[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Karolinska Institutet\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":657},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,230,0,25,[9,43,70,99,120,144,164,193,217,240,273,296,323,346,374,400,432,457,478,504,533,559,583,609,632],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100478706","ethnic-and-gender-based-admittance-patterns-in-the-icu-100478706",false,"NCT05513456","Ethnic and Gender Based Admittance Patterns in the ICU","Ethnic and Gender Based Admittance Patterns in the ICU, a Multicenter, International Randomized Survey Study","EGAP-ICU","Inclusion Criteria:\n\nWe will include intensive care physicians, both in training and specialists as responders in this randomized survey study\n\nExclusion Criteria:\n\nWe will exclude \"button-mashers\", i.e. participating respondents that toggle through the case descriptions faster than they possibly could read the case description. A case answered \\\u003C20 seconds will be ruled out.",true,"ALL",{"count":21,"type":22},5000,"ESTIMATED","OBSERVATIONAL","The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown.\n\nFactors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity.\n\nThis study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons?\n\nThe investigators propose testing this hypothesis using a blinded randomized factorial survey study.",[26,27,28,29],"Critical Illness","Gender Equality","Discrimination, Sex","Discrimination, Racial","RECRUITING","2026-08-18",{"date":33,"type":34},"2026-08-20","ACTUAL",{"date":36,"type":34},"2024-05-31",{"date":38,"type":22},"2026-12",{"name":40,"class":41},"Karolinska Institutet","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100652334","evaluating-the-feasibility-and-effects-of-puls-100652334","NCT07772128","Evaluating the Feasibility and Effects of PULS","Evaluating the Feasibility and Effects of PULS: A Cognitive Behavioral Treatment for Youth Involved in Criminal Groups in Swedish Institutional Care","PULS on SiS","Inclusion Criteria:\n\n* placed at SiS with documented criminality as a basis for placement in institutional care\n\nExclusion Criteria:\n\n* extensive cognitive impairment that prevents the youth from benefiting from treatment and\u002For medical or psychiatric conditions that require emergency care.","16 Years","21 Years",{"count":54,"type":22},224,"INTERVENTIONAL",[57],"NA","Background Youth involved in criminal groups represent a growing, high-risk population within Swedish institutional care, with elevated rates of recidivism and poor long-term outcomes. Cognitive behavioral programs show promise in reducing reoffending, but evaluation research in institutional youth care, especially randomized controlled trials, remains scarce. PULS, a cognitive behavioral treatment targeting prosocial behavior, criminal attitudes, and recidivism, is implemented across the institutional youth care institutions in Sweden (SiS) but has not been scientifically evaluated.\n\nAim This project evaluates the feasibility and effects of PULS among youth aged 16-21 in SiS institutional care, with a focus on youth involved in criminal groups, and examines mechanisms maintaining antisocial behavior.\n\nMethods Four studies are conducted: a within-group feasibility study (N≈50) assessing implementation and preliminary effects; a qualitative interview study (N≈30) exploring youth and therapist perceptions; a multicenter randomized controlled trial (target N=224) comparing PULS plus treatment as usual to treatment as usual alone, evaluating effects on behavioral problems, prosocial behavior, and recidivism up to 24-month follow-up; and a diagnostic study assessing psychiatric comorbidity and its association with outcomes. Data are collected via standardized instruments, diagnostic interviews, and national registers, analyzed primarily using Linear Mixed Models and time-to-event analyses.\n\nSignificance This project provides the first scientific evaluation of PULS and is one of the few randomized trials in Swedish institutional youth care, informing future intervention development for youth involved in criminal groups.",[60],"Anti Social Behavior","NOT_YET_RECRUITING","2026-08-17",{"date":64,"type":34},"2026-08-19",{"date":66,"type":22},"2027-01-01",{"date":68,"type":22},"2029-12-30",{"name":40,"class":41},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":19,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":55,"phases":82,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100648201","group-treatment-for-self-harming-adolescents-and-their-parents-a-randomized-controlled-trial-100648201","NCT07720063","Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial","A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)","ERA","Inclusion Criteria:\n\n* Age: 13 - 17 years\n* At least 5 instances of NSSI in the past year, and at least one during the past month\n* ≥5 episodes of NSSI in the past year, including ≥1 in the past month\n* If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion\n* At least one participating caregiver\n* Sufficient Swedish language proficiency (adolescent and caregiver)\n* Regular access to a smartphone for SMS-based assessment\n\nExclusion Criteria:\n\n* Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol\u002Fsubstance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)\n* Acute suicide risk (i.e., current suicide plans) or recent suicide attempt\n* Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months\n* Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)\n* Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and\u002For neglect in the family, inpatient care)\n* Ongoing structured psychological treatment targeting NSSI","13 Years","17 Years",{"count":81,"type":22},180,[57],"Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.\n\nThe overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.",[85,86,87,88,89],"Self-Harm","Self-Harm, Deliberate","Self-harm Behavior","Non-Suicidal Self Injury","Non-suicidal Self-injury (NSSI)",[91,92,93],"emotion regulation group therapy","non-suicidal self-injury (NSSI)","randomized controlled trial",{"date":31,"type":34},{"date":62,"type":22},{"date":97,"type":22},"2034-12-31",{"name":40,"class":41},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":55,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":42},"100622338","metacognitive-therapy-compared-to-cognitive-behavioral-therapy-100622338","NCT07382323","Metacognitive Therapy Compared to Cognitive-behavioral Therapy","Transdiagnostic Metacognitive Therapy Compared to Disorder-specific Cognitive-behavioral Therapy for Anxiety Disorders: a Qualitative Study","Inclusion Criteria:\n\n* Age 18 years or older,\n* A principal diagnosis of generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder,\n* No change in dose during the last six weeks if on pharmacological treatment, and\n* Ability to read and speak Swedish.