[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Bergen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":283},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,66,98,129,155,182,206,226,249],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100640573","effectiveness-of-implementing-the-adapted-practice-guidelines-for-primary-care-of-acute-abdomen-in-zambia-an-effectiveness-implementation-hybrid-type-2-study-design-100640573",false,"NCT07587190","Effectiveness of Implementing the Adapted Practice Guidelines for Primary Care of Acute Abdomen in Zambia: An Effectiveness-Implementation Hybrid Type 2 Study Design.","Inclusion Criteria:\n\n* Data from all patients 18 year and older with acute abdomen including surgical, gynecological and medical acute abdomen managed at the intervention site and control site will be collected during the study period.\n\nExclusion Criteria:\n\n* All cases of acute abdomen secondary to trauma will be excluded from the study. All patients in the immediate postoperative phase operated from other facilities presenting with acute abdomen.","ALL","18 Years",{"count":18,"type":19},280,"ESTIMATED","INTERVENTIONAL",[22],"NA","The study aims 1) to adapt, 2) to develop implementation strategies for and 3) to evaluate the effect of implementing a practice guideline for acute abdomen at primary care level in Zambia. We employ a sequential exploratory mixed method study design. Qualitative and quantitative data from health care workers will be used to adapt a practice guideline developed in a high-income into a low- and middle-income (LMIC) context and to develop strategies for successful implementation. The primary outcome of interest is the prospective change in length of stay in hospital among patients presenting with acute abdomen in the intervention site compared to the control site. The study will address the scarcity of literature on practice guidelines for acute abdomen in the LMIC context. The implementation of an adapted guideline may contribute to a reduction of the morbidity and mortality rates associated with acute abdomen in this setting by increasing management capacity at the primary care level.",[25],"Practice Guidelines for Primary Care of Acute Abdomen",[27],"Acute Abdomen, Practice guidelines, Primary Health Care, Adaptation, Implementation Strategies, Effectiveness-Implementation Hybrid Type 2 Study Design","RECRUITING","2026-05-08",{"date":31,"type":32},"2026-05-14","ACTUAL",{"date":34,"type":32},"2025-09-01",{"date":36,"type":19},"2028-12-31",{"name":38,"class":39},"University of Bergen","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100595130","effects-of-proactive-call-to-customers-of-norsk-rikstoto-horse-gambling-operator-in-norway-a-randomized-controlled-study-100595130","NCT07028450","Effects of Proactive Call to Customers of Norsk Rikstoto (Horse Gambling Operator in Norway): A Randomized Controlled Study","Effects of Proactive Calls: A Randomized Controlled Study","Inclusion Criteria:\n\n* Being identified (based on an algorithm used by Norsk Rikstoto\u002Fthe gambling provider) as a high risk gambler at least 5 of the last 30 days\n\nExclusion Criteria:\n\n* Previously received a proactive call from Norsk Rikstoto","50 Years",{"count":50,"type":19},195,[22],"Customers\u002Fgamblers gambling at Norsk Rikstoto (gambling monopolist in Norway providing horse gambling products with potential gambling problems will be randomly allocated to receive a proactive phone call (encouraging them to change their gambling behavior - e.g., be lowering the loss limit) or to a control condition. Outcomes will be short and long terms registered gambling behavior.",[54],"Gambling Problem",[54,56,57,58],"Proactive calls","Randomized controlled trial","mini-intervention",{"date":60,"type":32},"2026-05-11",{"date":62,"type":32},"2026-02-16",{"date":64,"type":19},"2026-12-31",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100408753","obesity-and-oral-diseases-in-adult-patients-100408753","NCT04602572","Obesity and Oral Diseases in Adult Patients","ObOd","Inclusion Criteria:\n\n* Obese adult patients.\n* Patients referred to the Obesity Clinic at the Hospital.\n\nExclusion Criteria:\n\n* Unwillingness to participate.","20 Years","70 Years",{"count":76,"type":19},400,"OBSERVATIONAL","Overweight and obesity are among the major chronic disorders of the 21st century and one of the fastest growing health problems worldwide. Obesity is accompanied by a state of low-grade inflammation which may contribute to the occurrence of diabetes mellitus, cardiovascular disease, hypertension, stroke, and certain cancers. Furthermore, obesity has been associated with oral health problems as hyposalivation, dental caries and periodontitis.