[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Haukeland University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":700},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,57,82,113,141,169,201,229,256,280,308,333,357,392,412,440,468,493,519,546,568,591,619,651,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":41,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100638424","ecardiacrehab---a-hybrid-patient-centered-ehealth-programme-100638424",false,"NCT07590635","eCardiacRehab - a Hybrid Patient-Centered eHealth Programme","eCardiacRehab - a Randomized Controlled Trial on a Hybrid Home-Based Patient-Centered eHealth Programme With Tailored Solutions","eCardiacRehab","Inclusion Criteria:\n\n* Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number\n* With coronary artery disease after percutaneous coronary intervention\n* Living at home\n* Have internet available\n* Provide signed informed consent\n\nExclusion Criteria:\n\n* Patients with cognitive impairment that may interfere with the ability to comply with the study protocol\n* Severe aortic stenosis\n* Severe arrhythmias\n* Expected lifetime less than one year as determined by study personnel\n* Otherwise clinically unstable\n* Not fully revascularized\n* Awaits percutaneous coronary intervention or coronary artery bypass graft surgery\n* Inability to comply with the study protocol due to any physical disability, somatic disease, or mental problems as determined by study personnel","ALL","18 Years",{"count":21,"type":22},1000,"ESTIMATED","INTERVENTIONAL",[25],"NA","The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all.\n\neCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (\\>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.",[28,29,30,31,32,33,34,35,36,37,38,39,40],"Comorbidities and Coexisting Conditions","Ethics","Continuity of Patient Care","Older Adults (65 Years and Older)","Cost-Benefit Analysis","Adherence, Medication","Secondary Prevention of Coronary Heart Disease","Health Literacy","eHealth Literacy","Mental Health","Cardiac Rehabilitation","Womens's Health","Coronary Artery Disease (CAD)",[38,42,43],"Coronary Artery Disease","Percutaneous Coronary Intervention","RECRUITING","2026-06-18",{"date":47,"type":48},"2026-06-23","ACTUAL",{"date":50,"type":48},"2026-05-21",{"date":52,"type":22},"2037-12-31",{"name":54,"class":55},"Haukeland University Hospital","OTHER",1,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":56},"100641049","effect-of-a-liberal-fasting-regime-sip-til-send-on-preoperative-gastric-volume-measured-using-point-of-care-ultrasound-100641049","NCT07656649","Effect of a Liberal Fasting Regime (Sip-til-Send) on Preoperative Gastric Volume Measured Using Point of Care Ultrasound","Inclusion Criteria:\n\n* Able to give written consent\n* Adult patient (\\> 18 years of age)\n* Planned general anaesthesia or deep sedation\n* Fasted for at least six hours for food and two hours for clear fluids upon arrival\n* Expected to wait at least one hour before surgery\n\nExclusion Criteria:\n\n* Unable to give written consent\n* Active gastrointestinal obstruction\n* Pregnancy\n* Ongoing opioid use\n* Previous stomach surgery - gastric banding \u002F Roux-en-Y \u002F sleeve gastrectomy\n* Use of GLP-1 agonist (Wegovy)\n* Type 1 or 2 diabetes",true,{"count":65,"type":22},120,"OBSERVATIONAL","Pulmonary aspiration of gastric contents during surgery is a rare but potentially catastrophic event. Current guidelines recommend that patients should fast for six hours for solid food and two hours for clear liquids. Despite this, many patients fast considerably longer than two hours for clear liquids, often as a result of logistical challenges.\n\nIn response to this, the Sip-to-Send concept was developed where patients are permitted to drink small amounts of clear liquid (170-200 ml per hour) until they are called to the operating department. The introduction of Sip-to-Send has been well received by patients and has been associated with increased patient satisfaction.\n\nFor planned general anaesthesia in the operating department, the incidence of pulmonary aspiration is estimated at approximately 1 per 4,500 anaesthetics. Because of this low incidence, it is in practice unrealistic to design studies using aspiration as the primary endpoint to demonstrate non-inferiority of new fasting regimens. For example, a study with a non-inferiority margin of 20%, power of 90% and a one-sided α of 0.025, based on an incidence of 1 per 4,500, would require approximately 2.6 million patients in each study arm.\n\nGastric ultrasound represents a rapid, non-invasive technique for estimating gastric volume by measuring the cross-sectional area of the antrum and subsequently calculating volume. Several studies have shown that cross-sectional area correlates reliably with gastric volume, with good inter- and intra-observer reliability.\n\nSip-to-Send has been established practice at the Day Surgery Department at Haukeland since October 2023. The purpose of this study is to investigate whether there is a clinically relevant change in gastric volume as a result of this liberal fasting regimen.",[69],"Fasting Status",[71,72,73,74],"gastric ultrasound","liberal fasting","elective surgery","sip-til-send","2026-06-15",{"date":45,"type":48},{"date":78,"type":48},"2026-06-02",{"date":80,"type":22},"2027-08-15",{"name":54,"class":55},{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100616937","phase-2-d-spark-a-clinical-trial-of-d-serine-for-modifying-parkinsons-disease-progression-100616937","NCT07312110","D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression","D-SPARK: A Randomized Double Blind Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression","D-SPARK","Inclusion Criteria:\n\n* A clinical diagnosis of PD\\* according to the clinically established MDS clinical diagnostic criteria for Parkinson's disease within 5 years.\n* \\[¹²³I\\]FP-CIT single photon emission CT (DaTscan) confirming dopaminergic nigrostriatal denervation.\n* Hoehn and Yahr score \\\u003C 3 at enrollment.\n* Optimal symptomatic PD treatment, not requiring adjustments, for at least 2 weeks.\n* Age ≥40 and ≤ 80 years at time of enrollment.\n\nExclusion Criteria:\n\n* Dementia or neurodegenerative disorder other than PD at baseline visit.\n* Atypical parkinsonism (PSP, MSA, CBD vascular parkinsonism, or drug induced parkinsonism).\n* Any known monogenic cause of PD (GBA1 variation is accepted).\n* Any psychiatric disorder that would interfere with compliance in the study.\n* Any severe somatic illness that would make the individual unable to comply and participate in the study.\n* Use of D-serine supplementation within 90 days of enrolment.\n* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.\n* Active of planned pregnancy during trial period.\n* Cognitive impairment as measured by the Mini Mental Status Exam MMSE) \\\u003C 20.\n* Weight \\\u003C 45 kg.\n* Urinary albumin\u002Fcreatinine ratio ≥ 20 mg\u002Fmmol at time of enrollment.\n* Participants will be excluded if they have CKD stage 3 or higher, defined as:\n\n  * Estimated golumerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73min\\^2 at screening, calculated using the CKD-EPI 2021 creatinine equation.","40 Years","80 Years",{"count":93,"type":22},100,[95],"PHASE2","This clinical study, designed as a randomized, double-blind, placebo-controlled trial, aims to investigate if modulation of the N-methyl-D-aspartate receptor (NMDAR) via its co-agonist D-serine has therapeutic benefits in Parkinson's disease (PD). All patients will receive both placebo and D-serine over different time periods during the study.\n\nPreclinical studies have shown that blocking glycine transporters, which elevates endogenous glycine levels, can restore NMDAR function and improve motor deficits in PD models. A clinical trial demonstrated that oral D-serine (30 mg\u002Fkg\u002Fday for 6 weeks) significantly reduced extrapyramidal and abnormal involuntary movements in PD patients compared to placebo, with improvements observed in both motor and non-motor symptoms. D-serine supplementation has shown an acceptable safety profile with doses up to 120 mg\u002Fkg showing no significant adverse effects in clinical studies.