\n\nExclusion Criteria:\n\n* A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,\n* Acute suicide risk, or\n* Concurrent psychological treatment.","18 Years",{"count":108,"type":22},30,[57],"This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.",[112,113,114],"Generalized Anxiety Disorder","Social Anxiety Disorder","Posttraumatic Stress Disorder (PTSD)",{"date":31,"type":34},{"date":117,"type":34},"2026-01-28",{"date":38,"type":22},{"name":40,"class":41},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":42},"100605468","the-time-before-the-crime---risk-patterns-in-offenders-undergoing-a-forensic-psychiatric-evaluation-100605468","NCT07162909","The Time Before the Crime - Risk Patterns in Offenders Undergoing a Forensic Psychiatric Evaluation","The Time Before the Crime: Risk Patterns in Individuals Who Commit Criminal Acts and Undergo a Forensic Psychiatric Evaluation","Tibec","Inclusion criteria, case group:\n\n* Age ≥ 18 years\n* Contact with a psychiatric care provider within Region Stockholm\n* Medical records requested by the NBFM in 2023 for forensic psychiatric evaluation\n\nInclusion criteria, control group:\n\n* Age ≥ 18 years\n* Contact with a psychiatric care provider within Region Stockholm\n* Medical records NOT requested by the NBFM in 2023 for forensic psychiatric evaluation\n\nMatching criteria:\n\n* Gender (male\u002Ffemale)\n* Age group (18-24, 24-39 and \\>39 years)\n* Psychiatric care unit\n\nExclusion Criteria, general:\n\n* No registered psychiatric care contact in Region Stockholm's shared electronic medical record system, three months prior to the date of the index offense.\n\nExclusion Criteria, case group:\n\n* The index offense before 2018.\n\nExclusion Criteria, control group:\n\n* Individual previously underwent an FPE at some point.",{"count":129,"type":22},500,"The overarching aim of the research project is to identify risk patterns preceding criminal acts among individuals later subject to forensic psychiatric evaluation (FPE) in Sweden, including factors within psychiatric care as well as broader individual or contextual factors.\n\nAlthough individuals who undergo an FPE represent a small subset of all individuals who commit criminal acts, the implications of being sentenced to forensic psychiatric care are profound. In Sweden, approximately 300 individuals are transferred to forensic psychiatric care each year, with a median duration of 7.5 years. Notably, the number of admissions exceeds the number of discharges annually, resulting in a growing forensic psychiatric population. This increasing trend underscores the need for increased knowledge and preventive efforts. All forensic psychiatric patients undergo an FPE before the sentencing, and previous studies show that most of these individuals were already known to the psychiatric system prior to the offenses, which means that individuals in these groups are overlapping. However, the mean length of stay in psychiatric inpatient compulsory care is much shorter than that in forensic psychiatric care. Clinical expertise from FPEs suggests that identifiable risk patterns may exist before the criminal offence. The question of whether such potential risk patterns exist within this patient group has not been systematically studied before, which is why the current study aims to investigate this issue. Can risk patterns be identified within psychiatric care prior to the offense? If risk patterns can be identified, knowledge of such risk patterns could hopefully increase risk awareness within psychiatric services and lead to more frequent and accurate violence risk assessments. Knowledge of such risk patterns could also serve as a foundation for preventive measures. The long-term goal is to reduce the likelihood that individuals receiving psychiatric care progress to becoming forensic psychiatric patients.",[132],"Crime",[134,135,136,137],"severe mental disorder","forensic psychiatric evaluation","risk patterns","violence",{"date":64,"type":34},{"date":140,"type":34},"2026-06-01",{"date":142,"type":22},"2027-12-31",{"name":40,"class":41},{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":55,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":42},"100636607","brief-cognitive-behaviour-therapy-to-prevent-suicide-reattempts-a-feasibility-study-in-swedish-psychiatric-inpatient-care-100636607","NCT07567885","Brief Cognitive Behaviour Therapy to Prevent Suicide Reattempts: A Feasibility Study in Swedish Psychiatric Inpatient Care","BCBT","Inclusion Criteria:\n\n* admitted following a suicide attempt within one week of admission or presenting with suicidal ideation with a plan and a prior suicide attempt within the last two years\n* 18 years or older\n\nExclusion Criteria:\n\n* current mania, current acute psychosis, or cognitive impairment\n* expected inpatient stay shorter than four working days\n* ongoing or planned electroconvulsive therapy\n* psychiatric or somatic conditions leading to inability to provide informed consent",{"count":152,"type":22},32,[57],"The goal of this study is to determine whether Brief Cognitive Behaviour Therapy (BCBT), a four-session psychological treatment aimed at reducing suicide attempts, is acceptable and feasible to deliver during psychiatric inpatient care for adults who have been hospitalised following a suicide attempt or who are at high risk of suicide. The main questions it aims to answer are:\n\n1. Is BCBT acceptable among suicidal psychiatric inpatients, and in what ways can the treatment and its delivery be improved to enhance patient engagement and adherence?\n2. Is BCBT feasible from the perspectives of treating clinicians, clinic managers, and other relevant personnel, and what are the key facilitators and barriers to its implementation within routine inpatient psychiatric care in Sweden?\n\nParticipants will:\n\n* Receive four structured BCBT therapy sessions delivered during hospitalisation, in addition to usual care\n* Be contacted for follow-up assessments at 1 and 3 months after completing treatment\n* Take part in an interview about the participants' experience with the treatment 1 month after completing it\n\nClinical staff, treating psychologists, and managers will also be interviewed to explore the participants' experiences, as well as barriers and facilitators to implementation. Overall, the findings from this study will inform the design of a future randomised trial to test the effectiveness of BCBT in reducing suicide attempts after discharge from inpatient psychiatric care.",[156],"Suicide Attempt","2026-08-13",{"date":62,"type":34},{"date":160,"type":34},"2026-05-11",{"date":162,"type":22},"2027-12-14",{"name":40,"class":41},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":55,"phases":174,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100582923","omission-of-axillary-lymph-node-dissection-in-case-of-tumor-spread-to-lymph-nodes-in-the-armpit-in-breast-cancer-100582923","NCT06869629","Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer","SENOMAC-ULTRA: A Prospective Randomised Trial on the Omission of Axillary Lymph Node Dissection in Ultrasound-detectable Axillary Metastases in Primary Breast Cancer Treated by Upfront Surgery","SENOMAC-ULTRA","Inclusion Criteria:\n\n* Patients with primary invasive breast cancer clinical stage II-III\n* Palpable or non-palpable axillary metastases visible by ultrasound (other imaging accepted if confirmatory ultrasound is performed) and confirmed by fine needle aspiration or core biopsy\n* Written informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Distant metastases\n* Ipsilateral metastases in internal mammary, infra- or supraclavicular lymph nodes without