[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sorlandet Hospital HF\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":328},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,50,87,119,148,174,211,242,264,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100639687","group-based-act-for-psychological-distress-of-young-people-100639687",false,"NCT07617467","Group-based ACT for Psychological Distress of Young People","ACT-YOUNG","Inclusion Criteria:\n\n* Score on DASS-21 depression scale ≤ 14\n\nExclusion Criteria:\n\n* Psychosis","ALL","16 Years","25 Years",{"count":20,"type":21},212,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical study investigates the effectiveness of two psychological treatment formats for young people aged 16-25 with symptoms of depression, anxiety, stress, or interpersonal difficulties. The study compares group-based Acceptance and Commitment Therapy (ACT) with treatment as usual (TAU), most frequent that would be individual psychotherapy, both of which are established treatment approaches.\n\nThe study uses a randomized controlled design (RCT), in which participants are randomly assigned to one of the two treatment conditions. This allows for a systematic comparison of treatment outcomes between ACT delivered in a group format and standard individual therapy.\n\nThe ACT group intervention consists of a structured program in which participants meet regularly over a defined treatment period. The treatment focuses on processes such as psychological flexibility, acceptance of internal experiences, and engagement in actions aligned with personal values.\n\nThe individual therapy condition consists of one-to-one sessions with a clinician, following standard therapeutic practice. Treatment content and duration are tailored to the participant's clinical presentation and therapeutic needs.\n\nOutcome measures include standardized assessments of mental health symptoms, functioning, and psychological processes. These assessments are conducted at baseline, during the treatment period, at post-treatment, and at follow-up time points. Data collected from these measures will be used to evaluate changes over time and differences between the two treatment conditions.\n\nThe primary aim of the study is to determine whether group-based ACT is as effective as, or more effective than, individual psychotherapy for young people receiving mental health services. The results are expected to contribute to improved knowledge about treatment options for this age group and inform future clinical practice.",[27,28,29,30],"Depression - Major Depressive Disorder","Depression Anxiety Disorder","Anxiety","Anxiety Depression",[32,33,34,35,36],"depression","Acceptance and Commitment Therapy","anxiety","anxiety depression","adolescents","RECRUITING","2026-05-22",{"date":40,"type":41},"2026-06-01","ACTUAL",{"date":43,"type":41},"2026-03-09",{"date":45,"type":21},"2028-12-31",{"name":47,"class":48},"Sorlandet Hospital HF","OTHER_GOV",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":49},"100640968","group-vs-individual-metacognitive-therapy-for-generalized-anxiety-disorder-100640968","NCT07579897","Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder","Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy","Inclusion Criteria:\n\nAdults with a primary diagnosis of generalized anxiety disorder (GAD). GAD-7 score ≥ 10 at screening\u002Fbaseline. Participants must endorse that they experience problems with excessive worry\n\nExclusion Criteria:\n\n1. Bipolar disorder;\n2. Psychosis;\n3. Ongoing substance abuse\u002Fdependence;\n4. Intellectual disability based on previous medical history;\n5. Eating disorder in need of medical attention;\n6. Unwillingness to refrain from anxiolytic drugs during the treatment;\n7. Current suicidal ideation with plan and intent;\n8. Taking an unstable dose of antidepressant, with recent dose-change within the last 4 weeks;\n9. Known cluster A or B personality disorder;\n10. Serious medical comorbidity (e.g.: cancer, severe renal failure)\n11. Language difficulties in need of an interpreter.","18 Years",{"count":59,"type":21},64,[24],"Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients.\n\nThis randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries.\n\nThe main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care.\n\nThis will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.",[63],"Generalized Anxiety Disorder",[63,65,29,66,67,68,69,70,71,72,73,74,75,76,77,78],"GAD","Metacognitive Therapy","MCT","Group Metacognitive Therapy","Individual Metacognitive Therapy","Worry","Psychotherapy","RCT","Randomized Controlled Trial","Anxiety Treatment","Group Therapy","Adult Mental Health","Cognitive Attentional Syndrome","CAS","2026-05-06",{"date":81,"type":41},"2026-05-12",{"date":83,"type":41},"2026-03-27",{"date":85,"type":21},"2028-12",{"name":47,"class":48},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":106,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100608750","the-good-pain-consultation-in-endometriosis-100608750","NCT07205614","The Good Pain Consultation in Endometriosis.","Inclusion Criteria:\n\n* biological women\n\nExclusion Criteria:\n\n* not speaking norwegian","FEMALE","50 Years",{"count":96,"type":21},110,[24],"This PhD project investigates the effect of \"the good pain consultation\" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources.\n\nOur research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.?\n\nResearchers will compare a good pain consultation to a control group that will receive usual care.\n\nParticipants will:\n\nAttend a consultation and biopsychososial pain education plus usual care or usual care alone.\n\nThey will answer questions in an internet-based questionnaires three times point during the study.",[100,101,102,103,104,105],"Pelvic Pain Syndrome","Endometriosis","Dysmenorrhea","Adenomyosis","Period Pain","Menstrual Pain",[107,108,109],"pain education","biopsychosocial","randomised controlled trial","2026-04-22",{"date":112,"type":41},"2026-04-28",{"date":114,"type":41},"2025-11-01",{"date":116,"type":21},"2028-06-01",{"name":47,"class":48},1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":136,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":118},"100624296","the-southern-norway-post-stroke-atrial-fibrillation-study-100624296","NCT07407790","The Southern-Norway Post-Stroke Atrial Fibrillation Study","SNAPS","Inclusion Criteria:\n\n* Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, occurring within the last 2 weeks.\n* Initial evaluation of CT and\u002For CT angiography and\u002For MRI supports a diagnosis of TIA or ischemic stroke.\n* Available smartphone and access to the ECG247-app to be able to participate in the study.\n* Estimated life span of \\>6 month\n* Permanent address in Norway\n* Informed Consent, Capable of giving signed informed consent or consent through proxy as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n* Known AF or atrial flutter prior to inclusion\n* Concomitant use of anticoagulation therapy or established contraindication to its use. To date this includes apixaban, rivaroxaban, edoxaban, dabigatran, warfarin and indirect thrombin inhibitors (except for short term thrombosis prevention).\n* Implanted pacemaker, ICD or loop-recorder\n* \\>70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound\n* Pregnancy",{"count":127,"type":21},450,[24],"This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Atrial fibrillation is a major cause of stroke, but it can be difficult to catch because it often comes and goes.\n\nThe study will include approximately 450 adults who have had a stroke or a transient \"mini-stroke\" (TIA) within the last two weeks. Participants will be assigned by chance (randomized) to one of two groups:\n\n* Group 1 (Intervention): Participants wear the \"ECG247 Smart Heart Sensor.\" This is a small patch that sticks to the chest and connects to a smartphone. It is worn continuously for up to 14 days, even after leaving the hospital.\n* Group 2 (Standard Care): Participants receive the standard hospital check-up. This typically involves using a \"Holter monitor\" (a device with wires and electrodes) for a period of about 24 to 48 hours some time after leaving the hospital.\n\nThe main goal is to see if the procedure using the patch is equal to the standard procedure in detecting atrial fibrillation in participants. The study will also measure how quickly doctors can start the correct medication and how easy the patients find the devices to use.",[131,132,133,134,135],"Atrial Fibrillation (AF)","Atrial Fibrillation (Prevention of Stroke)","Ischemic Stroke","Secondary Prevention","Arrhythmia Atrial",[137,138,139],"stroke","atrial fibrillation","anticoagulation","2026-02-05",{"date":142,"type":41},"2026-02-12",{"date":144,"type":41},"2026-01-10",{"date":146,"type":21},"2029-12",{"name":47,"class":48},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":118},"100591685","randomized-trial-comparing-fecal-testing-fit-to-colonoscopy-for-post-polypectomy-surveillance-100591685","NCT06983639","Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance","FIT Versus Colonoscopy for Post-polypectomy Surveillance","Inclusion Criteria:\n\n* High-quality baseline colonoscopy with adequat cleansing and cecal intubation\n* Remocval of at least one advanced adenoma\n* Clean colon (all polyps removed)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Colorectal cancer\n* History of surgical colon resection for any reason\n* Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)\n* ≥ 10 adenomas at baseline colonoscopy (cumulative)\n* History of advanced serrated lesion, defined as SSL≥ 10mm or with dysplasia\n* Inflammatory bowel disease\n* On-going palliative care for any reason","40 Years","75 Years",{"count":158,"type":21},4000,[24],"From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.",[162],"Colorectal Neoplasms",[164,165],"surveillance","polyp","2026-01-13",{"date":168,"type":41},"2026-01-15",{"date":170,"type":41},"2026-01-09",{"date":172,"type":21},"2050-01-01",{"name":47,"class":48},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":16,"minAge":182,"maxAge":57,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":194,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":49},"100608585","where-wild-things-grow-nature--and-activity-based-group-interventions-for-neurodivergent-children-and-youth-100608585","NCT07203469","Where Wild Things Grow: Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth","Where Wild Things Grow: Immediate and Long-term Impact of Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth in School, Health Care and Leisure Settings in Agder","Inclusion Criteria:\n\n* In PhD 1, participants are recruited on class-level (all) or individual (identified need).