[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital, Akershus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":572},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,45,79,103,130,159,186,221,251,275,295,325,353,385,414,442,468,501,528,549],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100560408","management-of-patients-with-heart-failure-at-home-after-hospital-discharge-100560408",false,"NCT06576752","Management of Patients With Heart Failure at Home After Hospital Discharge","Contemporary Post-Discharge Management in Heart Failure at Home","STRONG@HOME","Inclusion Criteria:\n\n* Hospital admission within the 72 hours prior to screening for acute HF.\n* NT-proBNP ≥ 1,000 pg\u002FmL measured during the hospitalization\n* Systolic blood pressure ≥ 100 mmHg and of heart rate ≥ 60 bpm within 24 hours before randomization\n* Serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n* ≤ ½ the optimal dose of ACEi\u002FARB\u002FARNi or beta-blocker or MRA.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Age below 18 or above 85 years.\n2. Clearly documented intolerance to high doses of beta-blockers\n3. Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).\n4. Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL\u002Fmin\u002F1.73m2 at screening or history of dialysis.\n5. Prior (defined as less than 30 days from screening) or current enrollment in a HF intervention or participation in an investigational drug or device study within the 30 days prior to screening\n6. Index event (admission for acute HF) triggered primarily by a completely reversable etiology so that it is unlikely the patient will be classified with chronic HF after discharge, such as Takotsubo syndrome (stress cardiomyopathy). In the setting of acute coronary syndrome or tachycardia, this should be managed before considering the presence of HF. This does not apply to patients with chronic HF prior to the index event.\n7. Severe non-adherence to medications\n8. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months.\n9. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.\n10. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n11. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patients ability to understand and\u002For comply with the protocol instructions or follow-up procedures.\n12. Low digital competency classified as inability to handle a smartphone or tablet.\n13. Language barriers requiring the need for an external interpreter.\n14. Pregnant or nursing (lactating) women.","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to assess whether patients with acute heart failure (HF) can achieve the same level of HF-therapies by digital follow-up at home as compared to hospital visits according to the STRONG-HF strategy. Patients admitted to hospital with acute HF will be enrolled and randomized to either follow-up at the hospital out-patient clinic or digital follow-up at home.",[27],"Heart Failure",[29,30,31],"heart failure","digital health","remote monitoring","RECRUITING","2026-06-16",{"date":35,"type":36},"2026-06-17","ACTUAL",{"date":38,"type":36},"2024-10-01",{"date":40,"type":21},"2029-12-31",{"name":42,"class":43},"University Hospital, Akershus","OTHER",11,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100637234","mental-health-intervention-with-digital-applications-mind-app-randomized-controlled-researcher-blinded-trial-evaluating-the-effectiveness-of-the-tankevirus-and-grubl-mental-health-apps-100637234","NCT07627204","Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps","App-Based Mental Health Interventions for Anxiety and Depression: Protocol for the MIND-APP Randomized Controlled Trial","MIND-APP","Inclusion Criteria:\n\n* Adults and adolescents aged 16 years or older (16 is the minimum age of consent without parental approval for participation in research in Norway. Inclusion of individuals aged younger than 18 years will be highlighted in the ethical review.)\n* Residing in Norway\n* Access to a compatible smartphone (iOS or Android)\n* Reporting mild to moderately severe symptoms of anxiety and\u002For depression (Patient Health Questionnaire-9 \\[PHQ-9\\] score ≥5 and\u002For Generalized Anxiety Disorder-7 \\[GAD-7\\] ≥5)\n* Able to read Norwegian and use Norwegian to a sufficient level\n* Able and willing to provide consent for the study prior to participation\n\nExclusion Criteria:\n\n* PHQ-9 score ≥20 (severe depression)\n* Active suicidal ideation (PHQ-9 item 9 score ≥2)\n* Have ever required hospitalization for mental illness or are currently taking antipsychotic or other psychotropic medications\n* Current engagement in psychological treatment\n* Report having used Tankevirus or Grubl apps in the past","16 Years",{"count":55,"type":21},1000,[24],"The MIND-APP trial is a 3-arm randomized controlled trial (1:1:1 allocation) conducted fully remotely via a bespoke smartphone research platform. A total of 1000 Norwegian residents aged 16 years or older with mild to moderate symptoms of anxiety and\u002For depression will be recruited through national digital outreach. Coprimary outcomes are changes in anxiety (Generalized Anxiety Disorder-7) and depression (Patient Health Questionnaire-9) scores from baseline to postintervention (2-4 weeks). Secondary outcomes include health-related quality of life (EQ-5D-5L), quality-adjusted life years accrued over 6 months, functional impairment (Work and Social Adjustment Scale), health care resource use, and adverse events. Incremental cost-effectiveness ratios for Tankevirus and Grubl relative to placebo will be estimated from the perspective of public health services.",[59,60],"Anxiety","Depression",[59,60,62,63,64,30,65,66,67,68],"Cognitive Behavioral Therapy","CBT","cost-effectiveness","metacognitive therapy","Norway","QALY","Application","NOT_YET_RECRUITING","2026-06-01",{"date":72,"type":36},"2026-06-04",{"date":74,"type":21},"2027-08-15",{"date":76,"type":21},"2028-03-31",{"name":42,"class":43},1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":53,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":78},"100623301","mechanisms-of-persistent-fatigue-100623301","NCT07394855","Mechanisms of Persistent Fatigue","Mechanisms of Persistent Fatigue (MAP-FAT): A Prospective Observational Cohort Study of Persistent Fatigue Following Epstein-Barr Virus Infection in Adolescents and Young Adults","MAP-FAT","Inclusion Criteria (pertaining to EBV group only):\n\n* EBV infection, laboratory confirmed.\n* First symptoms \\> 3 and \\\u003C 6 weeks away\n\nExclusion Criteria (pertaining to both groups)\n\n* Co-morbidity, including mental illness (seasonal allergy\u002Fasthma is accepted if no signs\u002Fsymptoms)\n* Usage of pharmaceuticals (hormonal contraception and paracetamol\u002Fibuprofen is accepted)\n* Concurrent demanding life event causing fatigue.