confirmed axillary nodal involvement\n* Preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease\n* Nodes fixed to each other or to neighbouring structures on palpation or imaging\n* History of contralateral invasive breast cancer within 5 years\n* Bilateral invasive breast cancer if (i) one side meets any exclusion criteria or (ii) both sides meet all inclusion criteria\n* Pregnancy\n* Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy \\\u003Cthree months is allowed)\n* Medical contraindications for or expressed preoperative wish to abstain from radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration\n* Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia",{"count":173,"type":22},1380,[57],"SENOMAC-ULTRA enrols patients who are planned for upfront surgery for a breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node\u002Fs in the armpit (the sentinel lymph node\u002Fs) and the known metastatic lymph nodes (targeted axillary dissection, TAD), offers non-inferior survival outcomes to a full axillary lymph node dissection.",[177,178,179],"Breast Carcinoma","Breast Cancer","Breast Surgery",[181,182,183,184,185],"axillary metastases","axillary lymph node dissection","targeted axillary dissection","sentinel lymph node biopsy","axillary ultrasonography",{"date":62,"type":34},{"date":188,"type":34},"2026-05-13",{"date":190,"type":22},"2041-12-31",{"name":40,"class":41},4,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":55,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":42},"100577950","transdiagnostic-online-cbt-vs-care-as-usual-for-primary-care-patients-with-subsyndromal-mental-ill-health--primarita-2--100577950","NCT06804954","Transdiagnostic Online CBT vs. Care as Usual for Primary Care Patients With Subsyndromal Mental Ill-health ( PRIMARITA-2 )","Internet-based Transdiagnostic Cognitive Behavior Therapy and Care as Usual for Primary Care Patients With Mental Ill-health (RCT-2: Subsyndromal Mental Ill-health)","PRIMARITA-2","Inclusion Criteria:\n\nTo be included patients have to:\n\n1. To be included patients have to: (a) have a subsyndromal mental health problem concerning anxiety, depressive symptoms, or stress-related ill-health that warrants treatment,\n2. be at least 18 years old,\n3. have regular access to a device with an Internet connection,\n4. be able to read and write in Swedish,\n5. have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa,\n6. if on medication with monoamine agonist, have stable dosage in the past month,\n7. have no on-going psychological treatment, and\n8. provide written informed consent for participation and complete baseline assessment\n\nExclusion criteria:\n\nAs the targeted population in this trial is primary care patients with subsyndromal mental ill-health that do not have a manifest specific common mental disorder, patients will be excluded if they meet diagnostic criteria for an anxiety disorder (social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia), a health anxiety disorder (hypochondriasis or illness anxiety disorder), obsessive-compulsive disorder, depression (depression or dysthymia), or a stress-related disorder (exhaustion disorder, adjustment disorder, or post-traumatic stress disorder). Note that meeting diagnostic criteria for not otherwise specified disorders (e.g., anxiety not otherwise specified), mixed anxiety and depressive disorder, or disorders subsumed under \"other\" categories is not a reason for exclusion.",{"count":129,"type":22},[57],"The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of subsyndromal mental ill-health in adult primary care patients. The main aim is to investigate:\n\nif online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with mental ill-health.\n\nResearchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced.\n\nParticipants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform.\n\nParticipants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.",[205],"Mental Ill-health",[207,208,209,210],"Primary Care","Transdiagnostic CBT","Online treatment","Subsyndromal mental ill-health",{"date":62,"type":34},{"date":213,"type":34},"2025-02-25",{"date":215,"type":22},"2029-02-06",{"name":40,"class":41},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":55,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":42},"100577949","transdiagnostic-online-cbt-vs-care-as-usual-for-primary-care-patients-with-common-mental-disorders-100577949","NCT06804941","Transdiagnostic Online CBT vs. Care as Usual for Primary Care Patients With Common Mental Disorders","Internet-based Transdiagnostic Cognitive Behavior Therapy and Care as Usual for Primary Care Patients With Mental Ill-health (RCT-1:Common Mental Disorders)","PRIMARITA-1","Inclusion Criteria:\n\nTo be included patients have to:\n\n1. have a common mental disorder in form of an anxiety disorder (social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia), health anxiety (hypochondriasis or illness anxiety disorder), obsessive-compulsive disorder, depression (depression or dysthymia), or a stress-related disorder (exhaustion disorder, adjustment disorder, or post-traumatic stress disorder), that warrants treatment,\n2. be at least 18 years old,\n3. have regular access to a device with an Internet connection,\n4. be able to read and write in Swedish,\n5. have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa,\n6. if on medication with monoamine agonist, have stable dosage in the past month,\n7. have no on-going psychological treatment, and\n8. provide written informed consent for participation and complete baseline assessment",{"count":129,"type":22},[57],"The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of common mental disorders in adult primary care patients. The main aim is to investigate:\n\nif online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with a common mental disorder.\n\nResearchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced.\n\nParticipants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform.\n\nParticipants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.",[229],"Common Mental Disorders (CMD)",[231,232,233],"Primary care","Transdiagnostic cognitive behavior therapy","online treatment",{"date":62,"type":34},{"date":236,"type":34},"2025-03-03",{"date":238,"type":22},"2029-01-25",{"name":40,"class":41},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":248,"minAge":106,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":55,"phases":251,"briefSummary":252,"conditions":253,"keywords":260,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"100608263","the-preeclampsia-postpartum-prevention-trial-100608263","NCT07199283","The PreEclampsia Postpartum Prevention Trial","The PEPP Trial: A Postpartum Bundle Intervention to Improve Cardiometabolic Health in Women After a First Pregnancy Affected by Preeclampsia - a Multi-centre Randomised Controlled Trial","PEPP","Inclusion Criteria\n\n* First-time mothers postpartum\n* Preeclampsia during first pregnancy\n* Age ≥ 18 years\n* Singleton live birth (infant still alive)\n* Ability to understand and speak Swedish, English\n* Having a smartphone (Android or iOS)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pre-pregnancy hypertension\n* Diabetes mellitus type I or II\n* Cardiovascular disease\n* Kidney disease\n* Systemic lupus erythematosus\n* Antiphospholipid syndrome\n* Previous or current eating disorders\n* Ongoing new pregnancy","FEMALE",{"count":250,"type":22},356,[57],"The goal of this clinical trial is to learn if a postpartum bundle intervention can improve cardiometabolic health and lifestyle-related factors in women who have had preeclampsia during their first pregnancy. The main questions it aims to answer are:\n\n* Does the 9-month intervention reduce systolic and diastolic blood pressure?