Women in need for contraceptive method for medical reasons other than protection against unintended pregnancy.","40 Years",{"count":495,"type":20},772,[57],"Protocol Summary:\n\nSweden has high unintended pregnancy rates, increasing unmet contraceptive needs, and the highest repeat abortion rate in the European Union. Effective contraceptive counseling can improve satisfaction, empower correct use, and increase uptake of long-acting reversible contraceptives (LARC), potentially reducing unintended pregnancies.\n\nResearch has explored ways to enhance contraceptive counseling, focusing on increasing LARC use. Interventions that improve access, remove financial barriers, and enhance method-specific knowledge-especially regarding effectiveness-have led to higher LARC adoption and fewer unintended pregnancies and abortions.\n\nThe COVID-19 pandemic significantly increased tele-health use for contraceptive counseling. Studies suggest tele-health expands appointment availability, reduces geographic barriers, and improves access to reproductive care, particularly in low-resource populations. However, few studies have examined tele-health's impact on contraceptive counseling, uptake, and satisfaction compared to in-person visits, particularly in Sweden. Before tele-health can be established as a viable family planning option, its counseling quality and impact on LARC adoption must be assessed.\n\nStudy Aims:\n\nTo determine whether the choice of LARC after tele-health (video) counseling is comparable to in-person counseling with a midwife, using structured contraceptive counseling in both groups.\n\nTo assess whether LARC uptake three months post-counseling is similar between women who received tele-health vs. in-person counseling.\n\nThis study will provide valuable insights into tele-health's role in contraceptive counseling and its potential to improve access to family planning services.",[499],"Unintended Pregnancy Prevention",[501,502,503,504],"Telemedicine","Contraception","Unintended pregnancy","Counselling","2025-03-19",{"date":507,"type":35},"2025-03-26",{"date":509,"type":20},"2025-04-01",{"date":511,"type":20},"2029-06-30",{"name":41,"class":42},{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":55,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":43},"100495013","hot-water-immersion-after-myocardial-infarction-100495013","NCT05725655","Hot Water Immersion After Myocardial Infarction","Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study","HOT-MI","Inclusion criteria\n\n* Patients with a diagnosis of ST-elevation myocardial infarction (STEMI) or non-STEMI\n* Concomitant participation in standard care exercise-based cardiac rehabilitation\n* Male or female patients ≥ 18 years\n* Written informed consent\n\nExclusion criteria\n\n* Regularly performing hot water immersion, sauna or other types of thermotherapy\n* Not willing to perform hot water immersion regularly\n* Febrile illness or acute, ongoing infection\n* \\\u003C18 years of age\n* Inability to provide informed consent",{"count":522,"type":20},30,[57],"Myocardial infarction (MI) is a leading cause of death in developed countries, including Sweden. Standard treatment for patients after MI includes exercise-based cardiac rehabilitation which contributes to improved cardiovascular function and reduces the risk of hospital readmissions, new cardiovascular events and mortality. Thermotherapy may also have beneficial effects on cardiovascular disease by a reduction in inflammatory status and improved metabolism and vascular function. Given the well-documented effects of exercise training on cardiac rehabilitation and recent evidence that thermotherapy may improve cardiovascular function, we wish to investigate the effect of exercise combined with hot water immersion (HWI) in cardiac rehabilitation post-MI.\n\nThis is a single-centre, randomized controlled clinical trial in patients with recent MI. Our aim is to investigate whether exercise training combined with HWI improves inflammatory and metabolic status, cardiovascular function as well as psychological well-being, compared with exercise training alone. Patients will be randomized 1:1 to an 8 week intervention with exercise training 2 times per week followed by 15 minutes of hot water immersion, or to a control group with exercise training alone. The primary endpoint is changes in the inflammatory marker interleukin (IL-) 6 between groups at 8 weeks. Secondary endpoints include other biomarkers of inflammation, metabolism, effects on cardiovascular function and psychological benefits.