\n* Disability impacting on daily living.\n* Regular smoking\n* Usage of illicit drugs\n* Pregnancy",true,"39 Years",{"count":90,"type":21},300,"OBSERVATIONAL","Persistent fatigue (PF) is a common symptom across countries and cultures, and an important cause of disability and reduced quality of life. Acute infection is a common trigger of PF, as exemplified by the 'Long COVID' phenomenon. Despite substantial burden for the suffering individuals as well as their next-of-kins, the healthcare systems and the economy, PF is an under-researched field, with scarce knowledge of disease mechanisms as well as treatment and preventive measures.\n\nExisting knowledge on PF suggests complex interactions between functional brain processes (as opposed to permanent brain damage), aberrations of the immune system (that normally protects against infection) and the autonomic (or non-voluntary) part of the nervous system (that monitors the internal state of the body and adjusts the function of internal organs). Previous findings have been interpreted in light of two alternative models: A body-to-brain mechanism where disturbances of the immune system are thought to impact on brain functions, and a brain-to-body mechanism where functional brain alteration is regarded the central element whereas aberration of the immune system is seen as a consequence (rather than a cause) mediated through altered activity of the autonomic nervous system.\n\nThe multinational and collaborative Mechanism of Persistent Fatigue (MAP-FAT) project is determined to scrutinize both these potential brain-body interactions in PF. The main objectives are: a) To determine the relationship between PF, activities in certain brain areas, activity in a certain part of the autonomic nervous system (the sympathetic branch), and immunological alterations; b) To determine whether PF is primarily dependent upon the brain's automatic predictions rather than the continuous sensory information mediated to the brain. To achieve these objectives, MAP-FAT will exploit an existing health registry on post-infective fatigue (preparatory part) and conduct a new post-infective cohort study (main part) in which a total of 150 individuals with \"kissing disease\" and 150 healthy controls are followed for six months. Investigations include: a) Clinical and demographic assessment; b) Questionnaire charting; c) Functional and structural imaging of the brain (multimodal brain MRI); d) Assessment of autonomic nervous system activity; e) Deep immunological profiling; and f) Behavioral experiments. The latter are specifically designed to disentangle the relative contributions of the brain's automatic predictions and sensory input for the experience of PF. In addition, one of the experiments includes concurrent functional brain imaging, autonomic nervous system assessment, and immunological profiling during experimental injections of drugs that impact on autonomic activity; this experiment is key for addressing the causal association between brain functions, autonomic activity and immunological disturbance.",[94],"Fatigue Post Viral","2026-05-19",{"date":97,"type":36},"2026-05-22",{"date":99,"type":36},"2026-04-28",{"date":101,"type":21},"2027-12",{"name":42,"class":43},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100571553","diabetes-related-foot-ulcers-with-negative-pressure-wound-therapy-100571553","NCT06721754","Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy","Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy: A Randomized Controlled Trial","DIANE","Inclusion Criteria:\n\n* Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation\n\nExclusion Criteria:\n\n* Previous leg amputation due to diabetes\n* Unable to ambulate on feet\n* Unlikely to adhere to treatment and\u002For follow-up\n* Unable to complete questionnaire\n* Active or ongoing cancer treatment\n* In need of amputation at a higher level than metatarsal or more than two metatarsals",{"count":112,"type":21},50,[24],"The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs).\n\nThe main questions it aims to answer are:\n\n* Will there be a difference in the number of major amputations between the groups during the first year?\n* Will one of the treatments require more surgeries and longer hospital stays?\n\nAll participants will:\n\n* be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery\n* be followed closely at the out-patient clinic for one year after treatment",[116],"Diabetic Foot Ulcer",[116,118,119,120,121],"Negative Pressure Wound Treatment","Randomized Controlled Trial","Standard Wound Treatment","Amputation",{"date":123,"type":36},"2026-05-04",{"date":125,"type":36},"2025-01-02",{"date":127,"type":21},"2028-12-31",{"name":42,"class":43},2,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":146,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":129},"100635908","vexus-assessment-and-natriuresis-guided-diuretic-therapy-in-acute-heart-failure-100635908","NCT07558798","Vexus Assessment and Natriuresis-guided Diuretic Therapy in Acute Heart Failure","VANTAGE-HF","Inclusion Criteria:\n\n* Age \\>18 years\n* Hospitalization with AHF, either de novo or worsening of chronic HF\n* Able to provide written informed consent\n* Requirement of intravenous loop diuretic treatment as judged by the treating physician\n\nExclusion Criteria:\n\n* Dyspnea primarily due to non-cardiac causes\n* Advanced renal disease or estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73m2 at screening or on-going dialysis.