\n\nThe management and treatment of obesity is outlined in clinical guidelines from American Association of Clinical Endocrinologists\u002FAmerican College of Endocrinology and European Association for the Study of Obesity. The cornerstone is life-style modification programs aiming to reduce energy intake and increase physical activity, referred to as conservative treatment. All patients must undergo a thorough systematic work-up. The work-up concludes in a final multi-disciplinary meeting with a concrete individualized plan on how sustained weight-loss is to be achieved; either by a non-surgical or a surgical approach (Bariatric surgery).\n\nPeriodontitis is cited to be the sixth most prevalent chronic condition globally. The mechanisms by which obesity affects the periodontal tissues is poorly understood, and the understanding of the key role of adipocytes in the inflammatory response to infections is crucial in comprehending how periodontal disease susceptibility may be modified in obese individuals.\n\nThe main objectives of the present research project are to explore the association between obesity and oral diseases and further, to assess how weight changes following non-surgical and surgical interventions of obese patients may affect the cariological and periodontal health status.\n\nFour hundred patients referred to the Obesity Centre at Haukeland University Hospital, Norway will consecutively be screened and invited to participate in this prospective cohort study. At baseline, detailed medical and oral data will be obtained from health forms, questionnaires, clinical examinations, and by consulting the patient's care team. Following baseline examination, all patients will undergo a thorough systematic work-up consisting av interviews and consultations concluding in a final multi-disciplinary individualized non-surgical or surgical treatment plan on how sustained weight-loss can be achieved. New sets of medical, oral, and molecular data will be collected at 3-, 12- and 18-month following non-surgical\u002Fsurgical interventions.",[80,81,82,83,84],"Obesity","Oral Diseases","Periodontitis","Dental Caries","Dental Erosion",[80,86,82,87,88,89],"Overweight","Caries","Bariatric surgery","Oral health","NOT_YET_RECRUITING","2026-05-04",{"date":29,"type":32},{"date":94,"type":19},"2026-11-01",{"date":96,"type":19},"2027-12-31",{"name":38,"class":39},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":15,"minAge":16,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":20,"phases":109,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100602932","unified-protocol-group-treatment-in-a-university-outpatient-clinic-100602932","NCT07129941","Unified Protocol Group Treatment in a University Outpatient Clinic","Transdiagnostic Group Treatment of Emotional Disorders: A Cross-sectional and Naturalistic Study of Outcome, Change Processes, and Clinical Training","Inclusion Criteria:\n\n* Age 18-40\n* Fulfilling diagnostic criteria for an anxiety disorder and\u002For unipolar depression (ICD F.3x - 4x)\n* Motivated for short-term treatment in group format\n\nExclusion Criteria:\n\n* Suicidality\n* Self-harm\n* Severe psychiatric disorder (bipolar disorder, psychosis)\n* Substance use disorders\n* Use of anxiolytic medication (i.e., benzodiazepines)\n* Unstable antidepressant medication (i.e., stable dosage \\\u003C6 months)\n* Other ongoing psychological treatment",true,"40 Years",{"count":108,"type":19},140,[22],"This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. The study will involve 140 patients receiving UP treatment in a group format, delivered either by experienced or novice therapists, along with a non-clinical control group of 45 participants. Participants will self-refer on the basis of advertisement about the study through flyers, posters, project website, social media or local news media. Outcomes will be assessed through self-report measures of well-being, symptoms, emotion regulation, and the non-specific factors of treatment credibility and therapeutic alliance. Additionally, psychophysiological measures of heart rate variability and interoception will be used to explore processes influencing treatment response. Qualitative interviews will complement the quantitative data by capturing participants' perspectives on the treatment and experiences of what contributed to change.",[112,113,114],"Emotional