\n* Does the intervention promote postpartum weight loss?\n* Does the intervention affect weight and blood pressure depending on early pregnancy BMI? Researchers will compare the bundle intervention to standard care to see if the intervention improves cardiometabolic health and lifestyle outcomes.\n\nAll participants will attend clinical visits for outcome assessments.\n\nParticipants in the intervention group will:\n\n* Receive online targeted screening and group meetings with study personnel\n* Use the trial-specific PEPP app to access self-monitoring tools for blood pressure and weight, lifestyle modification, and health education\n* Follow the intervention in two phases: starting after inclusion (≈8 weeks postpartum) with a Light phase (baseline-3 months) and progressing to an Intensive phase (3-9 months)",[254,255,256,257,258,259],"Preeclampsia","Postpartum Period","Hypertension","Cardiovascular Diseases","Overweight","Obesity",[254,261,262,256,263],"Postpartum prevention","Prevention cardiometabolic disease","Postpartum weight loss","2026-08-11",{"date":266,"type":34},"2026-08-12",{"date":268,"type":34},"2026-04-20",{"date":270,"type":22},"2028-04",{"name":40,"class":41},2,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":18,"sex":248,"minAge":106,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":55,"phases":282,"briefSummary":283,"conditions":284,"keywords":289,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":42},"100492831","the-impact-of-the-menstrual-cycle-on-physical-exercise-and-performance-100492831","NCT05697263","The Impact of the Menstrual Cycle on Physical Exercise and Performance","Inclusion Criteria:\n\n* Women exercising at least 3-4 times a week on a high level\n* Regular menstrual cycle with 26-32 cycle days.\n* Fully healthy and be able to follow the training program.\n\nExclusion Criteria:\n\n* Hormonal contraceptive users,\n* Users of regular medication\n* Chronic disease\n* Past or present neurological disorder\n* Recent musculoskeletal injury","35 Years",{"count":281,"type":22},111,[57],"The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups.\n\nThe purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise.\n\nFemale athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks):\n\nGroup A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase.\n\nGroup C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase.\n\nThe exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.",[285,286,287,288],"Menstrual Cycle","Exercise","Women's Health","Athletic Performance",[285,286,287,288],{"date":157,"type":34},{"date":292,"type":34},"2023-08-01",{"date":294,"type":22},"2027-07",{"name":40,"class":41},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":55,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":42},"100651397","preserving-muscle-mass-during-incretin-induced-weight-loss-100651397","NCT07761923","Preserving Muscle Mass During Incretin-Induced Weight Loss","Resistance Exercise Training to Preserve Muscle Mass and Physical Function During Incretin-Based Weight Loss","INCRETraIN","Inclusion Criteria:\n\n* Adults aged 18-64 years with obesity.\n* Planned initiation of incretin-based obesity pharmacotherapy as part of routine clinical care.\n* Able to participate in supervised unilateral resistance training.\n* Able to complete physical function tests.\n* Able to attend study visits at the study center.\n* Able to provide written informed consent in the Swedish language.\n\nExclusion Criteria:\n\n* Contraindication to magnetic resonance imaging.\n* Medical condition preventing resistance training or physical function testing.\n* Medical condition preventing skeletal muscle or adipose tissue biopsy.\n* Inability to understand study information in Swedish or provide informed consent.","64 Years",{"count":306,"type":22},20,[57],"Treatment with appetite suppressant drugs, including incretin-based receptor agonists, generally leads to clinically meaningful weight loss and reduced cardiometabolic risk. However, weight loss may include not only loss of adipose tissue but also loss of skeletal muscle mass, which ultimately may impair physical function and metabolic health.\n\nResistance training is an effective strategy to maintain or increase skeletal muscle mass during weight loss, but its effects during treatment with appetite suppressant obesity medications have been studied insufficiently. This study will investigate whether unilateral resistance training during incretin-based receptor agonist treatment can preserve or improve skeletal muscle mass. Additionally, the study will determine whether preservation of muscle is accompanied by the preservation of muscle function and\u002For molecular adaptations in skeletal muscle, adipose tissue and blood.\n\nParticipants will be adults with obesity who are about to start treatment with an incretin-based receptor agonist as part of routine clinical care. During the 13-week intervention, participants will perform supervised unilateral resistance training two times per week, training one leg while the other leg serves as an internal control. Data and tissue collection will take place before treatment start and after 13 weeks. Assessments include whole-body magnetic resonance imaging, blood sampling, skeletal muscle and adipose tissue biopsies, physical function tests, questionnaires, and monitoring of physical activity.",[310],"Obesity (BMI > 35)",[259,312,313,314,315],"Incretins","Skeletal muscle","Resistance training","Exercise training","2026-08-10",{"date":266,"type":34},{"date":319,"type":22},"2026-09-01",{"date":321,"type":22},"2029-01-01",{"name":40,"class":41},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":18,"sex":248,"minAge":106,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":55,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":343,"leadSponsor":345,"locationsCount":192},"100651192","endoexpedition---use-of-a-serious-game-to-deliver-patient-information-and-decision-aid-for-individuals-with-endometriosis-100651192","NCT07758946","Endoexpedition - Use of a Serious Game to Deliver Patient Information and Decision Aid for Individuals With Endometriosis.","Endoexpedition - Use of a Serious Game to Deliver Patient Information and Decision Aid for Individuals With Endometriosis: A National Multicenter Randomized-controlled Trial.","Inclusion Criteria:\n\n* Age 18 years or older.\n* Suspected or confirmed endometriosis.\n* Able to understand written Swedish.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Inability to independently complete the Swedish-language educational game.\n* Unwillingness or inability to provide informed consent.",{"count":331,"type":22},250,[57],"Endometriosis is a chronic disease that can negatively affect quality of life, daily functioning, fertility, and psychological well-being. Adequate patient education is important for informed decision-making and active participation in care, but traditional written information may not meet the needs of all patients.