\n\nThe D-SPARK trial primarily aims to determine the efficacy of D-serine supplementation on clinical severity of PD as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).\n\nSecondary aims are to determine the efficacy of D-serine supplementation on improving dopaminergic nigrostriatal innervation as measured by single-photon emission tomography (SPECT) based imaging of the dopamine transporter (DaT-scan) and cognition as measured by the California Verbal Learning Test version 2 (CLVT-II).\n\nThe study will include 100 persons with Parkinson's disease (PwPD) diagnosed no longer than 5 years before baseline. Participants will be randomly assigned to receive D-Serine 4000 mg daily or placebo for defined periods of time during a 58 week treatment period, followed by a 12 week washout period.\n\nParticipants will undergo:\n\n* Clinical evaluations, including clinical rating scales and questionnaires.\n* Cognitive assessments.\n* Bio sampling of whole blood and blood plasma.\n* Single-photon emission tomography (SPECT) imaging of dopamine transporter levels (DaT-scan)\n\nThe outcomes of this study could potentially demonstrate that D-serine reduces symptom severity in Parkinson's disease and\u002For has an impact on the clinical trajectory of Parkinson's disease, benefiting persons living with Parkinson's disease, their families and society as a whole.",[98,99],"Parkinson s Disease","Parkinson Disease (PD)",[101,102,103],"Serine","Parkinsons disease","D-serine","2026-06-03",{"date":106,"type":48},"2026-06-04",{"date":108,"type":48},"2026-01-20",{"date":110,"type":22},"2028-12",{"name":54,"class":55},11,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":91,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":56},"100467540","endoscopic-ultrasound-guided-radiofrequency-ablation-in-primary-aldosteronism-100467540","NCT05368090","Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism","Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism","Inclusion Criteria all groups\n\n* Signed written informed consent\n* If CT scan shows an adrenal nodule to the same adrenal as AVS lateralisation result: nodule size \\\u003C 4 cm and enhancement criteria for adrenal adenoma (native hounsfield units \\\u003C 10 or relative wash-out \\> 40% or absolute wash-out \\> 60%)\n\nPA unilateral group inclusion criteria:\n\n* Age 18 to 60 years\n* PA diagnosis confirmed according to Endocrine Society PA Guideline criteria\n* AVS lateralisation to left adrenal (lateralisation index ≥ 4,0)\n\nPA \"debulking\" group inclusion criteria:\n\n* Age 18 to 70 years\n* PA diagnosis confirmed according to Endocrine Society PA Guideline criteria\n\nMACS unilateral and debulking group inclusion criteria:\n\n* Age 18 to 80 years\n* MACS diagnosis confirmed according to ENSAT\u002FECE Guideline criteria\n* AVS lateralisation to the left adrenal, and visible left adrenal tumor on CT scan OR bilateral overproduction of cortisol on AVS, and bilateral tumors\u002Fhyperplasia on CT scan (debulking)\n\nExclusion Criteria all groups:\n\n* CT scan suspicion of adrenal malignancy\n* Patient refusal to undergo either EUS-RFA or adrenalectomy",{"count":121,"type":22},60,[25],"In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural safety will be evaluated. In study patients with verified lateralised aldosterone or cortisol overproduction to the left adrenal, outcome will be compared with control groups performing conventional unilateral adrenalectomy.\n\nStudy group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment.\n\nStudy group 2: PA patient with suspected left-sided overweight of aldosterone production and a EUS-detectable tumour but without strict lateralisation of their aldosterone overproduction, for EUS-RFA treatment as an aldosterone \"debulking\" procedure.\n\nStudy group 3: patients with MACS with AVS-verified lateralisation of cortisol overproduction to the left adrenal and EUS-detectable tumour for EUS-RFA treatment Study group 4: patients with MACS with bilateral adrenal tumours and verified bilateral overproduction of cortisol for EUS-RFA treatment as a cortisol \"debulking\" procedure.",[125,126,127],"Primary Aldosteronism","Aldosterone-Producing Adenoma","Hypercortisolism",[129,130,131,132],"radio frequency ablation","postoperative hypoaldosteronism","postoperative hypocortisolism","metabolic comorbidity","2026-05-07",{"date":135,"type":48},"2026-05-08",{"date":137,"type":48},"2022-06-03",{"date":139,"type":22},"2028-12-31",{"name":54,"class":55},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":149,"minAge":19,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":167,"locationsCount":168},"100640622","phase-1-reestablishing-normal-gut-brain-interaction-in-anorexia-nervose-with-normal-gut-microbiota-100640622","NCT07574892","Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota","Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart","Restart","Inclusion Criteria:\n\nAge 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt\n\nExclusion Criteria:\n\nAge below 18 years BMI below 16 kg\u002Fm2 Significant electrolyte disturbances Other signs of medical instability Presence of systemic disease, Immune deficiency Treated with immune-modulating medication Pregnancy Planning pregnancy Lactations Having undergone abdominal surgery (with the exception of appendectomy, cholecystectomy, caesarian section and hysterectomy) severe psychiatric disease (except anorexia nervosa) Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry.","FEMALE",{"count":151,"type":22},36,[153],"PHASE1","In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.",[156],"Anorexia Nervosa",[158,159,160],"Anorexia nervosa","Fecal microbiota transplantation","Psychotherapy","NOT_YET_RECRUITING","2026-05-05",{"date":135,"type":48},{"date":165,"type":22},"2026-06-01",{"date":110,"type":22},{"name":54,"class":55},4,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":200,"locationsCount":112},"100562864","the-key-to-integrated-trauma-treatment-in-psychosis-trial-100562864","NCT06608706","The Key to Integrated Trauma Treatment in Psychosis Trial","The Key to Integrated Trauma Treatment in Psychosis (Kit) Trial: A Pragmatic, Multicenter Effectiveness RCT of EMDR for Trauma Symptoms in Schizophrenia Spectrum Disorders","KIT","Inclusion Criteria:\n\n1. aged ≥ 16 years\n2. diagnosis of F20-29 in the ICD-10 assessed using SCID 5 CV\n3. reporting trauma \\> 1 month prior to assessment\n4. being currently distressed by the reported trauma(s), i.e., ≥ 5 (from 0 = not at all, to 10 = extremely) on item 21c on the Trauma and Life Events Checklist (TALE)\n5. able and motivated for engaging in trauma focused (TF) therapy\n6. able to understand and give informed consent; consent capacity for psychological treatment choices and consent to study procedures.\n\nExclusion Criteria:\n\n1. primary diagnosis of substance use\u002Falcohol dependence\n2. inability to understand spoken Norwegian\n3. organic psychosis or a neurological disorder\n4. acute state of psychosis defined as:\n\n   1. hospitalized in an acute ward the last 6 weeks or\n   2. major change in antipsychotic medication type or started\u002Fstopped antipsychotic medication last 6 weeks or\n   3. other mental health crises last 6 weeks\n5. current or previous (past 6 months) TF therapy","16 Years",{"count":179,"type":22},187,[25],"Schizophrenia spectrum disorders (SSDs) have a significant trauma etiology: trauma has been reported in 65 - 80% in this patient group and have a negative impact on prognosis. Trauma treatment is currently not offered in SSDs due to a lack of evidence. KIT is a pragmatic trial comparing the effectiveness of added trauma focused therapy, Eye Movement Desensitization and Reprocessing (EMDR) to standard treatment in SSDs.\n\nThe study will compare EMDR as add on to treatment as usual (TAU) to TAU in patients with schizophrenia spectrum disorders (SSDs). The overall aim is to examine the effectiveness of EMDR on trauma symptoms in SSDs.