Disorders","Anxiety","Depression - Major Depressive Disorder",[116,117,118,113,119,120],"Unified Protocol","Transdiagnostic treatment","Emotional disorders","Depression","Group therapy","2025-08-11",{"date":123,"type":32},"2025-08-19",{"date":125,"type":32},"2025-05-08",{"date":127,"type":19},"2034-12",{"name":38,"class":39},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":20,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":154,"locationsCount":40},"100550813","virtual-darkness-theraphy-for-agitation-in-dementia-100550813","NCT06451952","Virtual Darkness Theraphy for Agitation in Dementia","Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial","DARKDEM","Inclusion Criteria:\n\n* Patients admitted to NKS Olaviken gerontopsychiatric hospital\n* Diagnosis of dementia, all stages and etiologies,\n* ≥50 years\n* both genders\n* Clinically significant agitation (CMAI ≥45)\n\nExclusion Criteria:\n\n* Total blindness\u002Fdiminished bilateral red reflex.\n* Use of melatonin\n* Clinically significant pain (MOBID-2≥3)",{"count":138,"type":19},72,[22],"Behavioral and psychological symptoms of dementia (BPSD) such as anxiety, depression, psychosis and agitation, are prevalent, often treatment resistant, resource demanding and significantly deteriorates cognition, independency, quality of life and mortality in people with dementia.\n\nThe DARK.DEM trial aims at developing new diagnostics and treatment for BPSD in both specialized and municipal dementia care.\n\nThe investigators will develop digital phenotyping by determining the convergent validity of data from a smartwatch against established psychometric scales for BPSD for patients admitted to NKS Olaviken gerontopsychiatric hospital.\n\nThe investigators will conduct an open label single blinded randomized controlled trial to determine the effectiveness, feasibility and safety of virtual darkness as adjunctive treatment of agitation in patients with dementia admitted to the hospital. The investigators will randomize minimum 72 patients to treatment as usual (psychotropic drugs, psychological and environmental interventions) or 14 days of virtual darkness therapy, that is, exposure to light deprived of blue wavelengths from 19.00-08.00, provided in a secluded patient unit with circadian lightening. Primary outcome is 14 days change in agitation assessed with Cohen-Mansfield Agitation Inventory. Secondary outcomes are change in diurnal variation of motor activity assessed with a smartwatch and sleep monitor, other BPSD, activities of daily living, quality of life, use of psychotropic drugs, use of restraints and coercion, length of hospital stay and resource utilization.\n\nThe investigators will conduct focus group interviews with managers and staff in nursing homes to explore barriers, enablers and adaptions to support implementation of the new methods in municipal dementia care",[142],"Agitation in Dementia, Including Alzheimer's Disease",[144,145,146,147],"virtual darkness theraphy","agitation in dementia","randomized controlled trial","gerontopsychiatric hospital","2025-04-08",{"date":150,"type":32},"2025-04-11",{"date":152,"type":32},"2024-09-30",{"date":64,"type":19},{"name":38,"class":39},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":15,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":181,"locationsCount":40},"100549676","decoding-death-and-dying-in-people-with-dementia-by-digital-thanotyping-100549676","NCT06437132","Decoding Death and Dying in People With Dementia by Digital Thanotyping","5-D","Inclusion Criteria:\n\n* Nursing home resident\n* \\>64 years old\n* People with dementia or who have a likely diagnosis of dementia\n* Score of \\\u003C4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)\n\nExclusion Criteria:\n\n* People without dementia or cognitive impairment\n* People that are considered already in a health status emergency (\\\u003C 6 weeks to live)\n* People that are not living in the nursing home\n* People without informed\u002Fpresumed consent","65 Years",{"count":164,"type":19},480,"How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms).\n\nThe aim of Decoding Death and Dying in Dementia by Digital thanotyping (5-D) is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now, focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups. 5-D combines clinical assessment tools with wearable sensing technology to monitor a) pain and distressing symptoms, b) behavioral and psychological symptoms in dementia (BPSD), c) oral changes, and to decode \"the point of no return\" as the beginning of perceived dying.