\n\nThis national multicenter randomized controlled trial will evaluate whether a serious game can improve patient satisfaction when delivering information about endometriosis and its treatment options compared with standard written information. Adults with suspected or confirmed endometriosis will be randomized to receive either game-based educational material (Endoexpedition) or traditional written information. The study will assess patient satisfaction, knowledge acquisition, engagement, knowledge retention, and user interaction with the educational platform. A total of 250 participants will be included and followed for up to one year.",[335],"Endometriosis",[335,337,338,339,340],"Serious game","Patient information","Digital Education","Decision Support",{"date":264,"type":34},{"date":319,"type":22},{"date":344,"type":22},"2029-09",{"name":40,"class":41},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":248,"minAge":106,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":55,"phases":356,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":192},"100631602","phase-3-the-power-trial-personalised-dose-optimisation-with-adjuvant-tamoxifen-therapy-in-breast-cancer-100631602","NCT07502820","The POWER Trial: Personalised Dose Optimisation With Adjuvant Tamoxifen Therapy in Breast cancER","The POWER Trial: A Randomised, Two-armed Open Label Phase 3 Clinical Trial on Personalised Dose Optimisation With Adjuvant Tamoxifen Therapy After Breast Cancer to Investigate the Impact on Discontinuation and Efficacy Compared to Standard of Care","POWER","Inclusion Criteria:\n\n* Patients with primary breast cancer, recommended for adjuvant tamoxifen treatment with or without concomitant goserelin\n* Premenopausal or perimenopausal, defined according to SOC for therapy decision\n* Eastern Cooperative Oncology Group (ECOG) WHO Performance Scale 0 - 2\n* Participants must use non-hormonal contraception during the trial.\n\nExclusion Criteria:\n\n* Previous use of tamoxifen, endoxifen, or aromatase inhibitors.\n* Previous medical history of:\n\nDeep venous thrombosis or pulmonary embolism; bleeding disorder or coagulopathy; macular disorders, retinal disorders, severe cataract or glaucoma.\n\n* Current use of warfarin.\n* Not willing to abstain from strong and moderate CYP2D6 inhibitors or CYP3A4 inducers during the tamoxifen treatment\n* Current pregnancy, breastfeeding, or already at start of tamoxifen planning to become pregnant within the next two years\n* Use of systemic menopausal hormonal therapy (MHT).\n* Prior invasive malignancy during the last five years. Prior or current in situ cancers are allowed.",{"count":355,"type":22},1100,[357],"PHASE3","In Sweden, approximately 7000 women are diagnosed with hormone-sensitive breast cancer annually. According to international and national guidelines, most of these women are recommended anti-hormonal therapy for five to ten years to improve prognosis. Tamoxifen, one of the most widely used anti-hormonal agents globally, reduces the risk of recurrence by 40% and breast cancer mortality by 30%.\n\nTamoxifen is a pro-drug that undergoes hepatic metabolism to form endoxifen and other active metabolites. Variability in metabolic capacity affects therapeutic efficacy: poor metabolisers produce insufficient endoxifen and other active metabolites, risking therapeutic failure, while ultrarapid metabolisers generate excessive amounts, leading to intolerable adverse effects. Today, 30-50% of patients discontinue treatment prematurely due to severe side effects, resulting in suboptimal outcomes.\n\nCurrently, tamoxifen is uniformly prescribed at a daily dose of 20 mg, and so far, no clinical trials have tested whether individualised dosing could enhance adherence and improve survival outcomes. The primary objective is to evaluate whether individualised tamoxifen dosing reduces discontinuation rates and enhances patient outcomes in breast cancer treatment.",[178,360],"Adjuvant Drug Therapy",[362,363,364,365,366,367],"Early-stage breast cancer","Adjuvant","Endocrine therapy","Tamoxifen","Therapeutic drug monitoring TDM","Precision medicine",{"date":266,"type":34},{"date":370,"type":34},"2026-04-14",{"date":372,"type":22},"2036-08",{"name":40,"class":41},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":42},"100582382","nordic-consortium-for-acute-type-a-aortic-dissection-2-100582382","NCT06862583","Nordic Consortium for Acute Type A Aortic Dissection-2","Nordic Multicenter Study of Risk Factors, Surgical Treatment and Outcomes in Acute Type A Aortic Dissection","NORCAAD-2","Inclusion Criteria:\n\n* Acute (within 14 days of onset) type A aortic dissection or similar acute aortic syndrome\n\nExclusion Criteria:\n\n* Age \\\u003C18 years at onset",{"count":21,"type":22},"The Nordic Consortium for Acute Type A Aortic Dissection-2 (NORCAAD-2) is a multicenter research collaboration involving up to 19 units in the Nordic countries and one in The Netherlands. All patients referred for this condition is included, to outline detailed preoperative characteristics and risk factors as well as, for those operated, data on the operative procedure, the postoperative course including major and minor complications and, as the primary interest, mortality in short- and long-term perspective. The need for further procedures on the aorta will also be studied.\n\nAcute type A Aortic Dissection (ATAAD) is a vascular emergency with very high case-fatality rate. The condition is realtively infrequent, and single units can rarely amass sufficient number of patients during a reasonable time to analyse also unusual variants in background, presentation, and management. Randomized controlled trials are unlikely, and large multicenter databases are the best source of knowledge for the foreseeable future. Other such databases exist, but NORCAAD-2 is more focused (only ATAAD) and more detailed than many counterparts, with the ability to extract unique information.\n\nNORCAAD-2 is the extension and expansion of the original NORCAAD project. NORCAAD-2 includes more centers, more patients, more data and utilizes a novel on-line common database designed for the purpose.\n\nThe ultimate goal is to identify novel risk markers to help inform decisions on pre-emptive surgery (before ATAAD occurs); to outline superior perioperative techniques and strategies to optimize outcomes both short- and long-term; and to analyze variables related to major complications, in an effort to further reduce their incidence.",[385],"Aortic Dissection",[387,388,389,390,391,392,393],"Open surgery","Risk factors","Outcomes","Mortality","Circulatory arrest","cerebral protection","bicuspid aortic valve",{"date":266,"type":34},{"date":396,"type":34},"2019-06-03",{"date":398,"type":22},"2030-06",{"name":40,"class":41},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":407,"targetDuration":409,"studyType":23,"phases":4,"briefSummary":410,"conditions":411,"keywords":421,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":42},"100568904","cognitive-impact-associated-with-surgery-for-gastric-or-esophageal-cancer-100568904","NCT06687291","Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer","CASE","Inclusion Criteria:\n\n* Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.