There are about 11304 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.
Recently a common Greenlandic nonsense p.Arg684erTer variant (in which arginine is replaced by a termination codon) in the gene TBC1D4 was discovered. The variant has an allele frequency of 17%. Homozygous carriers of this TBC1D4 variant have impaired glucose tolerance and a 10-fold enhanced risk of developing type 2 diabetes (T2D). The investigators propose to carry out comprehensive metabolic phenotyping of adult Inuits carrying zero or two alleles of the TBC1D4 variant. The investigators hypothesise that regulation of TBC1D4 in skeletal muscle is pivotal in regulating glucose uptake during exercise, during physiological insulin stimulation, and for the ability of an acute bout of exercise to improve insulin sensitivity to regulate glucose metabolism in humans. The overall aims in the present project are to: 1. Determine whether the TBC1D4 p.Arg684Ter variant affects the regulation of glucose uptake in skeletal muscle during exercise and during physiological insulin stimulation. 2. Determine the effect of the TBC1D4 p.Arg684Ter variant for the ability of acute exercise to insulin sensitize skeletal muscle to regulate glucose metabolism. 3. Define the metabolic pathways affected by the p.Arg684Ter variant in order to identify causal factors responsible for the diabetic phenotype of Inuit carriers. The knowledge generated will contribute to additional explanatory clues to the increased frequency of T2D in the carriers.
It is well documented that the formation of the early relation between parents and infant has a significant impact on the child's mental, social and cognitive development and competencies. The early relationship formation in the first year in the infants' life gets the best conditions when parents are able to interpret, understand and respond to the infants signal adequately. Symptoms of mental illness can affect a person's ability to respond to their environment and thereby their parenting capabilities. Research have found that parental psychopathology may interfere with a healthy interaction with the infant by reducing the ability to be sensitively attuned and responsive to the infant's signal, needs and cues due to the nature of the psychiatric symptoms. The aim of this study is to investigate what potential lies within the postpartum stay at the obstetric department and in the transition to the primary health care sector for vulnerable families and to develop an intervention that will help increase the parents sensitivity towards their new born infant in order to enter a healthy early relationship formation which will be measureable on short term in the prevalence of maternal post-partum depression. The study is a prospective mixed-method study consisting of three sub-studies. The first study is a register-based study which aims to investigate how the proportion and the absolute risk of children with predefined adverse developmental outcomes is distributed between families defined as level three or four compared to families defined as level one and two. The second study aims to uncover needs and preferences of the vulnerable families and to investigate the experiences of the health care professionals. It is explored by in-depth family interviews with families discharged from the obstetric department and focus group interviews with health care professionals (nurses and health visitors) who are responsible for the care delivered to vulnerable families. Subsequently an intervention study will be developed, adapted, implemented and evaluated. The intervention will be carried out at the obstetric department at Hvidovre hospital and in transition to the primary healthcare sector using components from family focused nursing (FFN) and neonatal behavioral observational sessions (NBO) in addition to what have appeared in the two first sub-studies. The aim of the intervention is to facilitate family consciousness of their resources'' and increase parental sensitivity in order to foster the best possible prerequisites for a healthy early relationship formation between parent and infant. The study population consists of mothers with anxiety or depression diagnosis giving birth at Hvidovre hospital. The register-based study will provide population based information on the characteristics of vulnerable families focusing on the adverse outcomes for the children. The qualitative interviews will contribute with in-depth knowledge about preferences and experiences in relation to the care offered within the extended stay at the obstetric department and in the transition to primary health care sector and everyday life for vulnerable families. The enactment, implementation and evaluation of the intervention will determine whether the combination of FFN, NBO and improved collaboration between the obstetric department and the health visitor is associated with increased family function and increased parental sensitivity among parents in the intervention group compared to the control group. Effect from baseline (24-48 hours post-partum) to follow-up (3 months post-partum) will be measured on both the mother, the parents and the infant focusing on depression symptoms (primary outcome), parental stress, parental reflective function, mother-baby interaction, couple relationship satisfaction, infants' self-regulation, family function and breastfeeding Descriptive statistics will be applied in order to detect associations. Power calculations showed that with a significance level of 5% and a power of 80% 55 families are needed in the control and the intervention group, respectively, in order to detect statistically difference. This PhD study will contribute with a new perspective on the potential of the time immediately after birth and the potential effect of early intervention to improve prerequisites for increased family function and early healthy relationship formation for vulnerable families. The study will provide knowledge and experience about the practical application of both FFN and NBO at the obstetric department which have never been done in a Danish context before. It is expected that the study as a whole may impact and benefit clinical nursing as well a public health.