\n* Enrollment in another study interfering with the treatment algorithm of the current study\n* Inability to follow the treatment protocol\n* Language barriers requiring the need for an external interpreter\n* Pregnant or nursing (lactating) women\n* Very short life expectancy (\\\u003C30 days)",{"count":138,"type":21},270,[24],"This study evaluates whether natriuresis-guided diuretic therapy improves outcomes in patients with acute heart failure (AHF) and severe congestion. All patients hospitalized with AHF will be screened using Venous Excess Ultrasound (VExUS) and randomized 1:1 to either natriuresis-guided escalation of loop diuretics or standard care. The primary endpoint, evaluated in patients with VExUS grade 3 (severe congestion), is a hierarchical composite (win ratio) of 90-day mortality, 90-day rehospitalization, and hospital length of stay. Key secondary endpoints (hierarchical) include (1) difference in win ratio between patients with VExUS 3 versus VExUS 0-2 at hospital admission (assessed by interaction testing and statistically tested only if the primary endpoint is significant) and (2) win ratio (primary endpoint) tested among patients with VExUS 0-2 at hospital admission (statistically tested only if the first key seconday endpoint is significant). Exploratory endpoints include in-hospital clinical, hemodynamic, and biochemical outcomes (mortality, eGFR, NT-proBNP, NYHA class, VExUS score, natriuresis\u002Fdiuresis, and patient-reported dyspnea), associations between congestion markers (VExUS, FibroScan, lung ultrasound, clinical score, and NT-proBNP), as well as quality of life at 90 days, GDMT optimization score at discharge, and long-term time to readmission and mortality assessed through registry linkage.",[142,143,144,145],"Venous Congestion","Heart Failure Acute","VExUS","Diuretics",[147,29,148,149,150],"loop diuretics","acute heart failure","vexus","congestion","2026-04-23",{"date":153,"type":36},"2026-04-30",{"date":155,"type":21},"2026-04",{"date":157,"type":21},"2028-06",{"name":42,"class":43},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100570853","phase-4-aminoglycosides-in-early-sepsis-100570853","NCT06712641","Aminoglycosides in Early Sepsis","Aminoglycosides in Early Sepsis (AGES): A Randomized Pragmatic Clinical Trial Comparing Gentamicin and Narrow Spectrum Betalactams to Broad Spectrum Betalactams as Empirical Treatment in Patients With Suspected Sepsis","AGES","Inclusion Criteria:\n\n* Hospitalized\n* Adults 18 year or older\n* Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy\n* National Early Warning Score 2 (NEWS2) ≥ 5\n* Signed informed consent must be obtained and documented according to ICH GCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Established chronic kidney failure (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2)\n* Presentation with septic shock with multiorgan failure\n* Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection)\n* Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months)\n* Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or other drug-resistant microbes necessitating specific antimicrobial therapy\n* Multiple myeloma\n* Renal transplantation\n* Renal replacement therapy\n* Myasthenia gravis\n* Known hypersensitivity to any of the study drugs\n* Pregnancy",{"count":168,"type":21},1900,[170],"PHASE4","Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance.\n\nIn patients with suspected community acquired sepsis, the investigators hypothesize that empirical combination therapy with narrow spectrum betalactams and aminoglycosides is safe and non-inferior to empirical therapy with broad spectrum betalactams. More specifically, the investigators hypothesize that the proportion of patients with acute kidney injury or death will be similar between these two treatment groups. Furthermore, the investigators hypothesize that the aminoglycoside-based regimen has lesser impact on the gut microbiome. Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required but failed to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In this context, novel initiatives aiming at reducing use of antibiotics are direly needed.",[173],"Sepsis",[175,176,177,178],"sepsis","antibiotics","aminoglycosides","cephalosporins",{"date":180,"type":36},"2026-04-24",{"date":151,"type":36},{"date":183,"type":21},"2033-05",{"name":42,"class":43},5,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":204,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":78},"100616121","akershus-cardiac-examination-ace-5-study-100616121","NCT07301489","Akershus Cardiac Examination (ACE) 5 Study","Akershus Cardiac Examination (ACE) 5 Study: Pragmatic Randomized Controlled Trial of Lung Cancer Screening Plus Program to Improve Cardiovascular Risk Profile and Health in Individuals With Heavy Smoking History","ACE5","Inclusion Criteria used for the lung cancer screening implementation study\u002F TIDL Study:\n\n* Women and men\n* Ages 60 to 79 years old (inclusive)\n* A smoking history of at least 35 pack-years and 1) being a current smoker or a former smoker who quit less than 10 years prior or 2) having a PLCOm2012 model 6-year risk for lung cancer incidence over 2.6%.\n* Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures\n* Written informed consent obtained prior to performing any protocol-related procedures\n* The participant should be affiliated to a social security system\n\nExclusion Criteria used for the lung cancer screening implementation study\u002F TIDL Study:\n\n* Recent abnormal pulmonary findings under work-up of standard care\n* Having had chest CT \\\u003C1 year before potential entry into the study\n* Current or prior history of lung cancer, renal cancer, melanoma or breast cancer\n* Inability to provide signed informed consent\n* Insufficient understanding of the languages in which trial information is available\n* Psychiatric or other disorders that are incompatible with compliance to the protocol requirements and follow-up\n* Unable to be followed-up for at least 5-years\n* Body weight \\>140 Kg because of difficulty of conducting the CT exam\n\nInclusion Criteria used for the ACE 5 Study:\n\n* Participants from the TIDL Study with non-contrast, non-cardiac chest CT images available as part of the implementation lung cancer screening study\n* Signed consent for cardiovascular add on-study and agree to protocol, including follow-up visit 1-year after the baseline examination\n\nExclusion Criteria used for the ACE 5 Study:\n\n* Any surgical or medical condition, including short life-expectancy, based on medical records or clinical findings prior to randomization, that will impair the ability of the patient to participate in the study\n* Patients unwilling or unable to comply with the protocol\n* History of non-compliance to medical management and patients who are considered potentially unreliable, based on information obtained prior to randomization\n* History or evidence of alcohol or drug abuse with the last 12 months, based on information obtained prior to randomization, that will influence study participation","60 Years","79 Years",{"count":55,"type":21},[24],"Individuals with extensive smoking history have 2- to 3-fold increased risk of dying prematurely compared to age- and gender-matched peers. Historical data indicate that 55% of heavy smokers will die from cardiovascular disease (CVD), while approximately 5% will die from lung cancer. Lung cancer screening programs are currently being implemented worldwide, but efforts to reduce also CVD are not included.