\n* Age ≥18 at the time for inclusion.\n* Participate on a voluntary basis and can (for any reason) end its participation during the study.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n* Patients with preoperative cognitive dysfunction such as dementia.\n* Patients who are inoperable due to metastases.\n* Patients unable to communicate due to severely impaired hearing and\u002For - seeing.\n* Patients with ongoing drug and\u002For alcohol abuse.\n* Patients who cannot give informed consent.",{"count":408,"type":22},130,"6 Months","The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia.\n\nParticipants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium.\n\nThe main objective aims to answer:\n\nWhat is the incidence of POD after gastroesophageal cancer surgery.",[412,413,414,415,416,417,418,419,420],"Gastroesophageal Cancer (GC)","Postoperative Delirium (POD)","Quality of Life (QOL)","Frailty","Malnutrition","Sarcopenia","Chemobrain","Chemotherapy","Depression",[422,423,415,424,425,416,417,418,419],"postoperative delirium","gastroesophageal cancer","Quality of life","Preoperative depression",{"date":264,"type":34},{"date":428,"type":34},"2025-02-13",{"date":430,"type":22},"2028-11-11",{"name":40,"class":41},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":441,"conditions":442,"keywords":446,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":42},"100637996","perioperative-predictive-value-of-physical-activity-on-short--and-long-term-morbidity-and-mortality-100637996","NCT07603622","Perioperative Predictive Value of Physical Activity on Short- and Long-term Morbidity and Mortality","PeriopPrePA","Inclusion Criteria:\n\n* Elective non-cardiac surgery patients (equal to or over 18 years) at the two study sites, Karolinska University Hospital Solna and Karolinska University Hospital Huddinge\n\nExclusion Criteria:\n\n* Patients under the age of 18, transplant, day surgery, acute surgery, anesthesia monitoring, brachy therapy and gamma knife interventions. In case of multiple surgeries, only the first will be included.",{"count":440,"type":22},50000,"Over 300 million surgeries are performed globally every year. Complications after surgery - infections, cardiovascular conditions, postoperative pulmonary complications and renal impairment - affect survival and quality of life.\n\nAge and co-morbidity are unmodifiable factors, contributing to increased risk of these perioperative complications. However, a modifiable risk factor is physical activity. This study aims to test if self reported physical activity has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.",[443,444,445],"Anesthesia","Surgery","Surgery Complications",[447,448,390,449],"Perioperative medicine","Outcome","Morbidity","2026-08-09",{"date":266,"type":34},{"date":453,"type":34},"2026-05-01",{"date":455,"type":22},"2026-11-30",{"name":40,"class":41},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":18,"sex":248,"minAge":106,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":55,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":42},"100466064","spark--a-digital-platform-to-improve-self-management-of-gestational-diabetes-100466064","NCT05348863","SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes","SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control","SPARK","Inclusion Criteria:\n\n* a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines\n\nExclusion Criteria:\n\n* known pre-pregnancy diabetes\n* twin pregnancy\n* \\\u003C18 years of age\n* severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.","50 Years",{"count":467,"type":22},360,[57],"Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.",[471],"Gestational Diabetes Mellitus","2026-08-06",{"date":316,"type":34},{"date":475,"type":34},"2022-10-28",{"date":142,"type":22},{"name":40,"class":41},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":19,"minAge":484,"maxAge":79,"enrollmentInfo":485,"targetDuration":4,"studyType":55,"phases":487,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":42},"100650969","psychological-treatment-for-adolescents-with-self-injury-within-intensive-mental-health-outpatient-services-randomized-controlled-pilot-trial-100650969","NCT07755774","Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n* 12-17 years old\n* At least one NSSI episode in the past three months\n* A parent willing to engage in the parent program\n* Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)\n\nExclusion Criteria:\n\n* Immediate suicide risk\n* Social problems needing immediate intervention (e.g., violence within the family)\n* Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)\n* Ongoing dialectical behavior therapy for adolescents","12 Years",{"count":486,"type":22},40,[57],"The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.",[490,491,85],"Nonsuicidal Self Injury","Nonsuicidal Self-Injury",[493,494,495,496],"Nonsuicidal self-injury","Self-harm","Psychological treatment","Adolescence","2026-08-05",{"date":316,"type":34},{"date":500,"type":22},"2026-09",{"date":502,"type":22},"2028-06",{"name":40,"class":41},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":55,"phases":513,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":532},"100642922","recovery-after-cancer-application-100642922","NCT07642492","REcovery After Cancer Application","REcovery After Cancer Application (RECapp) - Personalised Support After Surgery for Oesophageal and Gastric Cancer Patients","RECapp","Inclusion Criteria\n\n* Patients who have undergone invasive surgery with curative intent for oesophageal or gastric cancer (including salvage surgery)\n* ≥18 years of age\n* Ability to read, understand, and complete study materials in Swedish, including consent forms, questionnaires, and instructions\n* Access to a smartphone or tablet with personal BankID\n\nExclusion Criteria\n\n\\- Cognitive impairment",{"count":331,"type":22},[57],"The RECapp study is a clinical trial evaluating a digital tool designed to support patients recovering from surgery for oesophageal or stomach cancer. The goal is to reduce symptoms and improve quality of life during recovery.\n\nEach year in Sweden, around 1,400 people are diagnosed with these cancers. Although more people are surviving thanks to better treatments, recovery after surgery is often long and challenging, with lasting physical and emotional effects. At the same time, healthcare systems are under pressure to provide long-term support.\n\nRECapp is a digital platform developed together with patients and healthcare professionals. It includes a mobile app for patients and a web portal for healthcare staff. Patients can track their symptoms, receive personalised self-care advice, and get guidance on when to contact healthcare. Healthcare providers can follow patients' progress remotely.\n\nIn this study, 250 patients from across Sweden will take part. They will be randomly assigned to either standard care or standard care plus RECapp. Participants will be followed for six months after surgery, and their symptoms and quality of life will be regularly assessed through questionnaires.