\n\nSecondary prevention after MI has improved during the last decades but readmissions and death following acute MI remain large health challenges. If HWI in addition to standard cardiac rehabilitation can lower inflammation more than standard therapy alone, and improve metabolic, cardiovascular and psychological status, it could be a cost-effective and safe complementary strategy for secondary prevention after MI, particularly for those with limited exercise capability.",[526,527],"Cardiac Disease","Cardiac Rehabilitation","2025-02-11",{"date":530,"type":35},"2025-02-14",{"date":532,"type":35},"2023-10-26",{"date":534,"type":20},"2025-12-31",{"name":41,"class":42},{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":544,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":55,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":43},"100577069","reablement-in-residential-aged-care---a-randomized-controlled-trail-100577069","NCT06793501","Reablement in Residential Aged Care - a Randomized Controlled Trail","A Reablement Intervention in Residential Aged Care (Re-RAC): Study Protocol for a Multi-center, Pragmatic Randomized Controlled, Open-label Trial","Re-RAC","Inclusion Criteria: Older adults aged 65 years and above, residing in a somatic ward at one of the RAC facilities where the study will be conducted, and meeting the inclusion criteria, are eligible to participate in the study. The inclusion criteria require that the older adult must be able to engage in conversations in Swedish and be able to participate in both the assessments and the intervention.\n\nExclusion Criteria: Persons having severe cognitive impairment (≤17) according to Mini Mental State Examination-Swedish version (MMSE-SR; screening for cognitive function) or being very severely frail or terminally ill according to Clinical Frailty Scale (≥8) (CFS-9) will be excluded.","65 Years",{"count":546,"type":20},84,[57],"Background: The global increase in older adults presents challenges for maintaining health and autonomy in residential aged care (RAC) facilities, where passivity has been shown to often diminish quality of life. However, the reablement approach, which enhances independence through personalized, multidisciplinary strategies, shows promise for addressing these issues and requires further evaluation, particularly in Swedish contexts.\n\nThe research project Reablement in RAC (Re-RAC) aims to evaluate the impact of the Re-RAC intervention on activity performance and satisfaction, participation, quality of life and well-being, and health economic outcomes for older adults in RAC facilities, while also describe participant and staff experiences.\n\nMethods: This study is a multi-center prospective pragmatic randomized controlled trial with two parallel groups that will evaluate the Re-RAC intervention compared to treatment as usual, using quantitative, qualitative and health economic methods.\n\nThe Re-RAC intervention begins with an interview according to Canadian Occupational Performance Measure (COPM) to identify a meaningful goal, followed by a personalized support plan with training activities, supported by nursing staff. The intervention lasts 8 weeks, with adjustments made based on progress, and ends with a COPM reassessment of the participant's performance and satisfaction. Eighty-six participants will be included, assessed for performance (COPM-performance), satisfaction (COPM-satisfaction), health-related quality of life (EQ-5D-5L), psychological well-being (WHO-5), and physical activity levels (measured by an accelerometer), before and after the intervention. Pain will also be assessed for potential associations with other outcomes. Participants' and staff's experiences will be described through interviews, and cost-effectiveness will be evaluated by calculating the cost per quality adjusted life-years gained.\n\nDiscussion: The Re-RAC project evaluates the impact of a reablement intervention on activity performance, satisfaction, quality of life, well-being, and health outcomes for older adults in RAC facilities through a pragmatic randomized controlled trial, with assessments before and after the 8-week intervention. The study also explores participant and staff experiences and evaluates cost-effectiveness. The results of this study will offer valuable insights to inform the future implementation and assessment of reablement interventions in RAC settings.",[550],"Older People","2025-01-20",{"date":553,"type":35},"2025-01-27",{"date":555,"type":35},"2024-10-10",{"date":557,"type":20},"2026-08-31",{"name":41,"class":42},{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":16,"minAge":567,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":55,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":585},"100519521","phase-3-implementing-geriatric-assessment-for-dose-optimization-of-cyclin-dependent-kinase-cdk-46-inhibitors-in-older-breast-cancer-patients-100519521","NCT06044623","Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4\u002F6-inhibitors in Older Breast Cancer Patients","Implementing Geriatric Assessment for Dose Optimization of CDK 4\u002F6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)","IMPORTANT","Inclusion Criteria:\n\nThe following inclusion criteria will be applied:\n\n1. Patients male or female aged at least 70 years old at the time of informed consent.