[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vestre Viken Hospital Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":476},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,48,87,115,144,168,193,217,241,267,290,316,338,362,392,428,453],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100541709","total-underwater-colonoscopy-tuc-for-improved-colorectal-cancer-screening-a-randomized-controlled-trial-100541709",false,"NCT06333392","Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial","Inclusion Criteria:\n\n* All individuals referred to colonoscopy after a positive FIT screening at the participating screening centres\n\nExclusion Criteria:\n\n* Individuals with a CRC diagnosis within the last 10 years.","ALL","55 Years","60 Years",{"count":19,"type":20},1070,"ESTIMATED","INTERVENTIONAL",[23],"NA","Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:\n\n1. SSLs will be more visible as they \"float\" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.\n2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.\n3. uEMR is eased.\n4. Improved bowel cleansing\n\nThe goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.\n\nThe overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.\n\nThe project has five main hypotheses:\n\n1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.\n2. TUC increases the rate of complete resection of lesions \\>= 10mm.\n3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.\n4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.\n5. TUC reduces the carbon footprint by reduced use of single use accessories.\n\nIf TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.\n\nThe trial can be linked to three of the Global Goals:\n\n* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).\n* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.\n* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced.",[26,27,28,29,30],"Colorectal Neoplasia","Screening Colonoscopy","Colorectal Cancer","Colorectal Cancer Screening","Vasovagal Reaction",[32,33,34],"colorectal cancer screening","screening colonoscopy","underwater colonoscopy","RECRUITING","2025-12-12",{"date":38,"type":39},"2025-12-19","ACTUAL",{"date":41,"type":39},"2024-10-23",{"date":43,"type":20},"2027-06",{"name":45,"class":46},"Vestre Viken Hospital Trust","OTHER",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100608373","effect-study-of-smart-treatment-for-youth-100608373","NCT07200713","Effect Study of SMART Treatment for Youth","A Randomized Controlled Evaluation of Sensory Motor Arousal Regulation Treatment (SMART) for Youth With Developmental Trauma and Self-regulation Difficulties","UTVID","Inclusion criteria:\n\nThese are based on the Developmental Trauma Disorder Semistructured Interview (DTD-SI), which has four domains (A-D). Based on the DTD-SI, which is detailed below, inclusion requires:\n\n* The presence of developmental trauma history (domain A)\n* One symptom in each of the domains B-D\n* At least four symptoms (of a maximum 15) in domains B-D considered together\n\nDomains A to D above refers to the following:\n\n* Domain A. Lifetime contemporaneous exposure to developmental trauma, defined as either (i) Interpersonal victimization: physical or sexual abuse or assault, domestic\u002Fintimate partner violence, bullying, harassment, exploitation, trafficking, hate crimes, or racial\u002Fethnic\u002Fidentity trauma, or (ii) Primary caregiving system attachment disruption: caregiver change or prolonged separation, gross neglect (physical, medical, emotional), psychological maltreatment (emotional abuse, emotional neglect, parental hostility or over-controlling), caregiver impairment due to mental illness or substance abuse, or chronic medical condition (by child or caregiver)\n* Domain B. Affective and somatic dysregulation: (i) Emotion dysregulation, (ii) Somatic dysregulation, (iii) Impaired awareness or dissociation of emotions and body, (iv) Impaired capacity to describe emotions or bodily states\n* Domain C. Attentional and behavioral dysregulation: (i) Threat-related rumination, (ii) Impaired capacity for self protection, (iii) Maladaptive self-soothing, (iv) Habitual or reactive self-harm, (v) Inability to initiate or sustain goal-directed behavior\n* Domain D. Self and relational dysregulation: (i) Persistent extreme negative self-perception, (ii) attachment insecurity and disorganization, (iii) Extreme persistent distrust, defiance or lack of reciprocity in close relationships, (iv) Reactive physical or verbal aggression, (v) Psychological boundary deficits, (vi) Impaired capacity to regulate empathic arousal\n\nExclusion Criteria:\n\n* Active psychosis\n* Not fluent in Norwegian language\n* Developmental challenges - IQ \\\u003C 70\n* Has previously used SMART room","7 Years","17 Years",{"count":59,"type":20},120,[23],"The goal of this clinical trial is to learn if Sensory motor arousal regulation treatment (SMART) works better than treatment as usual (TAU) to treat youth 7-17 years with complex trauma histories and self-regulation difficulties. The study also will investigate which patients will benefit more from SMART (treatment effect heterogeneity) and whether therapeutic alliance mediates effect. The main hypotheses the trial aims to answer are:\n\n1. Main effects: The SMART model approach will be more effective than ordinary treatment (control condition), in terms of improvement from therapy starts to 6 and 12 months follow up, for:\n\n   1. Regulatory capacities of emotions and bodily states, attention and behavior, and self and social relations\n   2. Trauma symptoms of re-experiencing, avoidance\u002F numbness and hyperarousal and sense of threat (core PTSD symptoms) and disturbances in self-organization (affect, self-concept; relations - core complex PTSD symptoms)\n   3. Internalizing symptoms (somatic complaints, anxiety symptoms and depression symptom severity) and Externalizing symptoms (conduct problems, aggression, inattention, and social problem severity)\n   4. Psychosocial strengths - prosocial behavior, subjective well-being and impairment in peer relationships, family relationships, and academic\u002Fschool functioning\n2. Exploration of mediation: When comparing SMART and ordinary treatment (TAU), (i) therapeutic alliance is higher in SMART, and (ii) a better treatment effect in SMART is partially mediated by therapeutic alliance\n\n3\\. Exploration of treatment effect heterogeneity (moderators): Effects of SMART treatment compared to TAU vary between: patients with low versus high level of self-regulation difficulties (full vs partial Developmental trauma disorder), patients with extensive vs less extensive developmental trauma exposure, adolescents (13-17 years) vs younger children (7-12 years), and patients exposed to trauma early in life vs in their teens\n\nAt each site, eligible participants are randomized to SMART or ordinary treatment\u002F TAU. Investigators acquire study data at baseline and outcome data at follow up after 6 and 12 months, and measure therapeutic alliance twice during the treatment process.",[63,64,65,66],"Stress Disorders, Traumatic","Psychological Trauma","Sexual Trauma","Stress Disorders, Post-Traumatic; Mental Disorders",[68,69,70,71,72,73,74,75,76],"Randomized controlled trial","Developmental trauma disorder","self-regulation difficulties","trauma treatment","Sensory motor arousal regulation treatment (SMART)","Children","Youth","Outpatient treatment","Treatment as usual","NOT_YET_RECRUITING","2025-09-22",{"date":80,"type":39},"2025-10-01",{"date":82,"type":20},"2025-09-25",{"date":84,"type":20},"2027-12-31",{"name":45,"class":46},4,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":15,"minAge":94,"maxAge":17,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100587745","a-talus-implant-in-patients-between-20-60-years-of-age-followed-up-for-a-minimum-of-2-years-after-surgery-100587745","NCT06932380","A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery","A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery: A Pilot Study","Inclusion Criteria:\n\n* Patients aged 20-60 years with symptomatic osteochondral lesions of the ankle where conservative treatment or previous surgery has been unsatisfactory.\n* Patients with a limited cartilage defect that qualifies for Episealer implantation.\n* Patients who have provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with an active infection in the ankle.\n* Patients with extensive cartilage damage where Episealer is not indicated.\n* Patients with osteoarthritic changes on the tibial side of the ankle joint.\n* Patients with severe joint instability.\n* Patients with severe neurological or systemic diseases.\n* Patients who smoke.\n* Patients with substance abuse issues.\n* Patients unable to attend follow-ups due to distance or other factors.","20 Years",{"count":96,"type":20},10,[23],"The project will investigate safety, feasibility and efficiency when using Episurf Episeal talus implant in patients with osteochondral ankle injuries. Assessments includes revision rate, complications, pain, function and quality of life over two years. Ten patients (aged 20-60) who have not responded to previous treatment will participate based on informed and written consent. The project uses a prospective cohort design where the patients receive a customized surgical procedure. Data on clinical function, pain and patient satisfaction collected using the AOFAS ankle score, NRS and EQ-5D-5L questionnaire at 6 weeks, 6 months, 1 year and 2 years after the operation. The study can provide valuable insight into the treatment of ankle osteoarthritis, improve the patient's quality of life and function, and represent a step forward in orthopedic surgery, especially for younger, active patients. The results are shared with it the medical community and the general public through publications and presentations.",[100],"Cartilage Lesion",[102,103,104,105],"focal cartilage injury","ankle cartilage","patient-specific implant","pilot study","2025-04-24",{"date":108,"type":39},"2025-04-29",{"date":110,"type":39},"2024-10-01",{"date":112,"type":20},"2030-12-31",{"name":45,"class":46},1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100586581","wrist-and-carpal-arthrodeses-a-1-year-follow-up-study-100586581","NCT06917235","Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.","Inclusion Criteria:\n\n* All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.\n* Advanced degenerative changes unresponsive to conservative treatment.