\n\nIf RECapp proves effective, it could become part of future cancer care in Sweden-helping patients feel better supported while also making care more efficient.",[516,517],"Oesophageal Cancer","Gastric Cancer (Diagnosis)",[519,520,521,522,523,524],"Oesophageal cancer","Gastric cancer","Post surgery","Digital intervention","Symptom monitoring","Self-care advice","2026-08-04",{"date":497,"type":34},{"date":528,"type":22},"2026-09-15",{"date":530,"type":22},"2029-12-15",{"name":40,"class":41},7,{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":55,"phases":542,"briefSummary":543,"conditions":544,"keywords":547,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":42},"100640443","evaluation-of-restory---an-online-trauma-treatment-for-victims-of-sexual-abuse-100640443","NCT07610187","Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse","A Randomised Waitlist Controlled Clinical Trial of the Restory Trauma Treatment Program","Inclusion Criteria:\n\n* 18+ years\n* exposure to sexual violence where a minimum of 1 month has passed since the incident\n* self-reported total PCL-5 of minimum 30\n* current stable dose of psychotropic medication (for at least 4 weeks) or medication free\n* sufficient Swedish skills\n* willingness and availability to participate\n\nExclusion Criteria:\n\n* Ongoing trauma-related threat (e.g. living with a violent spouse)\n* severe psychiatric illness requiring immediate alternative treatment (such as high acute suicide risk or presence of psychotic episode, assessed during screening interview)\n* current participation in other trauma-focused CBT or Eye Movement Desensitization and Reprocessing therapy\n* current benzodiazepine treatment\n* no trauma memory",{"count":541,"type":22},140,[57],"This project aims to evaluate Restory - a newly developed anonymous, iCBT prolonged exposure therapy program specifically tailored for victims of sexual abuse - using a pre-registered randomized controlled trial with waitlist control. The primary research question is whether Restory is more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5.",[545,546],"PTSD - Post Traumatic Stress Disorder","Sexual Abuse",[548,549,546,550,551],"PTSD treatment","Anonymous","Trauma","Online",{"date":553,"type":34},"2026-08-07",{"date":555,"type":34},"2026-05-04",{"date":557,"type":22},"2027-11-04",{"name":40,"class":41},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":55,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":42},"100639736","evaluating-effects-of-group-based-cbt-for-emotion-regulation-in-adult-adhd-100639736","NCT07614867","Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD","Group-based Emotion Regulation Skills Training for Adults With ADHD: GEARS, a Quantitative and Qualitative Investigation of Treatment Effects","GEARS","Inclusion Criteria:\n\n* being diagnosed with ADHD according to DSM criteria,\n* age 18 years or above, and\n* having identified problems with emotion regulation difficulties.\n\nExclusion Criteria:\n\n* diagnosis of intellectual disability,\n* diagnosis of autism\n* substance abuse,\n* severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority,\n* difficulties allocating time to participate due to social, academic or occupational circumstances hindering engagement in treatment,\n* other ongoing psychotherapy, and\n* difficulties accepting the group setting.",{"count":568,"type":22},150,[57],"This study will evaluate if a specific treatment for emotion regulation in ADHD, GEARS, effectively reduces symptoms of emotional dysregulation. GEARS will be evaluated through a randomized controlled trial (RCT) and a qualitative interview study.\n\nThis project aims to investigate two main questions:\n\n1. Is GEARS an effective treatment for emotion regulation difficulties in adult ADHD patients?\n2. How do participants perceive the impact of completing the GEARS treatment? Study 1 investigates research question 1 through an RCT comparing GEARS to a passive control group. Data are collected using validated measures before and after treatment\u002Fwaiting period, as well as at six and 12 months follow ups.\n\nSample size: 150 participants, ensuring sufficient statistical power to detect significant between-group differences, even with some attrition.\n\nStudy 2 examines the patients' perspectives on the treatment by interviewing 15-20 participants about their experience with GEARS. The interviews focus on GEARS' perceived impact. Interviews will be recorded, transcribed, and analyzed using thematic analysis to identify key recurring themes.",[572],"Attention Deficit Disorder With or Without Hyperactivity (ADHD)",[574,575,576],"ADHD","Group Therapy","Cognitive Behavior Therapy",{"date":497,"type":34},{"date":579,"type":34},"2026-08-01",{"date":581,"type":22},"2029-06",{"name":40,"class":41},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":55,"phases":592,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":608},"100604139","app-based-medical-device-for-education-and-training-of-inhalation-technique-100604139","NCT07145632","APP-based Medical Device for Education and Training of Inhalation Technique","APPETITE","Inclusion Criteria:\n\n* Subjects at age \\>16 years\n* Willing to voluntarily participate in the study and give electronic written informed consent\n* Prescribed with daily inhalation therapy through DPI and\u002For MDI for doctor's diagnosed asthma or COPD.\n\nExclusion Criteria:\n\n* Age \\\u003C16 years,\n* No access to smartphone of type Android or iPhone\n* No access to electronic signature for informed consent\n* Plan to withdraw inhaler treatment including daily DPI and\u002For MDI the following 6-12 weeks.\n* Medical condition affecting the ability to independently inhale or use DPI or MDI device(s).",{"count":591,"type":22},80,[57],"Primary aim: To investigate if app-based education and training of inhalation technique improves the rate of successful inhalation techniques compared with control group at 6-12 weeks follow-up visit.\n\nSecondary aims: To evaluate the feasibility, usability, and safety of the investigational during the study period.\n\nStudy design: Two-armed, parallel-designed, individual single-blinded stratified randomisation by inhaler (DPI\u002FMDI\u002Fboth DPI and MDI) controlled trial with assignment (1:1) to (1) standard care and app-based education and training of inhalation technique or (2) standard education of inhalation technique over 6-12 weeks.\n\nSubjects: Subjects from the age of 16 years with documented diagnosis of asthma and\u002For COPD, daily treated with dry powder inhaler (DPI) or metered dose inhaler (MDI), or both, will be invited to voluntarily participate. Exclusion criteria is age \\\u003C16 years, no access to use BankID or similar electronic personal identification service, not using smartphone of type Android or iPhone, plan to stop use DPI and\u002For MDI the following 6-12 weeks from inclusion. No able to independently handle and inhale through DPI or MDI device.\n\nTotal sample size: Eighty subjects (females and males) with daily treatment for COPD or asthma will be sufficient, based on the assumption of 25% percentage improvement in success rate of correct inhalation technique in the interventional group compared with control group (75% versus 50%) with 80% power at 5% significance level, including dropouts at 6-12 weeks follow-up visit.