\n\nParticipants will receive max. 26 sessions of EMDR, and complete assessments before, during and after the course of therapy, in addition to a period of time (6 months) after therapy to examine long-term effects.",[183,184,185],"Psychiatric Diagnosis","Schizophrenia Disorders","Psychological Trauma, Historical",[187,188,189,190,191,192,193],"Psychosis","EMDR","Trauma treatment","Schizophrenia spectrum disorders","Childhood trauma","Psychological trauma","PTSD","2026-04-21",{"date":196,"type":48},"2026-04-24",{"date":198,"type":48},"2024-09-01",{"date":139,"type":22},{"name":54,"class":55},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100496888","enabling-parents-of-children-with-autism-spectrum-disorders---a-randomized-controlled-trial-of-parenting-programs-100496888","NCT05750095","Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs","ENACT","Inclusion Criteria:\n\n* Parent of child diagnosed with an autism spectrum disorder, age 2-6\n\nExclusion Criteria:\n\n* Level of Norwegian insufficient to benefit from a parental program without the use of an interpreter\n* Ongoing major crisis in the family or major disabling condition in the participating parent\n* Ongoing participation in another manualized (any) parent program","2 Years","6 Years",{"count":211,"type":22},240,[25],"Autism spectrum disorders (ASD) are disabling and impairing conditions affecting 1% of children in Norway. ASD is hallmarked by severe social deficit and lack of independence causing reliance on supportive systems throughout life. Parents are usually the primary caretakers and support, often throughout life. Normal parenting skills are however often ineffective due to the social dysfunction of the child with ASD. This causes high stress as the demands exceed the resources and capability of the parent. The high stress is associated to increased risk for mental health problems, divorce, unemployment and reduced quality of life. High parent stress may also reduce the effect of interventions in ASD. However, although the need is great and parental follow-up is an integral part of health care for ASD children, there is a lack of evidence for such interventions.\n\nThe current project aims to evaluate a specific parent program that is in clinical use - the Incredible Years for children with ASD - compared with a standardised treatment as usual (TAU) composed of clinical parent workshops (\"first aid for parents\").\n\nThe aim is to evaluate parenting interventions and promote evidence-based practice in a clinical setting. The investigators will perform a randomized controlled trial and qualitative interviews to compare the effectiveness of treatment as usual (TAU) versus a manualized parent program (IY-ASLD). The study aims to investigate if the parental program may reduce parent stress and improve parental competence and self-efficacy. Secondary goals are to investigate whether the parent program may improve quality of life for the parent and the child and have an impact on long-term child functioning and service use.",[215],"Autism Spectrum Disorder",[217,218,219],"Stress","Parenting","Autism","2026-03-16",{"date":222,"type":48},"2026-03-18",{"date":224,"type":48},"2022-01-10",{"date":226,"type":22},"2028-10-30",{"name":54,"class":55},3,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":56},"100591785","a-handheld-tool-for-active-distraction-of-children-and-adolescents-during-painful-procedures-100591785","NCT06984939","A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures","Use of a Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures","Inclusion Criteria:\n\n* Written consent has been obtained from the parents or legal guardians.\n* Age 8-15 years old\n\nOne of the following:\n\n1. Attend the Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion\n2. Attend the Helsebanken in Øystese for blood sampling\n3. Attend TKVestland for planned dental treatment involving local anesthesia administered via injection (needle)\n4. Admitted to the Child and Youth Clinic at Haukeland University Hospital for the first time due to type 1 diabetes mellitus, requiring frequent blood glucose measurements and insulin injections.\n\nExclusion Criteria:\n\n* Moderate to severe intellectual disability\n* Impaired vision or hearing\n* Does not understand the Norwegian language\n* General condition affected by illness\n* Anticipated use of sedation during the procedure (e.g., Midazolam)\n* Previous participation in this study","8 Years","15 Years",{"count":239,"type":22},126,[25],"The goal of this clinical trial is to learn if the handheld device Grasp, works to reduce pain and distress during small procedures involving a needle prick in children and adolescents. The main question it aims to answer is:\n\nDoes repetitive squeezing of the Grasp device during the painful procedure affect self-reported pain and distress?\n\nResearchers will compare using the Grasp device during procedures where children and adolescent are having a needle prick (venous puncture, insertion of a peripheral venous catheter, local anesthetic injection before dental treatment) with standard care, to see if Grasp works to reduce pain and distress.\n\nParticipants will:\n\n* Use Grasp or standard care during procedures involving a needle prick\n* Report pain and distress on a paper form before and after the procedure",[243],"Pain",[245,246,247],"Active distraction","Procedural pain","Pediatrics","2026-03-04",{"date":250,"type":48},"2026-03-06",{"date":252,"type":48},"2025-05-27",{"date":254,"type":22},"2026-05-01",{"name":54,"class":55},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":56},"100623135","the-intravenous-amino-acid-therapy-for-vascular-rigidity-in-end-stage-renal-disease-100623135","NCT07392697","The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease","NASCAR","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of end-stage renal disease (ESRD) and undergoing maintenance hemodialysis (HD) or online hemodiafiltration (HDF).\n* On a stable dialysis regimen for a minimum of 90 consecutive days prior to enrollment.\n* Serum albumin level ≥30 g\u002FL.\n* Documented dialysis adequacy: single-pool Kt\u002FV (spKt\u002FV) \\> 1.2.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Administration of parenteral amino acids or intravenous nutrition within the past 90 days.\n* Severe hypertension (e.g., SBP \\>180 mmHg despite antihypertensive therapy).\n* Advanced liver disease classified as Child-Pugh class C.\n* Diagnosis of active malignancy or cancer treatment within the last 5 years.\n* Current participation in another interventional study or within the past 30 days.\n* Pregnant or breastfeeding women.\n* Psychiatric or cognitive impairment that interferes with informed consent or study compliance.\n* Life expectancy \\\u003C12 months due to unrelated comorbidities.",{"count":65,"type":22},[25],"The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure. Patients on dialysis often have problems with stiff blood vessels, which increases their risk of heart attacks, strokes, and other cardiovascular diseases. A chemical change called carbamylation is thought to make blood vessels age and stiffen faster. Amino acids may block this process and improve blood vessel health.\n\nThe main questions are:\n\n* Does amino acid treatment reduce the risk of death in dialysis patients?\n* Does it improve the health of the heart and blood vessels?\n* What side effects or medical problems happen when patients receive amino acids during dialysis?\n\nIn this study:\n\n* Participants will be randomly assigned to receive either amino acids (Synthamin 9®) or a placebo (saline).\n* The infusion (250 ml) will be given twice a week during dialysis sessions for 12 months.\n* After 12 months of treatment, patients will be followed for another 6 months.\n\nDuring the study, patients will:\n\n* Have regular blood tests to measure markers of blood vessel health, inflammation, and protein carbamylation.\n* Undergo heart and vessel tests, including echocardiography, CT scans, and pulse wave velocity measurements.\n* Complete quality-of-life questionnaires about symptoms and daily living.