\n2. Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory.\n3. Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.\n4. No prior systemic treatment for advanced disease (recurrence during neo-\u002Fadjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4\u002F6-inhibitor initiation is allowed.\n5. Adjuvant treatment with CDK 4\u002F6-inhibitors is allowed provided a disease-free interval from treatment end \\>12 months.\n6. Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1.\n7. Written informed consent prior to any study-specific procedures.\n8. Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4\u002F6-inhibitors that is planned to be used.\n9. Able to swallow capsules.\n10. Able to understand and consent in English language or in native language for each participating country.\n\nExclusion Criteria:\n\nEligible patients will be excluded if they have one of the following criteria:\n\n1. Patients considered from treating physician as non-suitable for treatment with CDK 4\u002F6-inhibitors.\n2. Contraindications according to SmPC for the CDK 4\u002F6-inhibitors that is planned to be used.\n3. Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.\n4. History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.\n5. Participating in other interventional trial.","70 Years",{"count":569,"type":20},495,[444],"IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive\u002Fhuman epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4\u002F6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4\u002F6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4\u002F6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.\n\nOn the basis of baseline CGA assessment, patients will either receive full dose of CDK 4\u002F6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4\u002F6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.\n\nThis project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.",[573,574,26,575,576],"Metastatic Breast Cancer","Advanced Breast Cancer","Toxicity","Older Patients","2024-11-15",{"date":579,"type":35},"2024-11-19",{"date":581,"type":35},"2024-04-01",{"date":583,"type":20},"2029-05-31",{"name":41,"class":42},12,{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":15,"sex":16,"minAge":593,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":55,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":230},"100426062","retention-with-three-different-bonded-retainers-a-multicenter-randomized-controlled-trial-with-5-year-follow-up-100426062","NCT04828096","Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up","Retention With Three Different Bonded Retainers: a Multicenter, Randomized Controlled Trial With 5-year Follow-up","Inclusion Criteria:\n\n* Patients requiring mandibular lingual fixed canine-to-canine retainer after undergoing orthodontic treatment with fixed appliances\n* Sound enamel on the lingual surface\n* Calculus-free lingual surface in the lower anterior segment\n\nExclusion Criteria:\n\n\\-","10 Years","60 Years",{"count":596,"type":20},324,[57],"One of major challenges in orthodontics is to inhibit relapse and ensure stability of treatment outcomes. Retention is the phase of orthodontic treatment that attempts to keep teeth in the corrected position after correction with orthodontic braces. Without retention there is a tendency for the teeth to return to their initial position (1). Retention is usually necessary to overcome the elastic recoil of the periodontal supporting fibers and to allow remodeling of the alveolar bone. The bonded orthodontic lingual retainer constructed from composite and orthodontic wires provides an esthetic and efficient system for maintained retention and has been shown to be an effective means of retaining aligned anterior teeth in the post treatment position in the long term. This has been in popular use as a method of retention since the late 1970s (2).