\n\nThe research group behind the ACE 5 Study are affiliated with the study team behind the implementation study of lung cancer screening in Norway (\"Tidlig oppdagelse av lungekreft \\[TIDL\\]\"). The TIDL Study have performed non-contrast, non-cardiac chest CT-based screening for lung cancer in 1000 individuals. Prior studies have demonstrated that a visual four-group classification of coronary artery calcification using non-contrast, non-cardiac chest CT images provide an easily available, non-invasive surrogate index for subclinical and established chronic coronary syndrome. Accordingly, the 2024 European Society of Cardiology guidelines for chronic coronary syndrome promotes that opportunistic screening for atherosclerotic CVD (ASCVD) should be performed when non-contrast, non-cardiac chest CT images are available (\"IIa recommendation\"). The investigators will now invite TIDL participants for a second study, the Akershus Cardiac Examination (ACE) 5 Study, which will assess whether intervention also against ASCVD (\"Lung Cancer Screening Plus Program\") will improve cardiovascular risk profile and cardiovascular health in individuals with heavy smoking history.\n\nThe ACE 5 Study will be a separate study with separate protocol and consent as the ACE 5 Study will focus on the prevention of CVD in individuals with heavy smoking history as add-on to lung cancer screening. The ACE 5 Study will assess the combined effect of (1) non-contrast, non-cardiac chest CT images as basis for ASCVD detection, and (2) the value of a hospital-based, nurse-led follow-up program to improve cardiovascular risk profile and cardiovascular health in individuals with heavy smoking history. Whether a Lung Cancer Screening Plus Program can improve cardiovascular risk profile and indices of improved cardiovascular health compared to the current strategy\u002Fstandard in individuals with heavy smoking history is currently not known. The primary endpoint relates to status for cardiovascular risk profile after 1-year follow-up, and the study will use pre-defined cutoffs for the different risk factors based on relevant European Society of Cardiology (ESC) Guidelines, especially the 2021 ESC guidelines for primary prevention and the 2024 ESC guidelines for chronic coronary syndrome.",[200,201,202,203],"Heavy Smokers","Lung Cancer Screening","Cardiovascular Risk Profile","Cardiovascular Disease Prevention",[205,206,207,208,209,210,211,212],"Heavy smokers","Lung cancer screening","Cardiovascular risk profile","Cardiovascular disease prevention","Chronic coronary syndrome","Atherosclerotic cardiovascular disease","Non-contrast, non-cardiac chest CT-based screening","Nurse-led follow-up program","2025-12-10",{"date":215,"type":36},"2025-12-24",{"date":217,"type":36},"2025-10-01",{"date":219,"type":21},"2041-04",{"name":42,"class":43},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":238,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100442763","phase-4-antibiotic-therapy-in-viral-airway-infections-100442763","NCT05045612","Antibiotic Therapy in Viral Airway Infections","Antibiotic Therapy in Viral Airway Infections: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Efficacy and Safety of Discontinuing Antibiotic Therapy in Adult Patients With Respiratory Viruses","ATHENIAN","Inclusion Criteria:\n\n* Hospitalized\n* Adults 18 year or older\n* Moderately severe disease (CRB65 ≤ 2 at time of inclusion)\n* Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)\n* On antibiotic therapy as instituted by the receiving physician from the emergency department\n* Signed informed consent must be obtained and documented according to ICH GCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Requiring ICU admission at screening\n* Requiring high-flow oxygen therapy or non-invasive ventilation at screening\n* Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)\n* Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression due to solid organ transplant)\n* SARS-CoV-2 positive\n* Bacteremia\n* Urine antigen test positive for legionella\n* Any other infection necessitating antibiotic treatment\n* Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital\n* Time from initiation of antibiotic therapy to screening \\>48 hours",{"count":230,"type":21},380,[170],"Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In the current proposal, the investigators aim to assess the efficacy and safety of early discontinuation of antibiotic therapy in adult patients infected with respiratory viruses.\n\nA general recommendation to treat all instances of community acquired pneumonia (CAP) patients with antibiotics leads to significant antibiotic overtreatment. In 2008, the US Food and Drug Administration approved the first multiplex polymerase chain reaction assay for the detection of multiple respiratory virus nucleic acids simultaneously. The wide availability of such nucleic acid amplification tests (NAAT) for rapid viral detection together with chest radiographs has the potential to define patients who can be managed without antibiotics.\n\nAkershus University Hospital is one of the largest hospitals in Norway, with a catchment area of more than 550,000 people. In 2012 to 2013, the majority of patients admitted to Akershus University Hospital with suspected CAP and a positive viral NAAT were treated with antibiotics, a prescription pattern representing antibiotic overtreatment. The investigators accordingly hypothesize that discontinuation of antibiotic therapy in patients with moderately severe disease and airway sample positive for respiratory viruses is safe and non-inferior to continuation of antibiotic therapy.",[234,235,236,237],"Infectious Disease","Influenza","Respiratory Syncytial Virus (RSV)","Respiratory Tract Infections",[239,240,241],"pragmatic trial","antibiotic stewardship","viral respiratory tract infection","2025-08-11",{"date":244,"type":36},"2025-08-12",{"date":246,"type":36},"2022-01-13",{"date":248,"type":21},"2029-11",{"name":42,"class":43},12,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":78},"100468339","the-akershus-study-of-ischemic-stroke-and-thrombolysis--1-100468339","NCT05378490","The Akershus Study of Ischemic Stroke and Thrombolysis -1","The Akershus Study of Ischemic Stroke and Thrombolysis -1 (ASIST-1) Epidemiology, Clinical and Radiological Presentation and Treatment of Cerebrovascular Disease and Stroke Mimics in a Norwegian Population","ASIST-1","Inclusion Criteria:\n\n* Cerebrovascular diseases (acute ischemic stroke, intracerebral hemorrhage, transient ischemic attack) or stroke mimics\n\nExclusion Criteria:\n\n* None",{"count":260,"type":21},6000,"This observational study comprises consecutively patients with cerebrovascular diseases admitted to the