\n\nBy comparing the amino acid group with the placebo group, researchers will see whether amino acid therapy can make dialysis patients live longer and have healthier hearts and blood vessels.",[267,268],"Chronic Kidney Disease Requiring Chronic Dialysis","Cardiovascular Calcification",[270,271],"carbamylation","chronic kidney disease","2026-01-29",{"date":274,"type":48},"2026-02-06",{"date":276,"type":22},"2026-02-01",{"date":278,"type":22},"2028-11-01",{"name":54,"class":55},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":287,"maxAge":19,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":296,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":56},"100540302","dialectical-behavior-therapy-for-adolescents-with-self-harm-and-suicidal-behavior--an-open-trial-100540302","NCT06315075","Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial","Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open","Inclusion Criteria:\n\n* Age 13-18 years\n* Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)\n* Fluency in Norwegian\n* One parent\u002Ftrusted adult that can participate together with the adolescent.\n\nExclusion Criteria:\n\n* Intellectual disability\n* Significant learning or language impairments\n* Autism spectrum disorder\n* Anorexia Nervosa\n* Any psychotic disorder\n* Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.","13 Years",{"count":289,"type":22},140,[25],"The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:\n\n* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.\n* to investigate how well DBT-A works at 12 months follow-up\n* to investigate whether pre-treatment factors can predict who will benefit from treatment",[293,294,295],"Self-harm","Suicidal Ideation","Suicide and Self-harm",[295,297,298,299,300],"Adolescents","Dialectical behavior therapy for adolescents","Routine clinical practice","Effectiveness study",{"date":302,"type":48},"2026-01-22",{"date":304,"type":48},"2024-01-15",{"date":306,"type":22},"2029-12-31",{"name":54,"class":55},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100621083","the-norcup-trial-improving-prognosis-and-personalized-treatment-in-cancer-of-unknown-primary-cup-100621083","NCT07366008","The NorCUP Trial: Improving Prognosis and Personalized Treatment in Cancer of Unknown Primary (CUP)","NorCUP","Inclusion Criteria:\n\n* ECOG PS 0-2.\n* Life expectancy minimum 3 months.\n* Radiologically verified metastatic disease (CT thorax\u002Fabdomen\u002Fpelvis) with no radiological signs of primary tumor.\n* Histologically verified metastatic disease of unknown primary. Morphological and immunohistochemical findings suggesting a possible, but not definitive, origo is eligible.\n* Eligible histologies include adenocarcinoma, squamous cell carcinoma, poorly and undifferentiated carcinoma and undifferentiated neoplasms.\n* Clinically relevant endoscopic examinations have been performed as indicated by clinical, radiological and pathological findings, without identification of a primary tumor.\n* Clinically relevant supplementary radiological examinations have been performed as indicated by clinical, radiological and pathological findings, with no radiological signs of primary tumor (e.g. PET\u002FCT, mammography\u002FMR mammae).\n* Metastatic lesion available for biopsy. Protocol deviation may be allowed if lesion is not technically available for biopsy. For patients with metastatic lesion technically available for biopsy, the patient must be deemed medically fit to undergo a metastatic biopsy, as assessed by the investigator.\n* Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Patients with any clinically significant medical or psychiatric condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements.\n* Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.",{"count":316,"type":22},350,[25],"The goal of this clinical trial is to improve diagnosis and treatment strategies for patients with Cancer of Unknown Primary (CUP) by using advanced molecular profiling to identify the likely tumor origin and guide therapy.\n\nThe main questions it aims to answer are:\n\nCan comprehensive molecular profiling help determine the origin of CUP tumors? Does identifying the tumor origin improve treatment choices and survival outcomes compared to historical data?\n\nParticipants will:\n\n* Undergo a new biopsy to collect tumor tissue for advanced analyses.\n* Provide blood samples for circulating tumor DNA (cfDNA\u002FctDNA) analyses.\n* Provide a fecal sample for microbiome analysis.\n* Have their tumor tissue analyzed using:\n\nMethylation profiling and comprehensive gene panel testing.\n\n* Have the results reviewed in a specialized CUP molecular MDT meeting to determine the likely tumor origin and guide treatment.\n* Have their tumor tissue samples biobanked for further exploratory whole genome sequencing (WGS) and RNA sequencing.",[320],"Cancer of Unknown Primary Site",[322,323],"cancer of unknown primary site","neoplasms, unknown primary","2026-01-16",{"date":326,"type":48},"2026-01-26",{"date":328,"type":22},"2026-01",{"date":330,"type":22},"2033-01",{"name":54,"class":55},6,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":177,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":56},"100540213","exercise-therapy-in-mental-disorders-study-100540213","NCT06313918","Exercise Therapy in Mental Disorders-study","Inclusion Criteria:\n\n* ICD-10 schizophrenia-spectrum disorder (F2)\n* ICD-10 bipolar disorder (F3)\n* Capacity to provide informed consent.\n\nExclusion Criteria:\n\n* Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications\n* Life threatening or terminal medical conditions\n* Not able to carry out intervention or test procedures\n* Current pregnancy\n* Mothers less than 6 months post-partum.",{"count":340,"type":22},50,[25],"The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective.",[344,345],"Schizophrenia and Related Disorders","Bipolar Disorder",[347,348],"Exercise therapy","Effectiveness","2025-12-22",{"date":351,"type":48},"2025-12-30",{"date":353,"type":48},"2023-09-27",{"date":355,"type":22},"2026-09-26",{"name":54,"class":55},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":18,"minAge":177,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":379,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":56},"100613601","assess-the-efficacy-of-tailored-patient-information-and-voluntary-patient-managed-outpatient-digital-follow-up-i-pod-as-an-adjunct-to-standard-treatment-according-to-national-guidelines-in-the-national-trauma-plan-among-adult-trauma-patients-in-norway-100613601","NCT07268716","Assess the Efficacy of Tailored Patient Information and Voluntary Patient-managed Outpatient Digital Follow-up (I-POD) as an Adjunct to Standard Treatment According to National Guidelines in the National Trauma Plan Among Adult Trauma Patients in Norway.","A Randomized Controlled Clinical Trial to Assess the Efficacy of Tailored Patient Information and Voluntary Patient-Managed Outpatient Digital Follow-Up as an Adjunct to Standard Treatment According to National Guidelines in Adult Trauma Patients in Norway (The POSTRAUMA Trial).","POSTRAUMA","Inclusion Criteria:\n\n* 16 years or older\n* Fulfils the national criteria for TTA and admitted to HUS following trauma\n* Included in NTR database\n* Able to give informed consent\n\nExclusion Criteria:\n\n* 15 years or younger\n* Not included in NTR database\n* Deceased before discharge from the hospital.\n* Not able to give informed consent\n* Insufficient command of the Norwegian language\n* Foreign tourists or nationals\n* Suicide attempt or serious self-inflicted trauma\n* Serious psychiatric disorders or serious ongoing substance abuse",{"count":366,"type":22},256,[25],"The POSTRAUMA trial is a clinical trial at The Regional trauma centre of Western Norway, Haukeland University Hospital.\n\nTrauma is the leading cause of death worldwide in patients aged 1-45 years. In Norway, approximately 10,000 patients are admitted to hospital annually due to trauma, with 66% being male. The mean age is 43 years for male and 48 years for female, indicating a relatively young patient population.\n\nWhile mortality rates are decreasing, a significant proportion of trauma survivors experience long-term disabilities, reduced quality of life, and difficulties in returning to work. These consequences impose substantial burdens on individuals, families, and society. Considering these issues, a shift in focus is needed-from survival alone to long-term functional recovery and quality of life after trauma.\n\nSevere trauma often requires long-term follow-up, both physically and psychosocially. Traditional follow-up can be fragmented and not tailored to individual needs. Digital patient monitoring and tailored information have the potential to improve patient pathways, but knowledge about how these are experienced by patients is limited.