\n* In PhD 2, inclusion criteria are patients that participate in the specific interventions.\n\nExclusion Criteria:\n\n* In PhD 2, exclusion criteria include substance misuse, acute psychosis, current suicidal behavior\u002Fideation, and severe eating disorders.",true,"5 Years",{"count":184,"type":21},240,[24],"The goal of this action research project is to develop and implement nature- and activity-based group interventions across health care, school and leisure settings in Southern Norway. The interventions are tailored to support the mental health, self-efficacy and daily life functioning of children and youth in the Agder region, with a particular focus on youngsters who struggle due to neurodivergence, such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD) or Tourette's syndrome.\n\nThe main questions we aim to answer are:\n\n1. To what extent does nature- and activity-based outdoor education contribute to improvements in children's quality of life?\n2. To what extent does nature- and activity-based interventions in a health care setting improve children's self-efficacy, self-esteem and quality of life?\n3. Is there a difference in physiological reactions between nature-based provision of education or therapy and traditional indoor provision of education or therapy?\n\nParticipants will take part in a 12-week school-based or health care intervention.",[188,189,190,191,192,193],"Neurodevelopmental Outcomes","ADHD - Attention Deficit Disorder With Hyperactivity","Autism","Tourette Syndrome","Health-Related Quality-of-Life","Heart Rate Variability (HRV)",[195,196,197,198,190,199,200,201,202],"Nature-based","Action research","child and adolescent mental health","ADHD","Health-related quality of life","outdoor therapy","experiential education","heart rate variability","2025-10-01",{"date":205,"type":41},"2025-10-02",{"date":207,"type":41},"2025-09-01",{"date":209,"type":21},"2027-06-15",{"name":47,"class":48},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":219,"maxAge":57,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":118},"100492002","psychoeducation-of-parents-to-children-with-fasd-100492002","NCT05686473","Psychoeducation of Parents to Children With FASD","Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)","NorFASDPEdu","All children and adolescents (age 2,5-18 years) referred to the Regional Competence Centre for children with prenatal alcohol exposure in Arendal, Norway will be invited to participate in the current research project.\n\nInclusion criteria:\n\n* Valid information about alcohol exposure in fetal life. Exceptions to this inclusion criterion are children who have been adopted and with dysmorphic features that are consistent with full Fetal Alcohol Syndrome.\n\nExclusion Criteria:\n\n* Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).","2 Years",{"count":221,"type":21},75,[24],"By longitudinal, prospective research in children and adolescents with Fetal Alcohol Spectrum Disorders (FASD) and their parents to explore the beneficial effects of participating in a standardized intervention program in order to treat and reduce the consequences of early brain damage. By using elements from international programs based on psychoeducation and parent training, the investigators aim to help parents to better understand and respond to the neurodevelopmental disabilities of their children, and thereby improving behavioral problems and self-regulation deficits.",[225,226,227,228],"Fetal Alcohol Spectrum Disorders","Behavior Problem","Adaptive Behavior","Learning Disorders",[230,231,232,233],"FASD","Psychoeducation","Parenting","Information program","2025-05-16",{"date":236,"type":41},"2025-05-21",{"date":238,"type":41},"2025-05-01",{"date":240,"type":21},"2026-12",{"name":47,"class":48},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":249,"targetDuration":251,"studyType":252,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":118},"100544130","non-invasive-diagnostics-of-microbial-keratitis-100544130","NCT06364878","Non-invasive Diagnostics of Microbial Keratitis","New Non-invasive Cellular and Molecular Diagnostics of Microbial Keratitis","Inclusion Criteria:\n\n* Clinically suspected infectious keratitis in patients over 18 years of age\n* Patients with acceptable travel distance to the hospital\n* Patients accepting to be part of the study\n\nExclusion Criteria:\n\n* Previously diagnosed infectious keratitis during the last 6 months\n* Over 50 percent thinning of the cornea\n* Previous use of antibiotics (other than Chloramphenicol)",{"count":250,"type":21},125,"3 Months","OBSERVATIONAL","Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration.\n\nThis project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film.\n\nUsing in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics.\n\nThe project aims are translated into the following hypotheses:\n\nH1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results.\n\nH2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis.",[255],"Infectious Keratitis","2024-04-10",{"date":258,"type":41},"2024-04-15",{"date":260,"type":41},"2023-08-23",{"date":262,"type":21},"2028-04-08",{"name":47,"class":48},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":252,"phases":4,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":118},"100434811","establishing-mechanical-thrombectomy-at-a-limited-volume-stroke-center---effects-on-patient-morbidity-and-mortality-100434811","NCT04942041","Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality","Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.","Inclusion Criteria:\n\n* Adult patients\n* Large vessel occlusion stroke\n\nExclusion Criteria:\n\n* Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area\n* More than 24 hours after stroke onset","100 Years",{"count":273,"type":21},300,"The regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Therefore the implementation will be guided by a simulation based quality assurance program. In this study, we will monitor timelines, technical and clinical outcomes, including adverse events.",[276],"Stroke, Acute Ischemic",[278,279,280,281],"Stroke","Thrombectomy","Simulation","Quality program","2023-12-21",{"date":284,"type":41},"2023-12-29",{"date":286,"type":41},"2021-01-01",{"date":240,"type":21},{"name":47,"class":48},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":320,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":4},"100530148","phase-4-ivig-in-painful-sensory-neuropathy-100530148","NCT06183008","IVIG in Painful Sensory Neuropathy","Effect of Intravenous Immunoglobulins on Painful Sensory Neuropathy Evaluated by Aggregated N-of-one Trials","Inclusion Criteria:\n\nPainful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or sensory neuronopathy\n\n* Idiopathic small fiber neuropathy (all of the following)\n\n  1. Neuropathic pain (length-dependent\u002Fnon-length dependent\u002Ffocal) and at least two of the following clinical signs\n\n     1. Hypoesthesia (tactile, pinprick, or thermal)\n     2. Allodynia (tactile, dynamic, thermal, pressure)\n     3. Hyperalgesia\n     4. Aftersensation\n  2. Normal nerve conduction studies:\n  3. Reduced intra-epidermal nerve fiber density at the distal leg (IENFD) at the distal leg or Reduced thermal threshold assessed at the foot by QST\n  4. Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy\n* Sensory neuronopathy (all of the following)\n\n  1. Clinical pure sensory neuropathy\n  2. A score \\>6.5 on the following\n\n     1. Ataxia in the lower or upper limb: 3.1p\n     2. Asymmetrical distribution of sensory loss: 1.7p IVIGSeN Protocol number 1.2\n     3. Sensory loss not restricted to the lower limb at full development: 2.0 p\n     4. At least 1 sensory action potential absent or 3 sensory action potentials \\\u003C30% of the lower limit of normal in the upper limbs not explained by entrapment neuropathy: 2.8p\n     5. Less than two nerves with abnormal motor nerve conduction studies in the lower limbs: 3.1p\n  3. Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy\n\nPain intensity \\> 5.0 on a pain score from 0-10, lasting at least 4 weeks\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Previous allergic reaction to IVIG or other blood products)\n2. Selective IgA deficiency\n3. Cardiac insufficiency (NYHA III\u002FIV ie marked or severe limitation in activity due to symptoms, even during less-than-ordinary activity)\n4. Cardiac dysrhythmia requiring treatment\n5. Unstable or advanced ischemic heart disease\n6. Severe hypertension (diastolic \\>120 or systolic \\> 170)\n7. Known hyperviscosity\n8. Renal insufficiency (GFR \\\u003C 30 ml\u002Fmin\u002F1,73m2) or nephrotic syndrome\n9. Previous thromboembolic event\n10. Smoking\n11. Diabetes\n12. Prolonged immobilization\n13. Hypercoagulable state\n\n    Prior\u002FConcomitant Therapy\n14. Change of pain medication in the 30 days prior to inclusion (unchanged pain medication is allowed, provided dosages stay equal during the study)\n15. Treatment with IVIG the last 4 weeks or other ongoing immunomodulatory treatments\n16. Use of loop diuretics, Dinutuksimab beta, or Imlifidase Diagnostic assessments\n17. Predominant clinical or neurographic features of motor nerve fiber involvement Other Exclusions\n18. Females who are breastfeeding, pregnant or unwilling to practice contraception throughout the study\n19. Unable to give independent informed consent","65 Years",{"count":298,"type":21},20,[300],"PHASE4","The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.",[303,304],"Sensory Neuropathy","Small Fiber Neuropathy",[306,307,308,309,310,311,312,313,314,315,316,317,318,319],"nervous system diseases","neuromuscular diseases","peripheral nervous system diseases","small fiber neuropathy","sensory neuronopathy","sensory neuropathy","IVIG","Intravenous immunoglobulin","n-of-1","Sørlandet sykehus","Sorlandet hospital","Kristiansand","polyneuropathy","Intravenous immune globulin","NOT_YET_RECRUITING","2023-12-13",{"date":323,"type":41},"2023-12-27",{"date":325,"type":21},"2024-02",{"date":85,"type":21},{"name":47,"class":48},""]