Stroke Unit at Akershus University Hospital in Norway. Akershus University Hospital is the largest emergency care hospital in Norway and has a catchment area covering a population of 550.000, which is approximately 10 % of the Norwegian population and reasonably representative according to data from Statistics Norway. The hospital is public and serving both as a primary hospital and a university hospital. Due to the Norwegian, national, all-covering health-insurance, all patients enter the hospital and are considered for further in-patient care on the same conditions. The hospital has a stroke unit classified as a comprehensive stroke center according to European Stroke Organisation standards. Acute stroke management follows national and international guidelines. Overall, the ASIST-1 study will investigate management, outcome and prognosis of stroke and stroke care pathways and later follow up in primary care using several approaches combining existing clinical data from a representative population with different Norwegian health registries. Parts of the study are retrospective with prospective follow-up by health registries and parts of the study are prospective.",[263,264,265,266],"Stroke, Acute","Intracerebral Hemorrhage","Stroke, Ischemic","TIA","2025-02-03",{"date":269,"type":36},"2025-02-05",{"date":271,"type":36},"2012-01-01",{"date":273,"type":21},"2040-12-31",{"name":42,"class":43},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":78},"100440891","the-norwegian-cerebral-venous-thrombosis-study-100440891","NCT05021198","The Norwegian Cerebral Venous Thrombosis Study","Epidemiology, Clinical and Radiological Presentation and Long-term Prognosis of Cerebral Venous Thrombosis in a Norwegian Population (NoCVT)","NoCVT","Inclusion Criteria:\n\n* A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals\n\nExclusion Criteria:\n\n* none",{"count":284,"type":21},600,"The NoCVT study will investigate CVT (2014-2023) in a large Norwegian population (\\> 3 millions) using several approaches combining existing health registries, clinical databases and new prospectively collected clinical data to explore epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of CVT.",[287,288],"Cerebral Vein Thrombosis","Cerebral Venous Sinus Thrombosis",{"date":269,"type":36},{"date":291,"type":36},"2014-01-01",{"date":293,"type":21},"2027-01",{"name":42,"class":43},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":129},"100421625","how-to-best-treat-anterior-cruciate-ligament-injuries-100421625","NCT04770233","How to Best Treat Anterior Cruciate Ligament Injuries","Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery","Inclusion Criteria:\n\n* Patients who have sustained an acute ACL injury (must be possible to perform the \"early surgery\" treatment option within 12 weeks)\n* Age 16-50 years and skeletally mature\n* No previous surgery in the index knee or knee injury which influences rehabilitation\n* Patient capable to undergo both surgery and rehabilitation\n\nExclusion Criteria:\n\n• Elite athletes (Tegner 10) in pivoting sports and patients with additional knee injuries warranting repair","50 Years",{"count":304,"type":21},328,[24],"The project is a pragmatic registry-based RCT aiming to investigate ACL injury treatment. Study results will help fill knowledge gaps, facilitate shared decision making and strengthen patient treatment.\n\nIncluded patients will be randomized to (1) early ACL surgery followed by rehabilitation or (2) active rehabilitation with optional delayed surgery if indicated.\n\nRandomization and data collection is conducted through the Norwegian National Knee Ligament Registry (NNKLR) which is a well established population based ACL registry. Participation is based on informed consent to participate in the NNKLR and the registry-based RCT. The study uses the platform and outcome measures of the NNKLR to collect and measure data. The data will be stored as usual in the NNKLR, but RCT specific data will be exported for analysis and stored inTjenester for sensitive data (TSD). Data collected in NNKLR are: patient data (age, height, weight, activity level, smoking-and snuff habits), knee injury data (injury data, injury mechanism, additional knee injury), treatment (non-operative or ACL reconstruction, reoperation), surgical details (operation date, antibiotics, anti-coagulants, graft type and size, approach for femoral tunnel, additional injury and additional surgical procedure) and patient reported knee function at baseline, 2, 5 and 10 years. Also, x-rays and MRIs will be imported for included patients and stored in TSD.",[308],"Anterior Cruciate Ligament Injuries",[310,311,312,313,314,315,316],"acl","anterior cruciate ligament injury","anterior cruciate ligament rupture","anterior cruciate ligament tear","secondary meniscal tear","ACL reconstruction","ACL rehabilitation","2025-01-27",{"date":319,"type":36},"2025-01-28",{"date":321,"type":36},"2021-04-29",{"date":323,"type":21},"2045-12",{"name":42,"class":43},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":87,"sex":333,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":338,"conditions":339,"keywords":343,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":78},"100572339","the-follow-up-after-shorter-tapes-study-effectiveness-and-safety-of-shorter-trans-obturator-tapes-100572339","NCT06731985","The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes.","The FAST- Study: The Follow-up After Shorter Tapes Study Effectiveness and Safety of Shorter Trans-obturator Tapes: A Prospective Observational Study From the Norwegian Female Incontinence Registry","FAST","Inclusion Criteria:\n\n* All women operated for stress-urinary incontinence with TVT-O Abbrevo of Ajust incontinence sling between 2009 and 2020.\n\nExclusion Criteria:\n\n* Women operated with other incontinence operations or slings.","FEMALE","25 Years","90 Years",{"count":337,"type":21},750,"Urinary incontinence after pregnancy and labor affects 1 in 3 women and has a negative impact on quality of life (QOL), limiting women's physical activity and impairing sexual function. The traditional surgical method treating female urinary incontinence is to implant a sub-urethral synthetic sling, the currently preferred method in Norway. The majority of women treated with synthetic slings obtain great improvement in QOL, but a few experience severe complications including chronic pelvic pain. Several countries, therefore, have reverted to older, less effective surgical methods to avoid synthetic material. Awareness of severe complications has, in some Norwegian hospitals, led to a shift in technique towards shorter slings. With shorter slings, the goal is to achieve the same grade of continence as traditional slings, but with fewer serious complications. The long-term results and complications of these shorter slings are mostly unknown. Akershus University Hospital (AHUS) shifted to shorter slings early, in 2009, using a single incision mini-sling (SIMS) Ajust. Due to costs, AHUS changed to the intermediate sling TVT-O Abbrevo in 2016.