\n\nThe goal is to find out if Norwegian trauma patients who receive tailored patient information and patient-managed outpatient digital follow-up, in addition to standard treatment have:\n\n* Less disability\n* Return more often to work\n* Improved quality of life\n\nThe study population are Norwegian trauma patients, 16 years or older at date of inclusion, who are admitted to Haukeland University hospital (HUS) following trauma with trauma team activation. 256 patients will be included in this trial.\n\nParticipants will:\n\n* Answer a questionnaire at inclusion, one month, 6 months and 12 months.\n* Participants in the intervention group will be invited to digital outpatient follow up one month after the accident.\n* Some participants will be interviewed about how they experienced their trauma follow up.",[370,371,372,373,374,375,376,377,378],"Trauma Centers","Trauma Patients","Trauma (Including Fractures)","Trauma Injury","Rehabilitation After Neurological or Orthopaedic Injuries","Rehabilitation","Return to Work","HRQOL (Health Related Quality Of Life)","EQ5D5L-VAS",[380,381,382,383,384,385],"multitrauma","trauma","rehabilitation","return to work","HRQOL","EQ5D","2025-12-16",{"date":349,"type":48},{"date":389,"type":22},"2026-03-02",{"date":306,"type":22},{"name":54,"class":55},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":237,"maxAge":19,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":228},"100539649","a-digital-treatment-for-adolescents-with-eating-disorders-100539649","NCT06306586","A Digital Treatment for Adolescents With Eating Disorders","Evaluation of a Personalised Digital Treatment for Adolescents With Eating Disorders - An Open Feasibility Trial in Routine Care","Inclusion Criteria:\n\nA. Diagnosed with F50.1 Atypical anorexia nervosa, F50.3 Atypical bulimia nervosa, F50.8 Other eating disorders, F50.9 Eating disorder, unspecified\n\nB. Age between 15 and 18 years.\n\nC. Stable dose of medication for a co-morbid psychiatric treatment for six weeks and who continue to meet study entry criteria.\n\nD. Internet access.\n\nE. Speaks and write Norwegian.\n\nExclusion Criteria:\n\nA. Diagnosed with F50.0 Anorexia nervosa or F50.2 Bulimia nervosa\n\nB. Disorders of psychological development (F80-F89).\n\nC. Patients with avoidant restrictive food intake disorders (F50.82)\n\nD. Participants with a co-morbid medical condition or disorder known to influence eating or weight (i.e., pregnancy, cancer), psychotic disorders, acute suicidality, or substance abuse and\u002For substance dependence and severe depressive episode.\n\nE. Receiving inpatient- or face to face psychological treatment.",{"count":121,"type":22},[25],"The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to:\n\ni) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic.\n\nii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders.\n\nParticipants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.",[403],"Eating Disorders",[405],"Digital interventions, eating disorders, adolescents",{"date":349,"type":48},{"date":408,"type":48},"2024-03-11",{"date":410,"type":22},"2027-01-01",{"name":54,"class":55},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":177,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100604596","evaluating-the-big-five-intervention-in-norway-100604596","NCT07151573","Evaluating the Big Five Intervention in Norway","5 Gode Vaner - En Randomisert Kontrollert Studie","Inclusion Criteria:\n\n* PHQ or GAD cutoff 5 or above\n* Residing in Norway and have a Norwegian national identity number\n* 16 years or above\n\nExclusion Criteria:\n\n* Reporting 2 or higher on PHQ item 9 (suicidality concerns)\n* Do not comprehend Norwegian or English",{"count":420,"type":22},410,[25],"This randomized controlled trial will evaluate the Norwegian adaptation of the Big Five intervention (Things You Do; TYD) for individuals with self-reported anxiety and\u002For depressive symptoms. The study will compare the Big Five intervention with a Gratitude intervention and a waitlist control. A total of 410 participants will be recruited online and randomized to one of three groups. Intervention groups will receive a brief module and daily SMS reminders (Monday-Friday for four weeks) encouraging engagement in either the five daily actions or gratitude practices. The primary aim is to replicate findings from the Australian trial by comparing TYD to a waitlist control. A secondary aim is to examine whether TYD yields better outcomes than the active Gratitude control. This study will provide evidence on the effectiveness and cross-cultural applicability of a low-cost, scalable intervention for improving mental health. Data from the study will also be used to evaluate the psychometric properties of the Norwegian translation of the Things You Do-15 instrument (TYD-15).",[424],"Anxiety Depression",[426,427,428,429,430],"Anxiety","Internet interventions","Big Five","DIgital Mental Health Intervention","Preventive interventions","2025-09-26",{"date":433,"type":48},"2025-10-01",{"date":435,"type":48},"2025-09-10",{"date":437,"type":22},"2027-09-30",{"name":54,"class":55},2,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":63,"sex":18,"minAge":208,"maxAge":448,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":228},"100552340","promoting-mental-health-in-young-children---a-dialogue-based-approach-in-kindergartens-100552340","NCT06471816","Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens","Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens: A Randomized Controlled Trial","PRO-DIALOG","Inclusion Criteria:\n\n* Attendance in kindergarten\n* Inclusion during the first half-year of the third last year in kindergarten\n\nExclusion Criteria:\n\n* Parents don't communicate in Norwegian or English","3 Years",{"count":450,"type":22},200,[25],"The goal of this clinical trial is to learn if the novel Dialogue Based Early Detection (DBED) method can prevent impaired mental health in kindergarten children. It will also learn about the screening properties of DBED to identify children with impaired mental health, if DBED facilitates early interventions, and if DBED is well accepted and sustainable in an ordinary kindergarten setting.\n\nThe main questions it aims to answer are:\n\n* Do children in kindergartens where DBED is implemented develop better mental health scores than children in kindergarten where DBED is not implemented?\n* How well identifies DBED kindergarten children with impaired mental health compared to a traditional screening instrument (the Strengths and Difficulties Questionnaire)?\n* What is the impact of DBED on activation of interventions for mental health problems?\n* What is the social validity of DBED?\n\nResearchers will compare outcomes in kindergartens where DBED is implemented with outcomes in kindergartens where it's not.\n\n* During the last three years of kindergarten attendance participants (parents of kindergarten children) in the intervention kindergartens will take part in the biannual DBED parent-teacher meetings, while participants in the control kindergartens will take part in traditional parent-teacher meetings.\n* Twice a year all participants will answer questionnaires of the child's mental health and parental stress during the follow-up period (3 years in kindergarten and 2 first years in school).\n* Participants in the intervention kindergartens will answer user satisfaction questionnaires after every parent-teacher meeting.\n* The kindergarten teachers will report on type and time of supportive interventions for each participating child during the follow-up period in kindergarten.",[454,455],"Child Behavior","Child Development",[457,458,459,460,461],"Health Promotion","Secondary Prevention","Kindergarten","Child Mental Health","Parent Involvement",{"date":433,"type":48},{"date":464,"type":48},"2024-01-01",{"date":466,"type":22},"2029-06-30",{"name":54,"class":55},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":91,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":56},"100434417","phase-2-sirolimus-vs-corticosteroids-in-treatment-of-thyroid-eye-disease-100434417","NCT04936854","Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease","Prospective Comparison of Sirolimus Against Corticosteroids in Treatment of Patients With Active Thyroid Eye Disease","Inclusion Criteria:\n\n* The participant want treatment for active thyroid eye disease and is willing to be included in the study\n* Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS) ≥ 4 (on the 7-item scale)\n* Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and\u002For inconstant or constant diplopia\n* Onset of active TED symptoms (as determined by participant records) within 9 months prior to inculsion\n* Participants must be euthyroid with the Graves disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels \\\u003C 50% above or below the normal limits).