Box Hill, Clayton, Garran, Kogarah, Ringwood East, Australia
Virtual Leisure - Virtual Reality Delivered Recreation at a Closed Psychiatric Ward
Phase
N/ASpan
105 weeksSponsor
Mental Health Services in the Capital Region, DenmarkCopenhagen
Recruiting
Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers
Phase
N/ASpan
235 weeksSponsor
University of CopenhagenCopenhagen
Recruiting
Healthy Volunteers
Re-hospitalisation After Transcatheter Aortic Valve Implantation
Phase
N/ASpan
113 weeksSponsor
Ole De BackerCopenhagen
Recruiting
Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache
Phase
N/ASpan
52 weeksSponsor
Danish Headache CenterCopenhagen
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/ASpan
307 weeksSponsor
Hvidovre University HospitalCopenhagen
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
1/2Span
281 weeksSponsor
Princess Maxima Center for Pediatric OncologyCopenhagen
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
3Span
353 weeksSponsor
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/ASpan
186 weeksSponsor
Copenhagen University Hospital, HvidovreCopenhagen
Recruiting
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
Phase
N/ASpan
253 weeksSponsor
Rigshospitalet, DenmarkCopenhagen
Recruiting
Personalized Hemodynamic Management in High-risk Major Abdominal Surgery
not provided
Phase
N/ASpan
117 weeksSponsor
Universitätsklinikum Hamburg-EppendorfCopenhagen
Recruiting