\n\nThrough this study, we hope to establish if shorter slings have the same long-term results as traditional slings, and to investigate if shorter slings are safer than traditional slings, with less long-term complications, such as chronic pelvic pain. We plan to perform a long-term follow-up of women having had surgery with shorter slings at AHUS.\n\nAll patients operated with either SIMS Ajust or TVT-O Abbrevo at AHUS between 2009 and 2020 will be invited to a long-term follow-up. The study participants will be asked to fill in validated questionnaires regarding symptoms of urine leakage, QOL, any chronic pain related to the surgery, debut of pain, level of pain and any treatments for the pain. All women treated with the current used sling Abbrevo is invited to a physical examination including testing of their voiding function and a gynecologic examination to check for complications.\n\n2D- and 3D ultrasound scans will be done on the TVT-O Abbrevo group to evaluate the position-, attachment- and any misplacement of the sling.\n\nWomen experiencing insufficient long-term results, such as chronic pain, will be offered a full examination and treatment.",[340,341,342],"Stress Urinary Incontinence","Postsurgical Pain","Follow-Up Studies",[344],"Long-term Follow-Up of shorter incontinence tapes","2024-12-09",{"date":347,"type":36},"2024-12-13",{"date":349,"type":36},"2024-10-24",{"date":351,"type":21},"2026-10-31",{"name":42,"class":43},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":194,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":78},"100518605","brief-intervention-for-sleep-medication-misuse-among-elderly-100518605","NCT06032715","Brief Intervention for Sleep Medication Misuse Among Elderly","Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly","BI-sleep","Inclusion Criteria:\n\n* Self-reported use of Z-hypnotics \\> 4 days per week and \\> 4 weeks\n\nExclusion Criteria:\n\n* diagnosis of dementia,\n* diagnosis of psychosis,\n* diagnosis of major depression,\n* diagnosis of delirium,\n* unable to give informed consent,\n* insufficient Norwegian language capacity to complete tests",{"count":362,"type":21},120,[24],"Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.",[366],"Harmful Use of Hypnotic",[368,369,370,371,372,373,374,375,376],"Z-hypnotics","insomnia","sleep","side effects","cognitive function","pain","behavioral intervention","dependence","quality of life","2024-11-13",{"date":379,"type":36},"2024-11-15",{"date":381,"type":36},"2023-10-09",{"date":383,"type":21},"2025-06-30",{"name":42,"class":43},{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":78},"100470091","tailoring-treatment-in-colorectal-cancer-100470091","NCT05401318","Tailoring Treatment in Colorectal Cancer","Pilot Study for Ex Vivo Tailoring of Treatment in Colorectal Cancer","TargetCRC","Inclusion Criteria:\n\n* Histologically confirmed colorectal cancer scheduled for curative surgery and standard clinical follow-up.\n\nExclusion Criteria:\n\n\\- Unable\u002Funwilling to sign the informed consent form.",{"count":394,"type":21},40,"In this study, the investigators will establish a reliable method and logistic pipeline for personalized drug testing ex vivo using fresh tumor samples from colorectal cancer (CRC) patients. With this, the investigators aim to develop a novel predictive biomarker of immunotherapy response, by testing combinations of chemotherapies and chimeric antigen receptor (CAR) T cells. Critically, this affects a large subgroup of patients currently not considered to benefit from such treatment. To support the hypothesis, the project will make use of cutting-edge, cell-based functional diagnostics. Individual patients' cancer cells will be screened against a panel of chemotherapies and targeted therapies including CAR T cells, to assess the optimal combination of therapies to induce immunotherapy efficacy in otherwise unresponsive CRC.",[397],"Colorectal Neoplasms",[399,400,401,402,403,404,405],"Leucovorin","Oxaliplatin","Fluorouracil","Immunotherapy","Colorectal cancer","CAR T-cells","Patient-Derived Organoids","2024-08-04",{"date":408,"type":36},"2024-08-06",{"date":410,"type":36},"2022-03-28",{"date":412,"type":21},"2027-01-01",{"name":42,"class":43},{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":4},"100554420","saline-infusion-test-in-hyponatremia-100554420","NCT06498856","Saline Infusion Test in Hyponatremia","SITH","Inclusion Criteria:\n\n* Plasma sodium 120-130 mmol\u002FL\n* Effective osmolality (2 x plasma sodium + plasma glucose) \\\u003C 275 milliosmol\u002FL\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Intensive care unit (ICU) admission\n* Adequate sodium correction rate: \\> 4 mmol\u002FL last 24 hours\n* Primary polydipsia: urine osmolality \\\u003C 100 mOsm\u002FL\n* Hypertonic saline therapy\n* Adrenal insufficiency\n* Severe heart failure: ejection fraction \\\u003C 35 % or clinical suspicion of decompensated heart failure\n* Ascites grade 3 (marked abdominal distention and discomfort)\n* Chronic renal failure stage 4 or 5: estimated glomerular filtration rate \\\u003C 30\n* Failure to submit informed consent",{"count":422,"type":21},100,"Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.",[425],"Hyponatremia",[427,428,429,430,431,432,433],"Arginine vasopressin","Copeptin","Antidiuretic hormone","Saline infusion test","Fluid- and volume regulation","Renin","Aldosterone","2024-07-05",{"date":436,"type":36},"2024-07-12",{"date":438,"type":21},"2024-07",{"date":440,"type":21},"2028-12",{"name":42,"class":43},{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":17,"minAge":449,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":78},"100508740","a-study-to-improve-the-collaboration-between-primary-and-secondary-health-care-on-the-treatment-of-osteoporosis-after-a-hip-fracture-100508740","NCT05904353","A Study to Improve the Collaboration Between Primary and Secondary Health Care on the Treatment of Osteoporosis After a Hip Fracture.","Collaboration to Improve Bone Health","Inclusion Criteria:\n\n* Patients 75 years or older with a hip fracture\n\nExclusion Criteria:\n\n* Refuse treatment\n* Another treatment of osteoporosis is indicated\n* Guest patient, do not live in the admission area\n* Dementia","75 Years",{"count":451,"type":21},200,[24],"This is a study to improve the collaboration between primary and secondary health care on the treatment of osteoporosis after a hip fracture. In Akershus University Hospital, patients 75 years or older with a hip fracture, are offered treatment with an infusion of zoledronic acid 5mg, combined with vitamin D and calcium supplements, to prevent new fractures. General practitioners (GPs) are requested to take care of the follow-up on this treatment with annual infusions of zoledronic acid for 3 years.