\n\nExclusion Criteria:\n\n* Patients who do not accept participation in the study",{"count":122,"type":20},20,"OBSERVATIONAL","This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Arthrodesis, which fuses two or more bones to eliminate joint mobility, is considered as a last resort when conservative treatments do not produce the desired results. The study includes patients with advanced degenerative changes, rheumatoid arthritis, or extensive injuries. Patients assessed preoperatively and postoperatively through measurements of range of motion, grip strength, and pain using various tools such as PRWHE, QuickDASH, EQ-5D-5L and NRS. The checks include X-rays and CT to evaluate healing. The data is analyzed to identify trends and factors that influence positively outcome. The follow-up takes place after 8 weeks, 3 months and 1 year postoperatively, with a focus on pain relief and functional improvement. The data are compared before and after surgery to assess the effectiveness of the intervention efficiency. The study has been applied for approval by REK, but rejected because it was assessed as a quality control project, and applied for the Data Protection Commissioner (PVO).\n\nThe data is anonymised and stored on secure servers, with switch keys stored separately. The patients give informed consent and are insured through Norwegian Patient Injury Compensation. The study seeks to improve patient care by increasing understanding of the long-term effects of osteoarthritis, including complications and secondary osteoarthritis. The results will contribute to better clinical decisions and treatments.",[126,127,128],"Arthrodesis","Arthrosis","Wrist Osteoarthritis",[130,131,132,133,134],"Wrist arthrodesis","carpal arthrodesis","follow-up","surgery","fusion","2025-04-09",{"date":137,"type":39},"2025-04-13",{"date":139,"type":39},"2024-09-01",{"date":141,"type":20},"2029-08-15",{"name":45,"class":46},2,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":15,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":114},"100586183","a-needle-technique-for-achilles-tendon-lengthening-in-pediatric-patients-a-prospective-study-on-efficacy-safety-and-feasibility-100586183","NCT06912061","A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility","Inclusion Criteria:\n\n* Age: 5-16 years\n* Consent from parents\u002Fguardians\n* Indication for Achilles tendon lengthening (toe walking, spasticity), both unilateral and bilateral:\n* Equinus foot with dorsiflexion ≤ 0 degrees with the knee extended and the heel in neutral position.\n* Symptomatic equinus foot, meaning a foot position causing pain, discomfort, increased fatigue, etc.\n\nExclusion Criteria:\n\n* Unwillingness to participate, lack of consent\n* Previous surgical Achilles tendon lengthening, e.g., for clubfoot\n* Received BoNT-a injection in the triceps surae within the last 6 months\n* Contracture in the ankle joint, i.e., equinus position not due to a tight Achilles tendon\n* Positive Silfverskiöld test and dorsiflexion \\> 5 degrees with the knee extended (indicating the need for gastrocnemius recession)\n* Concurrent other surgery\u002Fother procedures on the same lower extremity, including BoNT-a injection","5 Years","16 Years",{"count":153,"type":20},50,[23],"For years, we have used a minimally invasive and biological variant of Achilles tendon lengthening using a needle inserted into the Achilles tendon so that it is weakened and can be gradually stretched to the desired length. So far, no negative effects, complications or tendon problems have been observed. A prospective study of a cohort of children and adolescents is planned where there is an indication for Achilles lengthening, such as spastic or non-spastic contracture and toe walking that results in an unwanted shortening of the Achilles tendon that makes walking difficult. We plan to include up to 50 children and adolescents over a two-year period and follow them closely for the first year after surgery. Pediatric physiotherapists will perform all clinical examinations to limit observer bias, and a radiologist will examine the tendon tissue with ultrasound before and one year after surgery to check anatomical conditions. The study will examine safety, effectiveness and feasibility of using the method, and anatomy, patient satisfaction and quality of life.",[157],"Equinus Contracture",[159,160,161],"Idiopathic toe walking (ITW)","Tendon Achilles Lengthening (TAL)","needle technique",{"date":137,"type":39},{"date":164,"type":39},"2025-01-01",{"date":166,"type":20},"2027-08-31",{"name":45,"class":46},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":15,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":192,"locationsCount":114},"100585748","health-related-quality-of-life-in-children-and-adolescents-with-clubfoot-100585748","NCT06906406","Health-Related Quality of Life in Children and Adolescents With Clubfoot","Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study","Inclusion Criteria:\n\n* Children aged 2 to 15 years diagnosed with congenital clubfoot.\n* Undergoing treatment or follow-up at Drammen Hospital.\n* Both unilateral and bilateral cases included.\n* Written informed consent from parents or legal guardians.\n\nExclusion Criteria:\n\n* Concurrent severe medical or psychological conditions affecting outcomes.\n* Lack of written informed consent.