\n\nIntervention: At the baseline visit patients will be randomised to app-based intervention consisting of education and training of inhalation technique of all inhalers used on daily basis (the inhalation app-module). Stratified randomisation based on type of inhaler(s); MDI, DPI or both MDI and DPI will be applied. The intervention is the inhalation app-module, which is a medical device that is embedded the AsthmaTuner app. The AsthmaTuner app is a CE-marked cloud-based system (MDR Class 2b), provided by MediTuner AB, Stockholm, Sweden. The intervention group will be instructed to use the inhalation app-module on daily basis to improve their inhalation technique.\n\nControl group: Standard education of inhalation technique using list of standardised criteria and non-app-based education of inhaler technique.\n\nEndpoints: Primary endpoint is the rate of subjects with successful inhalation techniques based on subjective critical endpoints (CIP Table 2) and the following objective endpoints at the 6-12 weeks follow up visit:\n\n* DPI: PIF \\> 30 L\u002FMin, time to PIF \\\u003C0.5 seconds measured with the investigational device.\n* MDI: inspiration time (\\> 3 seconds) and PIF less than 60 L\u002FMin measured with the investigational device.\n\nProcedures: At baseline, a trained respiratory nurse will subjectively assess and train each patient's inhalation technique according to defined criteria of device handling (standard education). The AsthmaTuner app is downloaded to a smartphone or tablet computer (Ipad) that is wirelessly (Bluetooth) connected to a home spirometer. In this study the Bluetooth spirometer AsthmaTuner from MIR will be used. Education and training of inhalation technique will include measurement of inhalation flow with an adjustable resistance mounted on the spirometer, Airflow Trainer (MIR). The app gives instruction to set the resistance, so it corresponds to the selected inhaler. Questionnaires and interviews will collect information about the feasibility, safety and experienced usability of the investigational device.\n\nAnalysis: The rate of subjects with successful inhalation technique at 6-12-week visit determined by fulfilling objective and subjective critical endpoints in intention-to-treat approach. The effect of using the inhalation app-module will be analysed with logistic regression analysis across randomisation groups. The secondary analysis of feasibility and the experienced benefit of using the inhalation app-module in clinical practice and for patient's education and training of inhalation technique is estimated on a Likert scale from 1 (not at all) to 5 (strongly agree) and presented as mean and median scores.",[595,596],"Asthma (Part 1)","COPD",[598,599,600,601],"Management","Inhaler technique","Metered Dose Inhaler - MDI","Dry Powder Inhaler - DPI",{"date":553,"type":34},{"date":604,"type":34},"2025-06-01",{"date":606,"type":22},"2027-06-01",{"name":40,"class":41},3,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":19,"minAge":106,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":55,"phases":618,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":42},"100593144","cholangiography-performed-routinely-versus-selectively-during-cholecystectomy-a-national-registry-based-randomized-controlled-trial-100593144","NCT07002619","ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial","COGNAC","Inclusion Criteria:\n\n* Patients undergoing cholecystectomy\n\nExclusion Criteria:\n\n* Preoperative suspicion of common bile duct stone\n* Pregnancy\n* Age \\\u003C18 years\n* Preoperative suspicion of malignancy in the gallbladder or bile ducts",{"count":617,"type":22},6000,[57],"Common bile duct stones (CBDS) may be asymptomatic but can cause pancreatitis, obstructive jaundice, and\u002For cholangitis. In Sweden, intraoperative cholangiography (IOC) is usually performed during gallstone surgery in order to detect CBDS and proactively extract them. The intervention to extract them may, however, cause complications by itself such as pancreatitis, bleeding, or perforation. In many countries, IOC is performed selectively when CBDS are suspected preoperatively (by patient history, imaging, or blood tests), or if the anatomy is unclear. There is a knowledge gap regarding the relation between risks associated with refraining from IOC and, thus, leaving undetected CBDS in situ, or actively diagnosing and removing the stones.\n\nTo compare these risks, we propose a national multicenter randomized controlled trial. The study will be embedded in the Swedish Registry for Gallstone Surgery (GallRiks), which will include all variables for inclusion and follow-up.\n\nPopulation: Patients undergoing gallstone surgery without suspicion of CBDS Intervention: IOC Control: No IOC Outcome: Readmission or reintervention (Clavien-Dindo grade ≥IIIa) related to the cholecystectomy within 12 months after the operation.\n\nA total of 6000 patients will be recruited. The results will have the potential to provide level A evidence for routines used in gallstone surgery not only in Sweden, but also internationally.",[621,622],"Cholecystolithiasis","Common Bile Duct Gall Stones",[624,625],"Cholecystectomy","Intraoperative cholangiography",{"date":553,"type":34},{"date":628,"type":34},"2023-05-01",{"date":630,"type":22},"2029-12",{"name":40,"class":41},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":18,"sex":19,"minAge":640,"maxAge":640,"enrollmentInfo":641,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":42},"100589676","analysis-of-salivary-proteins-in-young-children-as-an-device-to-improve-caries-risk-assessment-100589676","NCT06957509","Analysis of Salivary Proteins in Young Children as an Device to Improve Caries Risk Assessment","Salivary Metaproteome as a Prediction Tool in Early Childhood Caries","DecodECC","Inclusion Criteria:\n\n* 3-year-old children residing in the areas served by Folktandvården Danderyd and Järva, respectively\n* Written consent, signed by both parents (guardians)\n\nExclusion Criteria:\n\n* children older than three years\n* medication intake, and antibiotic use at the time of examination\n* children who have consumed food, drink, or used oral hygiene products within 2 hours before the dental visit\n* children who appear uncooperative during saliva sampling","3 Years",{"count":642,"type":22},100,"The goal of this observational study is to learn if the composition of salivary proteins in 3-year-old children, from communities with documented varying caries risks, can be used to identify future diagnostic predictors for caries risk.\n\nThe main question to answer is:\n\n• Can the host´s salivary protein profile (expression and abundance) show a correlation with the caries prevalence between the individuals in the different study cohorts?\n\nTwo cohorts of children with different documented demographic characteristics in the region of Stockholm (Sweden) will be examined.\n\nParticipants will be asked to provide saliva samples and undergo clinical oral examinations conducted by trained dental practitioners.",[645],"Early Childhood Caries (ECC)",[647,648,649,650],"early childhood caries","saliva","metaproteins","caries risk assessment",{"date":497,"type":34},{"date":653,"type":34},"2025-04-04",{"date":655,"type":22},"2027-12",{"name":40,"class":41},""]