There are about 11176 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The study investigates the short- and long-term impact of a major organizational change on employee health and productivity. Changes in organizations is a common aspect of modern work life in all sectors and public healthcare is no exception. However, emerging evidence suggests that organizational changes may be a potential stressor which can impact on employee well-being and contribute to stress-related health problems. Using a large-scale natural experiment, the overall aim of the study is to investigate the impact of a major organizational change that took place during 2016-19 on employee health and productivity. In addition, we aim to identify groups that may be at increased risk of experiencing negative consequences of the reorganization. These at-risk groups can in turn be candidates for extended preventive measures when planning future major organizational changes.
Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions.
The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who: - have advanced or metastatic breast cancer that is spread to other parts of the body. - have HR+/HER2- (hormone receptor positive* / human epidermal growth factor receptor 2 negative**) breast cancer types. - Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment. - Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment. - have started treatment in the period between January 2017 and December 2021. The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023.
Fabry is a rare X-linked metabolic lysosomal disorder caused by deficiency in the enzyme α-galactosidase A (alpha-Gal A) by mutations in the GLA gene, encoding the alpha-Gal A enzyme, which catalyses glycosphingolipids, namely globotriaosylceramide (Gb3). Reduced or absent alpha-Gal A activity leads to accumulation of Gb3 in various organs as well as cellular dysfunction and inflammation causing phsyical symptoms and eventual organ failure. Treatment has been available since 2001 for Fabry patients - first enzyme replacement therapy and since 2016, an oral chaperone therapy, Migalastat. Although the initial trials of Migalastat had some both short and extended outcome treatment comparisons, the overall evidence of clinical efficacy is based on too small numbers considering the heterogeneity of the Fabry patient population as well as the very slow progression of the disease. Though the body of real-world evidence is growing, there is a need for more publications of real-world long-term data on clinical outcomes with a focus on treatment with Migalastat. Research Question: Is the incidence and prevalence of Fabry associated clinical events (FACEs) (cardiac, renal, and cerebrovascular) associated with sex, genotype, phenotype at time of diagnosis, biomarkers, and Fabry specific therapy? Objectives: - To investigate time to first Fabry associated clinical events (FACE) (cardiac, renal, and cerebrovascular) with particular focus on Migalastat clinical outcomes and treatment outcomes preceding Migalastat therapy. - To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment. - To describe FACEs in accordance with different geno- and phenotypic groups. - To investigate the incidence and time to a first fatal or non-fatal cardiac, renal, and cerebrovascular clinical event, separated by each category. Primary outcomes - Time to first FACE (cardiac, renal, and cerebrovascular) with particular focus on Migalastat on clinical outcomes and treatment outcomes preceding Migalastat therapy. Secondary outcomes - To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment. - To describe FACEs in accordance with different geno- and phenotypic groups To investigate the incidence and time to a first fatal or non-fatal cardiac, renal and cerebrovascular clinical event, separated by each category. Exploratory outcomes - To describe disease progression with focus on organ involvement. The study design is a retrospective clinical and paraclinical follow-up of the Danish National Fabry cohort in the period 01.01.2001-31.12.2022. Patient followed a structured yearly monitoring program as part of routine clincal care.
Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring. The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored. The individual studies are detailed below:
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins. Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required. A novel catheter to achieve PVI called the HELIOSTARâ„¢ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure. In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up.
Breathlessness is a common problem for many patients with Interstitial lung disease (ILD). ILD is a group of lung diseases that cause inflammation (swelling) and scarring in the lung tissue where gas exchange (oxygen and carbon dioxide) occurs. Unfortunately, there is no cure for these conditions and as a result many patients decline over time with worsening breathlessness. This limits their ability to live a good life. Clinicians do not often recognize, assess, or treat breathlessness appropriately. Breathlessness, being a subjective experience, cannot be fully understood through objective measurements such as lung function tests, the arterial blood gas test etc. The objective and subjective measures of breathlessness are frequently disconnected. Clinicians who often rely on these types of objective tests do not directly enquire into its nature and severity of breathlessness from patients themselves. As a result, they remain unaware of this disabling symptom and the extent of its impact on patients. While there are many tools to measure breathlessness, they are not consistently used in routine care or have impacted care in a meaningful way. Many such tools are also complex with intricate response systems with possibility of errors and user fatigue. As a result, easy to use tools like modified MRC or MRC are frequently used even though they do not assess severity of breathlessness. No tool has been effective at helping clinicians identify the problem and prescribe appropriate treatments. This results in needless suffering for patients and their families and prevents them from receiving timely and appropriate therapies. Investigators propose to test an easy-to-use tool that combines the subjective and objective aspects of breathlessness. Investigators hope that the tool will help clinicians quickly identify the patient's breathlessness severity and provide them with an algorithm of what to do next. The tool was developed by clinicians with +15 years of experience in ILD and dyspnea. Early analysis already suggests the tool is useful to patients and helps improve care.
This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.
The purpose of the study is to investigate the ability of mass spectrometry imaging to locate aggregates of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) ex-vivo, and to distinguish areas containing these carcinomas from normal skin. It is suggested that non-melanoma skin cancer (NMSC) cells show a different profile of endogenous lipids than healthe skin tissue which can be used as identifying biomarkers. If that hypothesis is correct it will be possible in the future to develop real-time tissue diagnosis and treatment of NMSC using mass spectrometry guided surgery. Method between 60 and 100 patients with BCCs, SCCs, and actinic keratoses (AK) will be recruited. For patients referred for Mohs surgical procedure at the Department of Dermatology, Bispebjerg Hospital, to treat BCCs or SCCs, three skin sections (5-10 um thick) of the tissue that is already removed will be use in our study. One section will be HE stained so we know exactly where the regions of interest are. Two sections will be used for MS analysis (MSI spectrum and REIMS spectrum). When patients are referred for a procedure to have treated several actinic keratoses (grade 1, 2 or 3) at Department of Dermatology, Bispebjerg Hospital we will take an extra punch biopsy (2-4 mm) depending on the size of the lesion. The biopsy is embedded and sectioned. We will use 3 skin sections (5-10 um thick) we will again use one section for HE staining and two for MS analysis. Multivariate statistical analysis will be performed on all mass spectra using Matlab or similar program. Linear discriminant analysis will be used to identify spectral differences between pre-malignant, cancer and normal tissue. Classification performance will be recorded with a leave-one- patient- out cross- validation scheme.