\n* Incomplete or missing data for PedsQL or PBS assessments.","2 Years","15 Years",{"count":178,"type":20},30,"This prospective cohort study aims to evaluate the health-related quality of life (HRQoL) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the Ponseti method. The study will assess HRQoL using the Pediatric Quality of Life Inventory (PedsQL 4.0) and clinical outcomes using the PBS Clubfoot Score (PBS). Participants will be followed for 2 and 5 years to evaluate changes in HRQoL and clinical function. The primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.",[181,73,182],"Clubfoot","HRQOL (Health Related Quality Of Life)",[184,185,73,181,186],"HRQoL","PedsQL","Ponseti","2025-03-28",{"date":189,"type":39},"2025-04-02",{"date":164,"type":39},{"date":112,"type":20},{"name":45,"class":46},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":114},"100572831","digital-secondary-prevention-after-atherosclerotic-cardiovascular-disease-100572831","NCT06738381","Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease","Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study","Inclusion criteria (all the following):\n\n* Aged \\>=18 years and signed informed consent and expected cooperation according to ICH\u002FGCP and national\u002Flocal regulations\n* Hospitalised with an planned or unplanned ASCVD event and\u002For established atherosclerosis\n* Access to a smartphone or tablet\n\nExclusion criteria (any of the following):\n\n-Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to: cognitive impairment, seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.\n\n* Short life expectancy (\\\u003C12 months) due to end-organ (i.e COPD 4, CKD 4\u002F5) or malignant diseases\n* Clinically significant symptoms of anxiety and depression (HADS A and\u002For HADS-D score ≥8)\n* Not being able to understand Norwegian.","18 Years",{"count":202,"type":20},300,[23],"Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality worldwide and in Norway. Approximately 50% of the patients admitted to hospitals with an acute ASCVD event has had a previous event. The high number of patients being readmitted to hospitals with new ASCVD events is to a large degree explained by poor control of established risk factors such as high LDL-cholesterol, high blood pressure (BP), diabetes, obesity, smoking, and lack of physical activity, as well as poor adherence to evidence-based medication. This pragmatic, open-label proof-of-concept study conducted at three secondary care hospitals will randomly assign patients hospitalized with an ASCVD event to either: (i) brief advice, tailored discharge information to general practitioners, and a nurse-led outpatient visit (control), or (ii) the same interventions as (i) plus a single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information\u002Fvideos and an individualized treatment plan and follow-up plan. The primary end point will be between-group differences in the proportion who report having attended follow-up visits in primary (primary care physicians and community-based healthy life centres) and specialist (cardiac rehabilitation programs, hospital outpatient visits) healthcare after 8 weeks and 6 months follow-up. Secondary end points will be change in the SMART2 risk score and cardiovascular risk factors between baseline and 6 and 12 months follow-up. Exploratory end points will be changes in adherence to cardiovascular drugs, self-care behaviour, health literacy, patient activation, and quality of life.",[206,207,208],"Atheroscleroses, Coronary","Atheroscleroses, Cerebral","Atherosclerotic Ischemic Disease","2025-02-19",{"date":211,"type":39},"2025-02-21",{"date":213,"type":39},"2025-02-03",{"date":215,"type":20},"2026-12-20",{"name":45,"class":46},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":114},"100573720","cognitive-behavioural-therapy-for-insomnia-in-patients-with-coronary-heart-disease-100573720","NCT06749951","Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease","Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease: A Randomized Controlled Trial With Six Months Follow-up","TreatSleepCHD","Inclusion criteria (all the following):\n\n* Aged 18-75 years and signed informed consent and expected cooperation according to ICH\u002FGCP and national\u002Flocal regulations\n* Hospitalised with acute myocardial infarction and\u002For angiography-verified coronary atherosclerosis, or a coronary revascularisation procedure at Drammen Hospital 2021-2024\n* A positive score for insomnia measured with Bergen Insomnia Score\n* At least 10 of 14 daily diaries completed of the sleep diary during pre-randomization assessment\n\nExclusion criteria (any of the following):\n\n* Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to:\n* Moderate or severe cognitive impairment (i.e. recorded in hospital records or a Montreal Cognitive Assessment brief version score \\\u003C 11), seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.\n* Neurological or musculoskeletal disorders that restrict movement of the dominant arm because of the possible confounding effects on wrist actigraphy recordings.\n* A diagnosis of heart failure recorded in the hospital medical records and\u002For an NT-proBNP \\>125 pg\u002FmL\n* Short life expectancy (\\\u003C12 months) due to end-organ (i.e COPD 4, CKD 4\u002F5) or malignant diseases\n* Not being able to understand Norwegian.