[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patient-reported-outcome-measure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patient-reported-outcome-measure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100552674","safer-personalised-cancer-treatment-digital-follow-up-100552674",false,"NCT06476158","Safer Personalised Cancer Treatment Digital Follow-up","Monitoring of Adverse Events Caused by Systemic Cancer Treatment. Identifying Adverse Events Related to Immunotherapy Treatment Before and After Implementation of Personalized Digital Patient Reported Outcomes","SPecT","Inclusion Criteria:\n\n* Above 18 years of age\n* Cancer diagnosis as primary or secondary diagnosis according to the ICD-10 classification\n* Receiving immunotherapy as systemic anticancer treatment reported with ATC codes for medications.\n\nExclusion Criteria:\n\n* Hematological cancer\n* Gynecological cancer","ALL","18 Years",{"count":20,"type":21},900,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to investigate patient harm\u002F adverse events, overall survival and health related quality of life under treatment with immunotherapy medication in cancer patients when they are followed up by a personalized digital program where the patients report symptoms directly to health care personnel.\n\nThe main questions the clinical trial aims to answer are:\n\n* How often and how severe are immunotherapy related adverse events\u002F side effects when patients are followed up by a digital personalized patient-reporting system compared to standard follow-up?\n* How are life quality and survival affected for patients followed up by a digital personalized patient-reporting system compared to follow-up standard follow-up??\n\nParticipants under immunotherapy cancer treatment will be followed up by a digital patient reporting program in one group, and compared to a group of cancer patients receiving the same treatment, but with standard follow-up without a digital program in another group. Researchers will compare the two groups to see if there any differences in how many patients who develop immunotherapy related patient harm and how long the patients live.",[27],"Patient Reported Outcome Measure",[29,30,31,32,33],"Adverse events","Patient reported outcome","Digital follow-up","Immunotherapy","Routine cancer care","RECRUITING","2024-06-20",{"date":37,"type":38},"2024-06-26","ACTUAL",{"date":40,"type":38},"2024-06-01",{"date":42,"type":21},"2027-12-31",{"name":44,"class":45},"Nordlandssykehuset HF","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":46},"100471041","weber-b-ankle-fractures-with-associated-posterior-malleolus-fracture-100471041","NCT05413707","Weber B Ankle Fractures With Associated Posterior Malleolus Fracture","Posterior Malleolus Fractures (PMF) in Weber B Ankle Fractures - Fixation Versus no Fixation - a Randomized Controlled Trial","PMFIX","Inclusion Criteria:\n\n* Posterior malleolar (PM) fracture, of Mason \\& Molly type 2A\u002F2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture\n* Posterior malleoli \\>=2 mm displaced (on CT in axial, sagital or coronal plane)\n* Patients informed, written consent\n* Age 18-65 years\n* For inclusion axial CT images are examined\n\n  * Measurements are performed 5 millimeters (mm) cranial to the tibia plafond\n  * Posterior malleolus fractures involving less than 40% of the fibular notch are included.\n\nExclusion Criteria:\n\n* Non-compliant patient, i.e.: dementia, alcohol- or substance abuse\n* ASA-4 patients\n* Known congenital bone decease\n* Pathological fractures\n* Immunocompromised patients\n* Tourists or patients on a short-term work\u002Fstudy permit\n* Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction\n* Poor controlled diabetes\n* Patients with known arterial insufficiency\n* Open fractures\n* Severely traumatized patients (ISS\\>16)\n* Patient declines to participate in study","65 Years",{"count":57,"type":21},198,[24],"Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF.\n\nThrough a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients.\n\nMason and Molly type 2A and 2B fractures will be included in the study.",[61,62,63,27,64],"Posterior Malleolus Fractures","Ankle Fractures","Syndesmotic Injuries","Treatment Outcome",[66,67,68,69,70,71],"Posterior malleolus fractures","Ankle factures","Weber B fractures","Syndesmotic injuries","Fixation","Randomized Controlled Trial","2024-02-27",{"date":74,"type":38},"2024-02-29",{"date":76,"type":38},"2023-03-13",{"date":78,"type":21},"2030-12-31",{"name":80,"class":45},"Haukeland University Hospital"]