\n\nIn the opinion of the investigators, it is expedient, safe, and sensible for parts of the subsequent treatment to be provided by GPs. If hospitals take responsibility for initiating the treatment, the investigators believe that most of the subsequent monitoring and continuance of treatment can be conducted by the primary healthcare service. Despite this, the investigators suspect that many patients do not get their annual infusions of zoledronic acid after discharge from the hospital.\n\nThis quality assurance study aims to test a new system where ambulant nurses from the hospital support the GP in treating osteoporosis with the administration of zoledronic acid in the following 3 years after femoral neck fractures. Through the project, the investigators will create procedures for the administration and follow-up of zoledronic acid fitted in the setting of the GP office.\n\nThe design is a cluster randomized controlled study (RCT) where the regions are prospectively randomized to either intervention or control regions. Patients ≥ 75 years, which suffer a femoral neck fracture, are identified in our Department of Orthopedic Surgery, where they are provided the first infusion of zoledronic acid 5 mg and proposed participation in the study. Patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid. Patients from the control regions are offered the usual care. Both patients from the control and intervention regions are asked to fill out a questionnaire after 1 year. The questionnaire will ask if the patient has got zoledronic acid as encouraged in the medical journal after discharge from the hospital. The primary study outcome is if the patients are offered treatment at a one-year follow-up or not.\n\nSample size calculation estimates a total sample of 130 patients based on a minimal clinically important difference of 20% follow-up between the groups. Because of high mortality, the investigators estimate the need for 200 patients.\n\nThe investigators hypothesize that the one-year follow-up is better in the intervention group than in the control group.",[455,456,457,458,459],"Hip Fractures","Osteoporosis","Zoledronic Acid","Ambulant Nurse","Case Manager","2024-02-02",{"date":462,"type":36},"2024-02-05",{"date":464,"type":36},"2024-01-01",{"date":466,"type":21},"2026-12",{"name":42,"class":43},{"id":469,"slug":470,"hasResults":11,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":333,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":480,"conditions":481,"keywords":486,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":500,"locationsCount":78},"100495504","phase-2-nicotinamide-riboside-and-prevention-of-cancer-therapy-related-cardiac-dysfunction-in-breast-cancer-patients-100495504","NCT05732051","Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients","Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines","NARNIA","Inclusion Criteria:\n\n* Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy\n* Eastern Cooperative Oncology Group performance status 0-2\n\nExclusion Criteria\n\n* Age \\\u003C18 years\n* Acute myocardial infarction within the last three months\n* Participation in another pharmaceutical clinical trial of an investigational medicinal product (IMP) less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer\n* Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers\n* Life expectancy \\\u003C 6 months\n* Known allergy to any of the components in the Nicotinamide Riboside (Niagen®) tablet\n* Contraindications or inability to undergo CMR examination",{"count":477,"type":21},60,[479],"PHASE2","Breast cancer is the most common form of cancer in women. Modern breast cancer treatments have led to increased survival, but at the same time, increased risk for cardiotoxicity and development of heart failure. In this study, the investigators want to evaluate whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. Further, the investigators will evaluate change in signs of skeletal muscle injury and functional capacity.",[482,483,484,485,27],"Breast Cancer","Metastatic Breast Cancer","Cancer Therapy-Related Cardiac Dysfunction","Cardiotoxicity",[482,487,488,489,490,491,492,493,485,484],"Anthracyclines","Niagen","Nicotinamide riboside","Nicotinamide adenine dinucleotide","Reactive oxygen species","Cardiac Dysfunction","Cardio-oncology","2023-03-16",{"date":496,"type":36},"2023-03-17",{"date":494,"type":36},{"date":499,"type":21},"2035-09-30",{"name":42,"class":43},{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":87,"sex":17,"minAge":194,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":515,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":78},"100370693","two--part-proximal-humerus---conservative-vs-operative-100370693","NCT04106674","Two- Part Proximal Humerus - Conservative vs Operative","Conservative Versus Operative Treatment of Two - Part Proximal Humerus Fractures","-The study-design is a single center single blinded randomized controlled trial (RCT) with 3 arms. Patients admitted to Akershus University Hospital with a displaced 2-part proximal humeral fracture of OTA\u002F AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative\u002F non-operative treatment or open reduction and internal fixation (ORIF). The patients allocated to ORIF will be randomly allocated to either the Philos plate (Synthes) or the Multiloc nail (Synthes).\n\nInclusion criteria\n\n1. Patients \\> 60 years and \\\u003C85 years\n2. More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).\n3. Patient with tuberculum majus or minor fractures which displaced \\\u003C5mm can be included as long as points 1 and 2 above are fulfilled.\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Fracture more than 3 weeks old\n* No contact btw head and shaft\n* Ipsilateral damage that will influence the recovery and scoring systems\n* Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide\n* Pathological fracture or previous fracture of the same proximal humerus\n* Multitrauma or \"multifractured patient\"\n* Neurovascular injury\n* Open fracture\n* Noncompliance, dementia and\u002F or institutionalized\n* Congenital anomaly\n* Ongoing infectious process around the incision site for osteosynthesis\n* Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis\u002FMultiple sclerosis\u002F poorly controlled DM)\n* Fracture dislocation\n* Substance abuse\n* Inability to read and understand Norwegian\n* Patients not residing in our catchment area\n* Patients with a diameter of the humerus to small for nailing, will be allocated to the Philos-group.