\n* No other significant sleep disorder, as assessed via the Structured Clinical Interview for Sleep disorders (Kallestad et al., 2022)\n* A clinical diagnosis of Obstructive Sleep Apnea (OSA) (not treated with CPAP) recorded in the hospital medical records, under evaluation for OSA, and\u002For a score ≥5 on the STOP-Bang OSA screening questionnaire","75 Years",{"count":227,"type":20},76,[23],"Insomnia is prevalent (45%) in CHD patients and associated with significantly increased risk for recurrent cardiovascular events. Insomnia has recently been identified as the third most important risk factor for prognosis. However, very few insomnia patients are identified and receive treatment of insomnia today. CBT-I is the first-line treatment for insomnia, but studies on the effects in CHD patients are lacking. This project aims to document the effectiveness of Cognitive Behavioural therapy for insomnia (CBT-I) in an outpatient population with coronary heart disease (CHD). Furthermore, the biological and psychological mechanisms that may mediate the effects of the intervention will be identified. Finally, a health-economic simulation and a qualitative study of the participants experiences with CBT-I will be performed. This prospective, randomized, intervention study will continue until data have been collected for the primary outcome on 66 CHD outpatients with a diagnosis of insomnia assessed by Bergen Insomnia Scale (BIS). Participants will be randomised to a short, nurse-administered, CBT-I delivered in a group format or to sleep hygiene advice. The primary outcome will be remission from BIS-insomnia post-treatment and at 6-months follow-up. Secondary outcomes will be changes in insomnia severity, objective and subjective sleep parameters, daytime symptoms of insomnia, and quality of life. Exploratory outcomes include inflammation, cortisol, HbA1C, and cognitions\u002Fmetacognitions. The project may document the effectiveness of CBT-I for a large patient-group with potentially favorable long-term effects on important clinical outcomes.",[231,232],"Insomnia Chronic","Coronary Heart Disease","2025-01-07",{"date":235,"type":39},"2025-01-09",{"date":237,"type":39},"2024-12-30",{"date":239,"type":20},"2026-06-15",{"name":45,"class":46},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":114},"100569215","effectiveness-of-trauma-treatment-in-the-specialist-health-care-services-100569215","NCT06691347","Effectiveness of Trauma Treatment in the Specialist Health Care Services","Towards Evidence-based PTSD Care in Norwegian Specialist Health Services - A Randomized Controlled Trial","Inclusion Criteria:\n\n* age ≥18 years\n* meeting criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score ≥23\n\nExclusion Criteria:\n\n* insufficient mastery of the Norwegian language\n* severe intellectual impairment (estimated IQ of 70 or less)\n* comorbid psychiatric illnesses in an acute phase where other types of treatment need to be prioritized (e.g. hospitalization)\n* history of EMDR or CT-PTSD treatment",{"count":249,"type":20},270,[23],"Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients.\n\nThe main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.",[253,254,255,256,257,258],"Post Traumatic Stress Disorder PTSD","Quality of Life","Functional Outcome","Complex Post-Traumatic Stress Disorder","Eye Movement Desensitization and Reprocessing","Cognitive Therapy","2024-11-13",{"date":261,"type":39},"2024-11-15",{"date":263,"type":39},"2024-09-26",{"date":265,"type":20},"2030-12",{"name":45,"class":46},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":114},"100567990","screening-after-stroke---atrial-fibrillation-100567990","NCT06675383","SCREENING AFTER STROKE - ATRIAL FIBRILLATION","SCREENING AFTER STROKE - ATRIAL FIBRILLATION - the SIGNIFICANCE of TIMING and CHOICE of DEVICE","SAS-AF","Inclusion Criteria:\n\n* 18 years or older\n* Ischemic stroke\n* Without known AF or those with previously diagnosed paroxysmal AF exhibiting sinus rhythm upon admission\n\nExclusion Criteria:\n\n* AF at hosptial admission\n* Unable or unwilling to provide informed consent\n* A life expectancy of less than one year",{"count":276,"type":20},410,"As much as 20-30% of all strokes are attributed to atrial fibrillation (AF), making the detection of AF highly important, as AF-related strokes are largely preventable with optimal treatment. Therefore, most guidelines recommend screening patients for AF after a stroke, although the optimal timing and choice of monitoring device for screening remain undefined. Our aim is to investigate whether AF screening as early as possible after stroke symptom onset provides a higher detection rate compared to screening after discharge. Additionally, we aim to determine if a 3-lead ECG device provides a higher detection rate compared to a 1-lead patch recorder.",[279],"Atrial Fibrillation (AF)",[281],"Atrial fibrillation screening in acute stroke","2024-11-04",{"date":284,"type":39},"2024-11-05",{"date":286,"type":39},"2024-11-01",{"date":288,"type":20},"2033-12-31",{"name":45,"class":46},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":114},"100550226","integrated-health-care-for-patients-with-frailty-and-heart-failure-100550226","NCT06444321","INTEgRated Health CARE for Patients With Frailty and Heart Failure","INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project","INTERCARE-HF","Inclusion Criteria:\n\n* Age \\>18 years old\n* Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and\u002For other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening\n* Clinical Frailty Score ≥5\n* Signed informed consent by patient and closest relatives\\* and expected cooperation according to the protocol, ICH\u002FGCP and national\u002Flocal regulations\n\n  * Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium.\n\nExclusion Criteria:\n\n* Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures.\n* Not being able to understand Norwegian.\n* Permanent nursing home and estimated to stay alive for less than 6 months",{"count":299,"type":20},60,[23],"Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and \u002For outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) \\>=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.",[303,304,305,306,307,254],"Heart Failure","Frailty","Frail Elderly Syndrome","Symptom, Behavioral","Utilization, Health Care","2024-06-12",{"date":310,"type":39},"2024-06-13",{"date":312,"type":39},"2024-06-06",{"date":314,"type":20},"2028-12-20",{"name":45,"class":46},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":323,"minAge":200,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":114},"100495393","18f-fdg-petct-imaging-for-breast-cancer-100495393","NCT05730608","18F-FDG PET\u002FCT Imaging for Breast Cancer","Improving Breast Cancer Staging With 18F-FDG PET\u002FCT Imaging (The IMBRECAS PET Study)","Inclusion Criteria:\n\n* Patients with high risk primary or recurrent breast cancer\n* Non pregnant women \\> 18 years\n* Not receiving active treatment of other cancer types.\n* Eastern Cooperative Oncology Group (ECOG) status 0-2.\n\nExclusion Criteria:\n\n* Pregnant woman\n* Males\n* Age under 18\n* Patients receiving active treatment for other cancers\n* Poor general conditipon (ECOG 3 or higher)","FEMALE",{"count":202,"type":20},[23],"Purpose To investigate the ability of 18F-FDG PET\u002FCT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II\u002FIII and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.\n\nHypothesis The hypothesis is that 18F-FDG PET\u002FCT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II\u002FIII or locoregional recurrent BC.\n\nObjectives\n\nPrimary:\n\nTo evaluate if a 18F-FDG PET\u002FCT scan in the initial work up of patients diagnosed with stage II\u002FIII or locoregional recurrent BC will lead to change in staging and\u002For treatment.\n\nSecondary:\n\n* Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET\u002FCT scan compared with the patients with unchanged stage of disease following 18F-FDG PET\u002FCT.\n* Obtain size of the primary BC from CT\u002FMRI scan and evaluate if these metrics are correlated to outcome.\n* Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.\n* Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.\n* Blood and tumor samples for molecular characterisation:",[328,329],"Breast Cancer Female","Breast Cancer Recurrent","2024-05-08",{"date":332,"type":39},"2024-05-09",{"date":334,"type":39},"2023-02-16",{"date":336,"type":20},"2032-12-31",{"name":45,"class":46},{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":348,"conditions":349,"keywords":352,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":4},"100533880","digital-home-based-prehabilitation-before-surgery-100533880","NCT06231576","Digital Home-Based Prehabilitation Before Surgery","dHOPE","Inclusion Criteria:\n\n* Planned for major gastrointestinal cancer surgery\n* Fluent in Norwegian and able to consent and to understand questionnaires\n\nExclusion Criteria:\n\n* Inability to walk for six minutes or to rise independently from a chair\n* Inability to comprehend exercise program or to comply with written and oral instructions\n* Presence of a cardio-pulmonary condition that precludes exercise\n* Living in very remote areas making a hospital-based intervention group impossible to implement\n* Being without a permanent address\n* Admittance to a hospital facility for \\> 50% of the time from diagnosis to surgery",{"count":346,"type":20},140,[23],"This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.",[350,304,351],"Cancer Colorectal","Surgery",[353,354,304],"Prehabilitation","Colorectal cancer","2024-01-26",{"date":357,"type":39},"2024-01-30",{"date":359,"type":20},"2024-02-01",{"date":112,"type":20},{"name":45,"class":46},{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":378,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":143},"100531227","effect-of-nutritional-counseling-on-anthropometry-and-biomarkers-in-patients-diagnosed-with-schizophreniapsychosis-or-bipolar-affective-disorder-100531227","NCT06197048","Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia\u002FPsychosis or Bipolar Affective Disorder","A Randomized Controlled Trial on the Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia\u002FPsychosis or Bipolar Affective Disorder Treated at Asker DPS as Outpatients or Inpatients at Blakstad Hospital","Inclusion Criteria:\n\n* \\> 18 years\n* Diagnosed with either schizophrenia\u002Fpsychosis or bipolar affective disorder\n* Patients treatet in Vestre Viken healthcare company, at either Asker district psychiatric center or Blakstad hospital\n\nExclusion Criteria:\n\n* none",{"count":370,"type":20},40,[23],"The goal of this clinical trial is to compare the effect of nutritional counseling versus no treatment in patients with schizophenia or bipolar affective disorder.