\n\nTo obtain this outcome in nursing home patients with dementia, the investigator will test the main hypothesis: from monitoring the evolution of thanotype components over time and their interdependencies, the prediction of the \"point of no return\" is possible. The objectives of 5-D are:\n\nO1. Collect data using sensors and validated assessment scales. O2. Develop estimation methods for BPSD from sensor measurements. O3. Develop digital tools to capture the expression of pain. O4. Determine the relationship between breathing and oral symptoms. O5. Develop models for symptom interdependencies at the end of life and the \"point of no return\".\n\nO6. Perform human-in-the-loop validation of developed tools, models, and algorithms.\n\nThe ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia. Advancing our theoretical knowledge to uncover how, when, and why perceived dying can be identified opens the doors for transferable research across several scientific fields",[167],"Dementia",[169,170,171,172,173,174],"end of life","dementia","nursing home","pain assessment and treatment","symptom assessment and treatment","mouth care","2024-05-25",{"date":177,"type":32},"2024-05-31",{"date":179,"type":32},"2024-01-01",{"date":36,"type":19},{"name":38,"class":39},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":40},"100416724","comparison-of-the-immune-response-to-natural-covid-19-infection-and-vaccination-100416724","NCT04706390","Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination","COVID19vac-1","Inclusion Criteria:\n\n* subjects prioritized by national vaccination program\n\nExclusion Criteria:\n\n* Children\n* unable or unwilling to provide informed consent","100 Years",{"count":191,"type":19},2500,"The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.",[194],"Covid19",[194,196,197],"Vaccine","SARS-CoV-2 antibody","2024-04-18",{"date":200,"type":32},"2024-04-19",{"date":202,"type":32},"2021-01-12",{"date":204,"type":19},"2030-12-12",{"name":38,"class":39},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":40},"100491648","plaque-burden-and-ischemia-in-minoca-100491648","NCT05681858","Plaque Burden and Ischemia in MINOCA","Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries","Inclusion Criteria:\n\n* Acute chest pain\n* Elevated troponin\n* Non-obstructive coronary arteries by coronary angiography\n\nExclusion Criteria:\n\n* Obstructive coronary artery disease\n* Contraindications against CT coronary angiography or stress \\[12N\\] NH3 PET-MR\n* Not able to give informed consent",{"count":214,"type":19},100,"The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:\n\n* Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA\n* Assess presence, extent and severity of myocardial ischemia in MINOCA\n\nParticipants will examined by CT coronary angiography and stress \\[12N\\] NH3 PET-MR.",[217],"MINOCA","2023-11-28",{"date":220,"type":32},"2023-12-04",{"date":222,"type":32},"2023-08-15",{"date":224,"type":19},"2027-08",{"name":38,"class":39},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":40},"100498683","aneed-joint-effort-21-ehealth-and-a-ppi-program-in-dementia-with-lewybodies-dlb-100498683","NCT05773443","ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)","A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial to Demonstrate Clinical Efficacy on Cognitive, Neuropsychiatric and Functional Outcomes of Ambroxol in New and Early Patients With Prodromal and Mild Dementia With Lewybodies (ANeED) - Joint Effort 21: eHealth and a PPI-program in Dementia With Lewybodies (DLB)","JointEffort21","Inclusion Criteria:\n\nA patient is eligible when all inclusion criteria and none of the exclusion criteria are fullfilled in the ANeED study:\n\n1. Male or female.\n2. Age ≥ 50 and ≤ 85 years of age.\n3. Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).\n4. MMSE score\\>=15\n5. Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1.\n6. Capable of complying with all study procedures.\n7. Willing to provide blood samples for genetic analyses of APOE and GBA.\n8. Willing and able to self-administer or administer by a caregiver oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)).\n9. Able to travel to the participating study site.\n10. A female participant is eligible to participate if she is of:\n\nNon-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 - 134.8 IU\u002FL and oestradiol \\\u003C 201 pmol\u002Fl at entry.\n\nWomen of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.\n\nExclusion Criteria:\n\n1. Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.\n2. Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.\n3. Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study;\n4. Confirmed dysphagia that would preclude self-administration of ambroxol up to 6 tablets daily for the duration of day 1 to day 550\u002FMonth 18.\n5. Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.\n6. History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, copovidone and magnesium stearate) in the opinion of the investigator that contraindicates their participation.\n7. History of known rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.\n8. History of illegal substance abuse, drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the study.\n9. Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of the study drug.\n10. Pregnant or breastfeeding; All participants of child bearing potential in the opinion of the Investigator that would preclude participation in the study and who do not agree to use double-barrier birth control or abstinence while participating in the study and for two weeks following the last dose of study drug;\n11. Any clinically significant or unstable psychiatric, medical or surgical condition that in the opinion of the PI or PI-delegated clinician may put the participant at risk when participating in the study or may influence the results of the study or affect the participant's ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests.\n\n    Such conditions may include:\n    1. Impaired renal function\n    2. Moderate\u002FSevere hepatic impairment\n    3. A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, pulmonary embolism, coronary revascularisation that occurred within 6 months prior to the screening visit.\n    4. Major depression, delirium or psychosis not related to DLB.\n    5. Metastatic cancer or terminal illness.\n12. Planned major surgery or other major treatments during study period that will interfere with study-obligations.","85 Years",{"count":214,"type":19},"The goal of the study is to develop predictive algorithms and digital biomarkers to capture disease fluctuations in (prodromal) dementia with lewybodies (DLB) patients and to improve treatment, diagnosis and prognosis of the study drug Ambroxol, used in the ANeED study. This project is an additional study to the ANeED study, registered at ClinicalTrials.gov under NCT04588285.",[238],"Dementia, Lewy Body",[240],"dementia, lewy, wearable, sensor, digital, device, monitoring, actigraphy","2023-03-06",{"date":243,"type":32},"2023-03-17",{"date":245,"type":19},"2023-03",{"date":247,"type":19},"2026-12",{"name":38,"class":39},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":15,"minAge":257,"maxAge":74,"enrollmentInfo":258,"targetDuration":4,"studyType":20,"phases":260,"briefSummary":261,"conditions":262,"keywords":269,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":40},"100434955","dietary-strategies-for-remission-of-type-2-diabetes-100434955","NCT04943926","Dietary Strategies for Remission of Type 2 Diabetes","Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)","CARBCOUNT","Inclusion Criteria:\n\n* HbA1c ≥48 mmol\u002Fmol (with or without medical treatment)\n* Less than 10 years since the diagnosis of T2D\n* BMI ≥27 kg\u002Fm2 (≥25 kg\u002Fm2 for Asians)\n\nExclusion Criteria:\n\n* Treatment with insulin \\>25 IU\n* HbA1c concentration of 12% or more (≥108 mmol\u002Fmol)\n* Insulin to C-peptide ratio \\\u003C0.8 (indicative of insulin deficiency)\n* Myocardial infarction within the previous 6 months, and severe or unstable heart failure or other severe diseases including cancer, psychiatric\u002Feating disorders, severe depression and substance abuse","24 Years",{"count":259,"type":19},600,[22],"In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs\u002Fcapabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in\u002Fcan be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal\u002Fhepatic fat accumulation, adipose tissue biopsies and\u002For measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.",[263,264,265,266,267,268],"Diabetes Mellitus, Type 2","Overweight and Obesity","Hypertension","Glucose Intolerance","Insulin Resistance","Dyslipidemia Associated With Type II Diabetes Mellitus",[270,271,272,273,274],"Low-carbohydrate high-fat diet","Energy restricted diet","Lifestyle change","Ketogenic diet","Total meal replacement","2022-07-04",{"date":277,"type":32},"2022-07-08",{"date":279,"type":32},"2022-01-04",{"date":281,"type":19},"2040-12-31",{"name":38,"class":39},""]