\n* Any medical condition that excludes surgical treatment, including patients with ASA 3 or 4 that are considered too ill to go through surgery.","85 Years",{"count":112,"type":21},[24],"The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?",[513,514],"Proximal Humerus Fracture","2 Part Fracture",[516,517,518,519],"Proximal humerus fracture","Non-operative versus operative treatment","Conservative versus surgical treatment","Surgical versus non-surgical treatment","2022-10-24",{"date":522,"type":36},"2022-10-25",{"date":524,"type":36},"2020-10-01",{"date":526,"type":21},"2034-10-31",{"name":42,"class":43},{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":534,"targetDuration":536,"studyType":91,"phases":4,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":78},"100388284","covid-19-in-hospitalised-norwegian-children---risk-factors-outcomes-and-immunology-100388284","NCT04335773","COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology","Inclusion Criteria:\n\nSuspected covid-19 infection and age 0-18 years\n\nExclusion Criteria:\n\nAge \\>18 years",{"count":535,"type":21},350,"6 Months","Prospective cohort study of COVID-19 infection among children in Norway.",[539,540,94],"Pediatric Respiratory Diseases","COVID","2022-02-14",{"date":543,"type":36},"2022-02-16",{"date":545,"type":36},"2020-04-03",{"date":547,"type":21},"2030-12-31",{"name":42,"class":43},{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":17,"minAge":194,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":78},"100441189","phase-2-precision-therapy-versus-standard-therapy-in-aml-and-mds-in-elderly-100441189","NCT05025098","Precision Therapy Versus Standard Therapy in AML and MDS in Elderly","Precision Therapy Versus Standard Therapy in Acute Myeloid Leukaemia and Myelodysplastic Syndrome in Elderly","PALM","Inclusion Criteria:\n\n* Patients with a diagnosis of AML and related precursor neoplasms according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease and therapy-related AML (not if they have received antileukemic\u002Fmds treatment)), or\n* acute leukemias of ambiguous lineage according to WHO 2016 or a diagnosis of myelodysplastic syndrome (MDS) with IPSS-R \\> 4.5.1\n* Patients 60 years and older.\n* Patients must NOT be eligible for intensive chemotherapy or allogeneic stem cell therapy (See Chapter 23.3)\n* WBC ≤ 25 x109\u002FL (prior hydroxyurea allowed for a maximum of 14 days, stopped before start of treatment)\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n* WHO performance status 0, 1 or 2 for subjects ≥ 75 years of age OR 0 to 3 for subjects ≥ 60 to 74 years of age.\n* Life-expectancy above 3 months\n* Signed Informed Conscent\n* Male Subjects Only: Male subjects who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice contraception with condom. Male subjects must agree to refrain from sperm donation from initial study drug administration until at least 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia.\n* AML with favourable cytogenetic or genetic changes in patients who are fit for intensive chemotherapy. Favourable genetics are: t(8;21)(q22;q22.1); RUNX1-RUNX1T1; inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11; mutated NPM1 without FLT3-ITD or with FLT3-ITDlow†; Biallelic mutated CEBPA\n* Patients previously treated for AML or MDS (any antileukemic therapy or MDS treatment including investigational agents).\n* Patients where it is not possible to get bone-marrow for NGS, i.e., \"dry tap\".\n* Diagnosis of any previous or concomitant malignancy is an exclusion criterion: except when the patient completed successfully treatment (chemotherapy and\u002For surgery and\u002For radiotherapy) with curative intent for this malignancy at least 6 months prior to randomization.\n* Blast crisis of chronic myeloid leukemia.\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)\n* Cardiac dysfunction as defined by:\n\n  * Unstable angina or\n  * New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue,palpitations, dyspnea, or angina pain or\n  * Unstable cardiac arrhythmias\n* Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance with the study protocol and follow-up schedule.\n* Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.\n* Patients who do not understand the Written Informed Consent (e.g., language problems)\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.\n* Subject is known to be positive for HIV (HIV testing is not required).\n* Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required).\n* AML subjects that has received strong and\u002For moderate CYP3A inducers within 7 days prior to the initiation of venetoclax treatment.\n* Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. Additional exclusion criteria at the time of randomization\n* WHO performance status \\> 2 for subjects ≥ 75 years of age OR \\> 3 for subjects ≥ 60 to 74 years of age.\n* Progressive disease according to ELN criteria (see chapter 12 Response evaluation)\n* Initial treatment has made the patient eligible for allogeneic stemcell transplantation\n* In addition, it will be specific exclusion criteria for the patients receiving targeted therapies related to the Summary of Product Characteristics (SPC) of each drug.",{"count":558,"type":21},36,[479],"This is a randomized clinical trial that randomizes between treatment principles. The study will investigate if precision therapy determined by a tumour board is better than standard treatment for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) in elderly. The tumour board will decide the precision therapy based on identified genetic changes that can guide customized therapy. There are currently 40-50 targeted therapies approved for various cancers in Norway. The precision therapy will be given in addition to the standard treatment.\n\nThe primary study objective will be to evaluate the cost-effectiveness of a precision therapy strategy compared with standard treatment. Other objectives will mesaure efficacy and satety of the treatment, and impact on life quality of the patients.",[562,563],"AML, Adult","MDS","2021-08-23",{"date":566,"type":36},"2021-08-27",{"date":568,"type":36},"2021-06-22",{"date":570,"type":21},"2027-06-10",{"name":42,"class":43},""]