\n\nThe main question it aims to answer are:\n\n• Can nutritional counseling have a preventive effect on the development of cardiovascular disease in patients with schizophenia or bipolar affective disorder?\n\nParticipants will meet a nutritionist at baseline to asess nutritional status, biochemical and anthropometric measurements. Then, half of the study population will receive nutritional counseling. After six weeks, the same baseline measurements will be repeated to examine any potential differences between the two groups. After the intervention, the control group will be offered the same counseling as the intervention group received during the study.",[374,375,376,377],"Cardiovascular Diseases","Schizophrenia","Psychosis","Bipolar Disorder",[379,380,381,375,382,383],"Severe mental disorders","Nutritional counseling","Cardiovascular disease","Bipolar affective disorder","Randomzied controlled trial","2024-01-08",{"date":386,"type":39},"2024-01-09",{"date":388,"type":39},"2023-09-25",{"date":390,"type":20},"2028-12-01",{"name":45,"class":46},{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":15,"minAge":94,"maxAge":17,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":407,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":4},"100526385","finding-the-optimal-aim-of-correction-in-opening-wedge-high-tibial-osteotomy-100526385","NCT06134050","Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy","Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy Using 3D Printed Patient-specific Instrumentation (PSI). An RCT Comparing Correction Aimed at 62% Versus 55%.","Inclusion Criteria:\n\n* Patients having accepted and signed the informed consent form before surgery\n* Patients aged 30-60 years\n* Patients with an indication for primary HTO based on anamnestic, clinical and radiological findings leading to the diagnosis of major medial knee compartment overload symptoms\n* Mechanical varus axis of 3-9 deg. (calculated on full length weightbearing X-ray (FLWB))\n* Correctable angular deformity on the tibia only (medial proximal tibial angle (MPTA) + planned correction \\\u003C 95 deg. Lateral distal femoral angle (LDFA) \\\u003C92 deg.)\n* Maximal calculated gap height 14 mm\n* Only the first knee will be included if later contralateral HTO\n\nExclusion Criteria:\n\n* Inflammatory arthritis (Rheumatoid Arthritis, Bechterew arthritis, Psoriatic Arthritis)\n* Patients using Prednisolone perorally\n* Smokers (need to quit preoperatively)\n* Significant overweight (Body Mass Index \\> 35)\n* Earlier fractures in affected leg with fracture malalignment \\>5 deg.\n* Extension deficit \\>10 deg. in the affected knee\n* Earlier septic arthritis\u002Fosteomyelitis in the affected leg\n* Previous major surgery affecting leg function. Earlier knee arthroscopic procedures like ACL-reconstruction are not excluded\n* Planned combined procedures involving HTO + ACL\u002FPCL-reconstruction, meniscal transplantation or meniscal root fixation is excluded\n* Neurologic disease with symptoms affecting the leg\n* Serious illness or other factors that make communication, follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease, non-Norwegian speakers).",{"count":400,"type":20},70,[23],"The purpose of this RCT is to investigate whether high tibial osteotomy using 3D printed patient specific guides aiming at 55% correction is non-inferior to aiming at 62%.",[404,405,406],"Osteoarthritis, Knee","Knee Pain Chronic","Arthralgia",[408,409,410,411,412,413,414,415,416,417,418,419],"osteotomy","knee","osteoarthritis","3D print","PSI","High tibial osteotomy","Knee overload","Inertial measurement units","IMU","wearable sensors","gait analysis","accelerometer","2023-11-10",{"date":422,"type":39},"2023-11-18",{"date":424,"type":20},"2023-11",{"date":426,"type":20},"2028-10",{"name":45,"class":46},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":21,"phases":438,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":114},"100465706","phase-2-efficacy-and-safety-of-anti-pd-1pd-l1-treatment---uv1-vaccination-in-patients-with-non-small-cell-lung-cancer-100465706","NCT05344209","Efficacy and Safety of Anti-PD-1\u002FPD-L1 Treatment +\u002F- UV1 Vaccination in Patients With Non-small Cell Lung Cancer","A Randomized Phase II, Open-label, Multicenter Study Investigating Efficacy and Safety of Pembrolizumab +\u002F- UV1 Vaccination as First Line Treatment in Patients With Inoperable Advanced or Metastatic Non-small Cell Lung Cancer","LUNGVAC","Inclusion Criteria:\n\n* Histologically confirmed NSCLC stage IIIB\u002FIIIC or IV not amenable for curative treatment, with PD-L1 ≥ 50% measured by a validated method, and eligible for pembrolizumab monotherapy in the first-line setting\n* At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.1\n* Subjects who received previous neo-adjuvant or adjuvant systemic therapy (other than immunotherapies) will be eligible if neo-adjuvant or adjuvant therapy was completed at least 12 months prior to the development of metastatic disease. Last dose of neoadjuvant or adjuvant therapy must be more than 12 months prior to enrollment\u002Frandomization\n* Available unstained archived tumour tissue sample in sufficient quantity to allow for analyses. At least fifteen unstained slides or a tumour block (preferred)\n* Male and female age ≥ 18 years at time of signing the ICF\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ function as defined below\n* Haemoglobin ≥9.0 g\u002FdL\n* Absolute neutrophil count (ANC) 1.5 x (\\> 1500 per mm3)\n* Platelet count ≥100 x 109\u002FL (\\>75,000 per mm3)\n* Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).