\n* Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery\u002Firradiation during the course of the study\n* Diabetic participants must have well-controlled stable disease (defined as HbA1C \\\u003C 9.0% with no new diabetic medication \\[oral or insulin\\] or more than a 10% change in the dose of a currently prescribed diabetic medication within 60 days prior to Screening)\n* Women of childbearing potential (including those with an onset of menopause \\\u003C2 years prior to Screening, non-therapy-induced amenorrhea for \\\u003C12 months prior to Screening, or not surgically sterile \\[absence of ovaries and\u002For uterus\\]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified timepoints (i.e., prior to each dose and through Week 48 of the Follow-Up Period); participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, one of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least one full cycle prior to Baseline and continue for 180 days after the last dose of study drug. Highly effective contraceptive methods (with a failure rate less than 1% per year) when used consistently and correctly, includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomized partner\n* Male participants must be surgically sterile or, if sexually active with a female partner of childbearing potential, must agree to use barrier contraceptive method from Screening through 180 days after the last dose of study drug\n* Active Influenza and Pneumococcal vaccines\n\nExclusion Criteria:\n\n* The participant dont want treatment for active thyroid eye disease or dont want to participate in the study\n* Decreased vision due to optic neuropathy as defined by a significant decrease in best corrected visual acuity, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months\n* Corneal decompensation unresponsive to medical management\n* Previous orbital irradiation or surgery for TED Any steroid use (intravenous \\[IV\\] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED. Previous steroid use (IV or oral) with a cumulative dose of \\\u003C1 g methylprednisolone or equivalent for the treatment of TED and previous use of steroid eye drops is allowed if the corticosteroid was discontinued at least 4 weeks prior to inclusion\n* Corticosteroid use for conditions other than TED within 4 weeks prior to inclusion (topical steroids for dermatological conditions and inhaled steroids are allowed)\n* Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the clinical trial; however, taking a multivitamin that includes selenium and\u002For biotin is allowed\n* Use of any other non-steroid immunosuppressive including agent, new biologic drugs within 3 months prior to Screening\n* Use of an investigational agent for any condition within 60 days prior to inclusion or anticipated use during the course of the trial\n* Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results\n* Bleeding diathesis that in the judgment of the Investigator would preclude inclusion in the clinical trial\n* Malignant condition in the past 12 months (except successfully treated basal\u002Fsquamous cell carcinoma of the skin)\n* Pregnant or lactating women\n* Current drug or alcohol abuse, or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the participant\n* Biopsy-proven or clinically suspected inflammatory bowel disease\n* Known hypersensitivity to any of the components Sirolimus.\n* Any other condition that, in the opinion of the Investigator, would preclude inclusion in the study\n* Previous enrollment in this study\n* Human immunodeficiency virus (HIV), tuberculosis, hepatitis C or hepatitis B infections",{"count":121,"type":22},[95],"The purpose of this study is to determine whether Sirolimus is more effective and burdened with less side effects than conventional treatment with corticosteroids in patients with active thyroid eye disease.",[479],"Thyroid-Associated Ophthalmopathy",[481,482,483,484,485],"Thyroid eye disease","Graves' Orbitopathy","Immunosuppressive Agents","Exophthalmos","Sirolimus","2025-09-19",{"date":488,"type":48},"2025-09-22",{"date":490,"type":48},"2023-01-01",{"date":110,"type":22},{"name":54,"class":55},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":518,"locationsCount":56},"100596224","behavioral-therapy-and-glp-1-analogue-effects-on-binge-eating-weight-and-coping-in-obesity-100596224","NCT07042672","Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity","Behavioral Therapy With and Without GLP-1 Analogue in Patients With Morbid Obesity and Binge Eating Disorder: A Clinical Prospective Observational Study on Body Weight, Binge Eating Behavior, and Harmful Coping Strategies","BETTER-GLP1","Inclusion criteria\n\n1. Severe obesity defined as BMI \\>40 kg\u002Fm2 or 35 kg\u002Fm2 with obesity-related comorbidities: coronary artery disease, heart failure, hypertension, atrial fibrillation, cerebral stroke, venous thromboembolism, obstructive sleep apnea, obesity hypoventilation syndrome, type 2 diabetes mellitus, non-alcoholic fatty liver disease, dyslipidemia, osteoarthritis and polecystic ovary syndrome\n2. Age between 18 to 65 years\n3. Diagnosis of BED according to DSM-5 criteria\n4. Willingness to participate and provide informed consent\n5. Able to understand and communicate in Norwegian\n\nExclusion criteria\n\n1. Pregnant or lactating women, as well as women planning pregnancy within one year.\n2. Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication)\n3. Renal failure with estimated glomerular filtration rate less than 30 mL\u002Fmin\u002F1,73m2\n4. Liver failure with either ASAT and\u002For ALAT 5 times upper reference limit, or ALP and\u002For GT more than 3 times upper reference limit, or clinical signs of liver decompensation\n5. Active cancer\n6. Previous medullary thyroid cancer\n7. Previous pancreatitis\n8. Active substance abuse (but previous drug abuse accepted)\n9. Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months.\n10. Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program\n11. Any illness or prior treatment that in the opinion of the investigator would jeopardize the patient's participation in the study or impact integrity and\u002For quality of study data.\n12. Previous bariatric surgery\n13. Use of appetite suppressing drugs (e.g., GLP-1 analogues and\u002For naltrexone\u002Fbupropion) within the last 6 months\n14. Participation in another clinical study involving an investigational medicinal product within 1 month prior to study inclusion","65 Years",{"count":503,"type":22},80,"This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED.\n\nThe primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions.\n\nAdult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions.\n\nChanges in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.",[506,507,508,403,509,510,511],"Binge Eating Disorder Associated With Obesity","Binge Eating Disorder","Eating Disorder Binge","GLP-1","CBT","Obesity &Amp; Overweight","2025-09-09",{"date":514,"type":48},"2025-09-15",{"date":516,"type":48},"2025-07-01",{"date":139,"type":22},{"name":54,"class":55},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":63,"sex":18,"minAge":90,"maxAge":527,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":545,"locationsCount":56},"100590730","phase-2-nadream-effects-of-nicotinamide-adenine-dinucleotide-supplementation-on-sleep-quality-in-healthy-individuals-100590730","NCT06971224","NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals","NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals: A Randomized Controlled Pilot Study","NADream","Inclusion Criteria:\n\n* Participant must be 40 to 60 years of age inclusive, at the time of signing the informed consent.