\n\nThe traditional retainers, which are still in use, are multi-strand stainless steel retainers such as Penta-one® 0.0215 (Masel Orthodontics, Carlsbad, CA, USA). The main problem with multistrand stainless steel retainers is their high rate of failure. Clinical studies indicate that 5% to 37% of mandibular retainers fail during retention in some form, either bond failure or wire breakage (3-5). Reliance Orthodontic Products, Inc. (Itasca, IL, USA) recently introduced a bonded retainer system (Ortho-Flextech™ chain). This retainer's bonding is claimed to be quick and easy by reducing chairside time and eliminating laboratory costs (6). One other recently introduced retainer is Memotain™ (CA-Digital in Mettmann, Germany). Memotain is a CAD\u002FCAM fabricated lingual retainer made of 0.014 X 0.014-inch rectangular nickel-titanium. The wire is highly flexible and custom cut to precisely adapt to the patient's lingual tooth anatomy. According to manufacturer, Memotain offers numerous perceived advantages to traditional multistranded lingual wires, including no need for wire measuring or bending, individually optimized placement, greater accuracy of fit, tighter interproximal adaptation, less tongue irritation, better durability, and resistance to microbial colonization (6). However, randomized clinical trials are necessary to determine whether these advantages are substantiated with scientific data.\n\nA recent review by the Cochrane group concluded that to date there is insufficient evidence to single out any particular retention strategy as the preferred method: it was recommended that future studies should include true randomization, reporting of dropouts, adequate sample size calculation, and a minimum follow-up period of 3 months (8). Thus, the aims of this multicenter, randomised controlled trial are:\n\n* To compare and evaluate the effectiveness and failure rate of Penta-one multistrand, Ortho-Flextech and Memotain retainers with each other\n* To compare the possible complications between the three retainers over time\n* To establish the cost-effectiveness of the three retainers\n* To evaluate the effectiveness of sandblasting in the retention of the wires",[600,601],"Dental Malocclusion","Stability",[603],"Orthodontic retention, Stability, Long-term","2023-09-05",{"date":606,"type":35},"2023-09-08",{"date":608,"type":35},"2021-03-25",{"date":610,"type":20},"2026-09-30",{"name":41,"class":42},{"id":613,"slug":614,"hasResults":11,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":619,"enrollmentInfo":620,"targetDuration":4,"studyType":55,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":640},"100511410","phase-3-first-line-cryoablation-for-early-treatment-of-persistent-atrial-fibrillation-100511410","NCT05939076","First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation","First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication","Inclusion Criteria:\n\n* Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months, the latest episode within the previous 6 months and one documented on a 12 lead ECG or Holter monitor, that is classified as either\n\n  1. Classical persistent AF (continuously sustained beyond 7 days and \\\u003C12 months in duration) as defined by ESC guidelines14 OR\n  2. Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion to sinus rhythm is lacking during the past 24 months).\n* Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF.\n\nExclusion Criteria:\n\n1. Regular daily use of AAD class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted).\n2. Previous AF ablation or surgery.\n3. Severe heart failure (NYHA III-IV).\n4. Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm).\n5. Hypertrophic cardiomyopathy (septal or posterior wall thickness \\>1.5 cm)\n6. Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml\u002Fm2) \\> 48.\n7. Significant valvular disease requiring treatment or valve prothesis.\n8. Severe Chronic Obstructive Pulmonary Disease (COPD) stage III or chronic kidney disease (eGFR\\\u003C 30 umol\u002Fl)).\n9. Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.\n10. Myocardial infarction, revascularisation previous 6 months.\n11. Stroke or Transient Ischemic Attack (TIA) within previous 6 months.\n12. Tachycardiomyopathy.\n13. Dependent on VVI (ventricular single chamber inhibited) pacing.\n14. Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.\n15. Expected survival less than 3 years, alcohol or drug abuse.\n16. Participation in another trial or absence of consent.","75 Years",{"count":266,"type":20},[444],"The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question\\[s\\] it aims to answer are:\n\n* Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting \\> 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF?\n* Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF\u002FAT burden, AF\u002FAT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular;\n\n  * Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor,\n  * Regular echocardiographic exams for reverse atrial remodelling assessment,\n  * HRQoL questionnaires\n  * Assessment of cognitive function\n  * Atrial fibrillation evaluation regarding structured characterisation and AF progression\u002Fregression\n  * Assessment of Health care use and costs\n  * Safety",[624],"Atrial Fibrillation, Persistent",[626,627,628,629,630,631],"atrial fibrillation","ablation","first-line","antiarrhythmics","burden","symptoms","2023-07-02",{"date":634,"type":35},"2023-07-11",{"date":636,"type":20},"2023-08-21",{"date":638,"type":20},"2028-12",{"name":41,"class":42},6,{"id":642,"slug":643,"hasResults":11,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":15,"sex":16,"minAge":79,"maxAge":544,"enrollmentInfo":648,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":650,"conditions":651,"keywords":654,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":43},"100453520","assessment-of-anorectal-function-in-patients-with-inflammatory-bowel-disease-100453520","NCT05185609","Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease","Assessment of Anorectal Function in Healthy Volunteers and Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Healthy volunteers\n* Symptomatic IBD patients: Moderate to severe IBD in remission with persistent symptoms as reported by symptom index and short health scale.\n* Asymptomatic IBD patients: moderate to severe IBD in remission without symptoms\n\nExclusion Criteria:\n\nHealthy volunteers:\n\n* gastrointestinal disease, functional gastrointestinal symptoms,\n* psychiatric disease\n* anal or pelvic surgery, inclusive interventions during delivery\n* diabetes, cardiovascular, renal, or hepatic disease,\n* concurrent or recent treatment with drugs affecting intestinal function or mood (antidepressants), nutritional supplements or herb products affecting intestinal function (probiotics), abuse of alcohol or drugs, and a recent (\\\u003C 2 weeks) history of systemic steroid therapy.\n\nIBD patients\n\n* active disease\n* anal or pelvic surgery, inclusive interventions during delivery\n* diabetes, cardiovascular, renal, or hepatic disease,\n* concurrent or recent treatment with drugs affecting intestinal function or mood (antidepressants), nutritional supplements or herb products affecting intestinal function (probiotics), abuse of alcohol or drugs, and a recent (\\\u003C 2 weeks) history of systemic steroid therapy. Patients taking antidiarrhoeal or laxatives can be included after a 48 h washout period.",{"count":649,"type":20},70,"Active inflammatory bowel disease (IBD) causes disabling symptoms such as diarrhea, involuntary loss of bowel control, abdominal pain and urges to pass stool. However, even patients with inactive IBD frequently experience such symptoms. The cause is not well understood and the functionality of the bowel in IBD patients is underexplored.\n\nEarlier studies show a wide range of results, but most find that patients with IBD in remission are up to four times as likely to report gastrointestinal symptoms when compared to healthy controls.\n\nChronic inflammation may cause changes of the bowel wall, like increased collagen deposits (fibrosis) and thus cause symptoms, but the absence of active inflammation in combination with presence of symptoms may also be regarded as resembling the clinical condition of irritable bowel syndrome (IBS).\n\nIBS is characterized by abdominal pain and changes in stool frequency and consistence and is often associated with disorders like depression and anxiety. Up to a third of IBD patients without signs of disease activity meet the criteria for IBS (irritable bowel syndrome. It can be speculated that an IBD diagnosis is a distressing event that can induce mood disorders, and an IBS-like condition.\n\nCharacterization of IBS patients relies on the Rome IV symptom criteria, symptom severity scales and measurements of rectal sensibility and rectal compliance using a barostat procedure.\n\nMotor function assessment relies on anorectal manometry which detects abnormalities of muscle function and coordination. Recently, a standardized high-resolution anorectal manometry protocol (HRAM) was published which also evaluates sensitivity and compliance. The level of agreement between the barostat method and the HRAM testing procedure regarding sensibility and rectal compliance is largely unknown.\n\nRecent studies have associated gut microorganisms, genetic factors, and proteins with various aspects of IBD. There is evidence that these potential markers may reflect non-inflammatory processes such as fibrosis.\n\nThe aim of this study is to explore the anorectal function in symptomatic patients with inactive IBD compared to healthy volunteers and asymptomatic patients, evaluate symptom severity and psychological parameters and perform molecular characterization.\n\nThe level of agreement of rectal sensitivity and compliance measurements with the barostat method and HRAM protocol will also be evaluated.",[652,653],"Inflammatory Bowel Diseases","Irritable Bowel Syndrome",[655,656,657],"Anorectal function","Anorectal manometry","Rectal barostat","2022-01-19",{"date":660,"type":35},"2022-02-03",{"date":662,"type":35},"2021-09-01",{"date":664,"type":20},"2027-12-30",{"name":41,"class":42},""]