\n* AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n* Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL \\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\nMales:\n\nCreatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg\u002FdL)\n\nFemales:\n\nCreatinine CL (mL\u002Fmin)\n\n= Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n\n* Written informed consent obtained prior to any study specific procedure\n\nExclusion Criteria:\n\n* Previous treatment with a PD-1 or PD-L1 inhibitor, including pembrolizumab or any other agent targeting immune checkpoints\n* Previous malignancy (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry\n* Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and\u002For corticosteroids (prednisone \\>10 mg or equivalent). Surgery, radiation and\u002For corticosteroids (any dose \\>10 mg prednisone equivalent) must have been completed ≥ 2 weeks prior to registration\n* Known history of leptomeningeal carcinomatosis\n* Uncontrolled seizures.\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroid premedication given as prophylaxis for imaging contrast allergy should not be counted for this criterion\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome) within the past 2 years. Subjects with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded\n* History of primary immunodeficiency\n* History of allogeneic organ transplant\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent\n* Active infection including tuberculosis (clinical evaluation including: physical examination findings, radiographic findings, positive PPD test, etc.), hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result), hepatitis C, or human immunodeficiency virus (positive HIV 1\u002F2 antibodies as defined by a positive ELISA test). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. HIV testing is not required in the absence of clinical suspicion\n* Pregnant or lactating women\n* Live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving pembrolizumab\n* Any condition that, in the opinion of the investigator, would interfere with the evaluation of study treatment or interpretation of patient safety or study results\n* History of allergy or hypersensitivity to any of the active substances or excipients in the study drug\n* Involvement in the planning and\u002For conduct of the study (investigator staff and\u002For staff at the study site)\n* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements",{"count":437,"type":20},138,[439],"PHASE2","A Randomized, Multicenter Study Investigating Efficacy and Safety of anti-PD-1\u002FPD-L1-treatment +\u002F- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer. The objective of the phase 2 study is to induce a meaningful Progression-Free Survival (PFS) benefit in patients with stage IIIB\u002FIIIC or stage IV NSCLC by treating with anti-PD-1\u002FPD-L1 treatment and UV1 vaccination versus anti-PD-1\u002FPD-L1 treatment alone.",[442,443,444],"Oncology","NSCLC Stage IV","NSCLC, Stage III","2023-11-08",{"date":447,"type":39},"2023-11-09",{"date":449,"type":39},"2022-08-12",{"date":451,"type":20},"2027-07-01",{"name":45,"class":46},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":15,"minAge":200,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":4},"100524214","improved-diagnostics-treatment-and-follow-up-of-acute-exacerbation-of-chronic-obstructive-pulmonary-disease-100524214","NCT06105814","Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease","Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPEXNOR)","COPEXNOR","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admitted to the emergency room with a tentative diagnosis of AECOPD, and at least two of the following criteria, more than the daily variation,\n\n  * Increased dyspnea\n  * Increased cough\n  * Increased sputum production\n  * Need for change in medication due to AECOPD\n* Signed informed consent. Among patients with temporal or permanent reduced ability to consent, close relatives and\u002For family members must be asked and may approve or reject participation on behalf of the patient. In cases where close relatives\u002Ffamily members are not available, study personnel may include patients according to conscious judgment.\n* Patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel.\n\nExclusion Criteria:\n\n* Pulmonary embolism, segmental or larger\n* Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg\u002Fkg\u002Fmin noradrenaline or equivalent dose of other vasopressor(s)\n* Glasgow Coma Scale score 3\n* Patients not eligible for lower airways sampling within the first 24 hours of admission\n* Palliative situation with life expectancy \\\u003C 1 week",{"count":462,"type":20},200,[23],"Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD.\n\nCOPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.",[466,467,468],"Chronic Obstructive Pulmonary Disease Exacerbation","Pneumonia","Respiratory Tract Infections","2023-10-23",{"date":471,"type":39},"2023-10-30",{"date":473,"type":20},"2024-01-01",{"date":112,"type":20},{"name":45,"class":46},""]