In this study, the investigators wish to explore the optimal student ratio in the simulated setting for subsequent skills transfer. The study aims to explore if there are differences in the effect of collaborative learning as a function of the number of collaborators with respect to future individual learning and transfer. Additionally, the investigators will aim to get a better understanding of the interactive processes that take place during collaborative learning. Many different theories have been used to understand collaborative learning, but few observational data have been reported in the medical literature. To gain a deeper understanding of what happens and why, the investigators plan to video record participants during their initial training and code the videos using the ICAP framework. The ICAP framework was developed by Chi in 2009 and is based on students' behaviours to reflect different modes of engagement in learning. The four behavioural modes are described as passive (P), active (A), constructive (C) and interactive (I) and each mode is associated with different examples of learning activities that can be coded. The ICAP theory proposes a hierarchical distribution of learning activities, where interactive activities are superior to constructive activities, which are superior to active activities, which are superior to passive activities (I>C>A>P). The investigators aim to investigate if this framework can serve as a conceptual framework to describe the activities that takes place during training and if these activities can be related to learning outcomes.
The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.
The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).
Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain. Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (M1). Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current Stimulation (tDCS) administered to brain regions linked to the resting state motor network (network-tDCS) could enhance corticomotor excitability in healthy participants compared to single site M1-tDCS. It remains unknown whether network-tDCS has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs associated with prolonged pain
The purpose of this study is to investigate the efficacy of high definition tDCS on different cortical targets in modulating the nociceptive system in the healthy subjects.
Mitochondrial diseases, estimated prevalence 1 in 4,300 adults, is caused by pathogenic mutations in genes finally encoding for mitochondrial proteins of the various enzyme complexes of the OXPHOS. Among these mutations, the 3243A>G nucleotide change in the mitochondrially encoded transfer RNALeu(UUR) leucine 1 gene (MT TL 1) is the most prevalent one. The OXPHOS dysfunction resulting from such mutations leads to increased production of reactive oxygen species (ROS), ultimately leading to irreversible oxidative damage of macromolecules, or to more selective and reversible redox modulation of cell signaling that may impact (adult) neurogenesis. Despite advances in the understanding of mitochondrial disorders, treatment options are extremely limited and, to date, largely supportive. Therefore, there is an urgent need for novel treatments. KH176, a new active pharmaceutical ingredient (API), is an orally bio-available small molecule under development for the treatment of these disorders (see Section 1.4). The current study will further evaluate the effect of KH176 in various cognitive domains and evaluate the effect of different doses of KH176 (See Section 1.5). In view of the growing recognition of the importance of mitochondrial function in maintaining cognitive processes in the brain, as well as the understanding of the safety profile and pharmacokinetics of KH176 following the two clinical studies described above, a more detailed study is indicated of the effects of KH176 in various cognitive domains, using the confirmed safe and well-tolerated KH176 dose of 100 mg bid, as well as a lower dose of 50 mg bid. The primary objective is an evaluation of KH176 in the attention domain of cognitive functioning, as assessed by the visual identification test score of the Cogstate computerised cognitive testing battery.
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema. The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity. The morphology will be described using T2-weighted non-contrast MRI.
The overall objective of the project is to develop a collaboration model between the patient, the patient's General Practitioner (GP) and the cardiologist at the hospital in a seamless collaborative model dubbed the "Cardio-relay model". The specific purpose of the pilot project is to ease performing heart rhythm monitoring with focus on diagnosis and evaluation of atrial fibrillation (AF), for patients who have difficulties to attend repeated visits to the hospital-based outpatient clinic. With available eHealth technologies the cardiologist can access data gathered at the patient's side to provide support to the GP for selecting patients with need for heart rhythm monitoring, plan further evaluations and guide therapeutic decisions. These patients can thereby receive support that without the burden of attending physical meetings at the cardiologist office. The investigators evaluate if the cardio-relay model allows to complete evaluation of frail patients compared to usual care and if patients experience are sufficiently confident accessing the cardiologist through the cardio-relay model.