\n* Male or female.\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the study protocol.\n* Self-reported normal sleep patterns, assessed by Pittsburgh sleep quality index (PSQI; cutoff ≤ 5).\n* No current use of sleep medications or supplements.\n* Able to wear polysomnographic equipment and actigraphy during nighttime.\n\nExclusion Criteria:\n\n* History of sleep disorders (e.g. insomnia, sleep apnea).\n* Abnormal findings on PSG, such as sleep related breathing disorders (apnea-hypopnea index (AHI) ≥ 5), sleep related movement disorders (periodic limb movement index (PLMI) ≥ 15, and parasomnias (like REM sleep behavior disorder (RBD)).\n* Chronic use of alcohol, tobacco, or medications affecting sleep.\n* Significant psychiatric or medical conditions (including neurological, heart, lung, or sleep disorders\u002Fdiseases).\n* Travelled \\>1 time zone and night work \\\u003C1 month before study, or during the study.\n* Extreme chronotype according to the Composite Morningness Questionnaire (evening type; \\\u003C22 and morning type \\>44).\n* Pregnancy.\n* Breastfeeding.\n* Supplements resulting in \\> 20 mg daily of nicotinamide riboside, nicotinamide mononucleotide (NMN), niacin (vitamin B3, nicotinic acid amide or other vitamin B3 analogues) less than 3 months prior to randomization.\n* Participation in other clinical trials last 3 months.\n* Deemed ineligible by lead principal investigator.","60 Years",{"count":529,"type":22},16,[95],"The purpose of this study is to evalue the effects of nicotinamide adenine dinucleotide (NAD) supplementation (nicotinamide riboside (NR) form) on sleep in healthy adults compared to a placebo. NAD is important for brain health and energy balance and a proposed explanation for its effect on sleep is that NAD supplementation restores the neurophysiological capacity of the brain to 'rest' during sleep. If this is the case, we expect the administration to result in improvements in sleep quality (and most likely sleep quantity) compared to placebo. Participants will receive either NAD supplementation or a placebo and their sleep will be measured to detect any differences between the two groups.",[533],"Sleep",[533,535,536,537,538,539,540],"Nicotinamide Riboside","NR","Nicotinamide adenine dinucleotide","NAD","Polysomonography","PSG",{"date":514,"type":48},{"date":543,"type":22},"2025-10-13",{"date":165,"type":22},{"name":54,"class":55},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":554,"enrollmentInfo":555,"targetDuration":556,"studyType":66,"phases":4,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":56},"100541380","right-colectomy-for-colon-cancer-database-rcc-surgical-technique-route-of-access-and-quality-of-the-specimen-100541380","NCT06329102","Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen","Right Colectomy for Colon Cancer Database","RCC","Inclusion Criteria:\n\n* Patients with malignant tumor of the right colon at CT and\u002For colonoscopy.\n* Confirmed adenocarcinoma\n* Patients medically cleared by anesthesiologist for general anesthesia and oncological radical resection\n* Informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years\n* Patients with recurrent cancer after previous surgery\n* Patients with ongoing treatment due to other cancer","99 Years",{"count":21,"type":22},"5 Years","Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power.",[559,560,561],"Right Sided Colon Cancer","Right Colectomy","Lymphadenectomy",{"date":514,"type":48},{"date":564,"type":48},"2021-01-01",{"date":566,"type":22},"2030-09-01",{"name":54,"class":55},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":590,"locationsCount":56},"100539080","a-therapist-guided-internet-delivered-treatment-for-adults-with-adhd-attention-deficit--hyperactivity-disorder---an-open-effectiveness-trial-in-routine-care-100539080","NCT06299189","A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit \u002F Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care","A Therapist Guided Internet-delivered Treatment for Adults With ADHD - an Open Effectiveness Trial in Routine Care","MinADHD","Inclusion criteria: \\|\n\n* Age ≥18\n* A self-reported diagnosis of ADHD\n* Access to and ability to use a computer, smartphone and the Internet.\n* Speaks, writes and reads Norwegian\n\nExclusion criteria:\n\n* In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis.\n* Ongoing psychological treatment for ADHD or other psychiatric illnesses.",{"count":450,"type":22},[25],"The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:\n\ni) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.",[580,581,582,583],"ADHD","ADHD - Combined Type","ADHD Predominantly Inattentive Type","ADHD, Predominantly Hyperactive - Impulsive","2025-08-25",{"date":586,"type":48},"2025-08-26",{"date":464,"type":48},{"date":589,"type":22},"2027-09",{"name":54,"class":55},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":18,"minAge":287,"maxAge":177,"enrollmentInfo":598,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":605,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":56},"100556966","effectiveness-of-a-digital-application-for-adolescents-with-mild-to-moderate-anxiety-100556966","NCT06531980","Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety","Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst","Inclusion Criteria:\n\n* Ages 13-16\n* Resides in Bergen\n* Completed RCADS-25\n* Reports \"yes\" to both questions:\n* Do you have anxiety symptoms? Do you often feel stressed, scared, worried, or feel it in your body (e.g., stomach pain, heart palpitations, breathing problems, sweating, dizziness)?\n* Do anxiety symptoms prevent you from doing things you want or need to do (e.g., meeting new people, giving presentations at school, going to sleepovers, going to the shopping center)? Or do you spend so much time worrying that it affects your daily life? Can read Norwegian\n\nExclusion Criteria:\n\n* Currently receiving other psychological treatment\n* Immediate need for other psychological treatment, such as severe depression, suicide risk, OCD, psychosis\u002Fsubstance abuse issues, autism spectrum disorder\n* Anxiety is largely related to bullying\n* Extensive school absence of more than 50% in the last three months",{"count":599,"type":22},128,[25],"The goal of this randomized controlled trial is to investigate the effectiveness of a new therapist-guided rule based intervention in Bergen Municipality, Child and Family help center.\n\nDo they have a decrease in anxiety symptoms following the intervention? Do they have an increase in functional level following the intervention?\n\nResearchers will compare the therapist-guided rule based intervention with treatment as usual for adolescents with mild to moderate anxiety.\n\nParticipants will use the intervention, which is based on CBT, for 8 weeks.",[426,603,604],"Anxiety and Fear","Adolescent - Emotional Problem",[606,607,608,609,610],"Digital Health","Digital interventions","Cognitive behavior therapy","adolescent","anxiety","2025-08-22",{"date":613,"type":48},"2025-08-28",{"date":615,"type":48},"2025-01-16",{"date":617,"type":22},"2026-12-30",{"name":54,"class":55},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":63,"sex":18,"minAge":236,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":636,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":650},"100496444","effects-of-long-term-ventilation-support-on-the-quality-of-life-of-als-patients-and-their-families-100496444","NCT05744310","Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families","ALS-LTMV","Inclusion criteria for patients:\n\n1. A clinical diagnosis of probable ALS according to the revised El Escorial criteria\n2. Progression of the illness leading the consulting physician to offer treatment with LTMV\n3. Can communicate in Norwegian\n\nInclusion criteria for partners of ALS patients:\n\n1. Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nInclusion criteria for children:\n\n1. Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nExclusion criteria for patients, partners and children of ALS patients:\n\n1\\. Potential participants with cognitive impairment or dementia.",{"count":450,"type":22},[25],"Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality.\n\nThe present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.",[630,631,632,633,634,635],"Amyotrophic Lateral Sclerosis","Motor Neuron Disease","Nervous System Diseases","Spinal Cord Diseases","Neurodegenerative Diseases","TDP-43 Proteinopathies",[637,638,639,640,641,642,643],"Quality of life","Overall quality of life","Health related quality of life","Disease specific quality of life","Ventilation support","Non-invasive ventilation support","Invasive ventilation support",{"date":613,"type":48},{"date":646,"type":48},"2023-04-21",{"date":648,"type":22},"2032-08-21",{"name":54,"class":55},9,{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":660,"briefSummary":661,"conditions":662,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":56},"100531419","phase-1-a-study-to-investigate-treatment-of-hu-and-vpa-or-6-mp-and-vpa-in-unfit-amlhr-mds-patients-100531419","NCT06199557","A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML\u002FHR-MDS Patients","A Phase 1\u002F2 Multicenter Open-label Study to Investigate Treatment of Hydroxyurea in Combination With Valproic Acid (VPA), or 6- Mercaptopurine in Combination With VPA in Patients With AML or HR-MDS Unfit for Standard Therapy","HUVAMER","Inclusion Criteria:\n\nParticipants are eligible for the study only if all of the following criteria apply:\n\no Female or male, age 18 years or older\n\n* Written informed consent\n* Patients with Newly diagnosed AML, as defined by ELN 2022 criteria, or relapsed\u002Frefractory AML who: - are unfit, defined as HCT-CI ≥ 3, or - in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n\n  * the patient has declined standard therapy\n\nNewly diagnosed HR-MDS, or relapsed\u002Frefractory HR-MDS who:\n\n* are unfit, defined as HCT-CI ≥ 3, or\n* in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n* has declined standard therapy\n\nSecondary AML (MDS-related\u002F therapy- induced), or\n\nAcute promyelocytic leukemia not eligible for standard therapy and\u002For specific therapy.\n\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n\n  * Serum creatinine ≤1.5 x ULN;\n  * Estimated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault equation);\n  * Hepatic function;\n\n    i. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); ii. Aspartate aminotransferase (AST)\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iii. Alanine aminotransferase (ALT)\n\n    \u003C!-- -->\n\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iv. Alkaline phosphatase (ALP)\n\n    1\\. ≤2.5 × ULN\n* European Cooperative Oncology Group (ECOG) performance status 0, 1, 2 or 3\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to taking their first dose of study medication. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for \\>3 months after the last dose of study medication. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:\n\n  1. Natural menopause with last menses \\>1 year ago\n  2. Radiation induced oophorectomy with last menses \\>1 year ago\n  3. Chemotherapy induced menopause with last menses \\>1 year ago\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Patients on treatment for AML (any anti-leukemic therapy including investigational agents) or treated less than 2 weeks before inclusion.\n* Concurrent history of active malignancy in the past six months prior to diagnosis except for\n\n  * basal and squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease et cetera) at the investigators discretion.\n* Breastfeeding women\n* Cardiac dysfunction as defined by:\n\n  * myocardial infarction within the last 3 months of study entry, or\n  * congestive heart failure NYHA class IV or\n  * unstable angina, or\n  * unstable cardiac arrhythmias\n* SARS-CoV-2 infection \\\u003C 7 days or Covid-19-vaccine \\\u003C 7 days from study onset\n* Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.\n* Patients with any serious concomitant medical condition that could, in the opinion of the investigator, compromise participation in the study.\n* Patients with senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.\n* Known hypersensitivity to study medications or its excipients.\n* Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":5,"type":22},[153,95],"The purpose of this study is to investigate the safety, tolerability, and preliminary efficacy of the combination treatment of hydroxyurea capsules and valproic acid capsules, or the combination treatment of 6-mercaptopurine tablets and valproic acid capsules in male and female patients aged 18 years or older with acute myeloid leukemia or high- risk myelodysplastic syndrome.\n\nThe population to be studied is newly diagnosed AML patients who are considered unfit for standard induction chemotherapy, HR-MDS unfit\u002Fineligible for standard treatment, and relapsed\u002Frefractory AML\u002FHR-MDS patients who are considered unfit for standard therapy ,or are, for some reason, ineligible for another type of therapy. Clinically, hydroxyurea, valproic acid and 6-mercaptopurine are historically very well-known therapeutic agents with low toxicity profiles. The rationale for this study is that the combination of these drugs with low toxicity will be well tolerated in elderly AML patients with comorbidities, or lower performance status. This combination could have a beneficial therapeutic effect on overall survival and contribute to a better quality of life.",[663,664],"Acute Myeloid Leukemia, Adult","Myelodysplastic Syndromes, Adult","2025-06-25",{"date":667,"type":48},"2025-06-29",{"date":669,"type":48},"2024-05-23",{"date":671,"type":22},"2029-09-30",{"name":54,"class":55},{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":679,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":23,"phases":682,"briefSummary":683,"conditions":684,"keywords":687,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":56},"100592839","feasibility-of-a-digital-intervention-for-patients-frequently-admitted-to-psychiatric-acute-wards-100592839","NCT06998654","Feasibility of a Digital Intervention for Patients Frequently Admitted to Psychiatric Acute Wards","Feasibility of a Digital Intervention for Patients Frequently Admitted to Psychiatric Acute Wards: the MULI App Study","MULI","Inclusion Criteria patients:\n\n* older than 18 years\n* reside in one of the study municipalities\n* admitted into the Muli service\n* have had at least three admissions into the psychiatric acute ward in the last 12 months\n\nInclusion criteria, healthcare workers:\n\n\\- staff members at the local psychiatric hospital who respond to patient contacts made through the app\n\nExclusion criteria, staff:\n\n\\- staff members at the local psychiatric hospital who rare not tasked with responding to patient contacts made through the app.",{"count":7,"type":22},[25],"This qualitative feasibility study investigates a digital health app designed for patients who are frequently admitted to the psychiatric acute ward, to facilitate crisis support outside of office hours to avoid unnecessary readmissions, as well as self-harm. As this is a novel app to be implemented in an already existing service, key uncertainties regarding the intervention content and its delivery needs to be addressed before potentially conducting a full-scale trial, or, alternatively, to inform further intervention refinement. Such uncertainties are appropriate to explore in a feasibility study according to the Medical Research Council (MRC) framework for the development and evaluation of complex interventions.\n\nThere is a need to investigate whether the app is acceptable and useful to the patients using it, and to the healthcare providers who respond to it. There is also a need to know whether the healthcare providers responding to the app find the task manageable. The context in which the staff are to deliver the intervention, i.e. the in-bed ward, may be subject to different barriers, such as a staff shortage due to sick leave and heavy workload in the ward. Such barriers are essential to identify ahead of possible future trials in other contexts.",[685,606,686],"Mental Health Help-Seeking","Readmissions",[688,689,690,691],"Digital mental health intervention","self help","crisis support","readmissions","2025-05-29",{"date":694,"type":48},"2025-05-31",{"date":696,"type":22},"2025-06-12",{"date":698,"type":22},"2026-12-31",{"name":54,"class":55},""]