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  • Virtual Leisure - Virtual Reality Delivered Recreation at a Closed Psychiatric Ward

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    Mental Health Services in the Capital Region, Denmark

    Copenhagen

    Recruiting

  • Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers

    Phase

    N/A

    Span

    235 weeks

    Sponsor

    University of Copenhagen

    Copenhagen

    Recruiting

    Healthy Volunteers

  • Re-hospitalisation After Transcatheter Aortic Valve Implantation

    Phase

    N/A

    Span

    113 weeks

    Sponsor

    Ole De Backer

    Copenhagen

    Recruiting

  • Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache

    Phase

    N/A

    Span

    52 weeks

    Sponsor

    Danish Headache Center

    Copenhagen

    Recruiting

  • COPD at a Street Level

    The study consists of three sub-studies: A. a descriptive cross-sectional study "The prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic" followed by study B a cohort study "The effect of opportunistic screening for COPD among socially vulnerable individuals who come in contact with a mobile clinic", based on a closed cohort, and study C "A qualitative study of patient experiences with screening and treatment of COPD. People in the lower social classes are at increased risk of developing COPD due to their lifelong accumulation of risk factors, such as smoking, passive smoking and the influence of lifestyle and the environment. In the group with the socially vulnerable individuals, 70% are smokers compared to 18% in the general Danish population. The socially vulnerable individuals are defined here as people affected by homelessness, drug abuse, harmful alcohol consumption, mental illness and poverty. Despite the socially vulnerable group having an over-consumption of general practice visits, 25% of socially vulnerable individuals state that they do not have contact with or use their own doctor. Our hypothesis is therefore that there will be a higher incidence of COPD among socially vulnerable persons who come in contact with the mobile clinic. Purpose: To investigate and describe the prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic and to investigate the effect of opportunistic screening for COPD in these vulnerable citizens, followed by a qualitative study of patient experiences with COPD treatment. Data collection: Baseline data from the cross-sectional study are derived from lung function measurement and REDCap online-questionnaires completed on inclusion. The data from the cohort study regarding disease burden and hospital visits originates from the national patient registry (LPR) and mortality data is retrieved from the Danish Register of Causes of Death. Data regarding redeemed prescriptions for COPD medicine originates from the Prescription Database. The patients' connection to the job market and income status are based on extracts from RAS (Registry-based Labour Force Statistics), which is administered by Statistics Denmark. Data regarding the highest acquired education (HFAUDD) is from Statistics Denmark. Variables: There will be collected the following variables at inclusion: information on demographics, lung function, selv-reported information on: risk factors, socioeconomic variables and symptoms of lung disease. Moreover register data on socioeconomic status, morbidity, physical health by Charlson score, mortality, hospital visits and prescriptions for COPD Medicine will be retrieved after a 1 year follow-up. Sample size: To detect a difference between the patient group and the Danish population of minimum 100% a total of 511 participants are needed in the study (power of 80%, p-values=0,05, an estimated COPD prevalence of 4,3% in the Danish population). The collected data will be kept in accordance to the Data Protection Agency guidelines. The studies are carried out in accordance with the principles of the Helsinki Declaration.

    Phase

    N/A

    Span

    307 weeks

    Sponsor

    Hvidovre University Hospital

    Copenhagen

    Recruiting

    Healthy Volunteers

  • HEM ISMART-D: Trametinib + Dexamethasone + Chemotherapy in Children with Relapsed or Refractory Hematological Malignancies

    HEM-iSMART is a master protocol with sub-protocols. The overarching objective is that introducing targeted therapy using a biomarker driven approach for treatment stratification may improve the outcome of children with R/R acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) It is characterized by a shared framework that allows for the investigation of multiple IMPs and generate pivotal safety and efficacy evidence within the sub-protocols to establish and define the benefits and risks of new treatments for children with R/R leukemia. Sub-Protocol D within HEM-iSMART, is a phase I/II, multicenter, international, open-label clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of trametinib in combination with dexamethasone, cyclophosphamide and cytarabine in children, adolescents and young with R/R ALL and LBL. Patients with actionable alterations in the RAS-RAF-MAPK pathway will be eligible for sub-protocol D including but not limited to KRAS, NRAS, HRAS, FLT3, PTPN11, MAP2K1, MP2K1 hotspot mutations, cCBL; NF1 del.

    Phase

    1/2

    Span

    281 weeks

    Sponsor

    Princess Maxima Center for Pediatric Oncology

    Copenhagen

    Recruiting

  • An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

    This is a multicenter, open-label, Phase 3 study in up to approximately 1400 participants. Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A. This study will consist of the following periods: less than or equal to (≤) 10-week screening assessment period, up to 36-month treatment period, and up to 6-month post-treatment evaluation period.

    Phase

    3

    Span

    353 weeks

    Sponsor

    Ionis Pharmaceuticals, Inc.

    Copenhagen

    Recruiting

  • Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial

    This trial will investigate if pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) leads to respiratory symptom relief (CAT score) and improvements on secondary outcomes in patients unable to access conventional rehabilitation programs (standard PR offer). Our hypotheses in a three-arm RCT design are 1. PTR and HPR will be equivalent to each other 2. PTR and HPR will be superior to usual care, that is the control group (CON - no intervention)

    Phase

    N/A

    Span

    186 weeks

    Sponsor

    Copenhagen University Hospital, Hvidovre

    Copenhagen

    Recruiting

  • Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

    Phase

    N/A

    Span

    253 weeks

    Sponsor

    Rigshospitalet, Denmark

    Copenhagen

    Recruiting

  • Personalized Hemodynamic Management in High-risk Major Abdominal Surgery

    not provided

    Phase

    N/A

    Span

    117 weeks

    Sponsor

    Universitätsklinikum Hamburg-Eppendorf

    Copenhagen

    Recruiting

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