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.
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
Ultrasonography has become increasingly used in many medical specialties over the last decades as smaller and less expensive ultrasound equipment has become available. Although ultrasound imaging traditionally is considered safe, its use is highly operator dependent (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that eventually compromise patient safety due to unnecessary tests or interventions (Moore & Copel 2011). A recent report from the British National Health Service (NHS) analyzed maternity claims reported to the NHS over the past decade and identified antenatal fetal ultrasound investigations as one of the four major risk areas in obstetric care (NHS 2012). This study therefore aims to explore the effects of simulation-based ultrasound training on patient comfort levels and the need for re-examination by a second physician due to diagnostic uncertainty.
This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Disturbed glucose metabolism is a common feature of patients with end-stage renal disease (ESRD). Several hormones responsible of a stable blood glucose including insulin, glucagon, and the gastrointestinal insulinotropic hormones Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) are elevated in patients with ESRD. These hormones are all medium sized peptides which theoretically makes them removable during high efficient hemodialysis. A significant removal could have consequences for the treatment of patients with diabetes and ESRD. The purpose of this study is to determine whether insulin, glucagon, GLP-1 and GIP are cleared during high efficient hemodialysis and hemodiafiltration. The investigators hypothesize that a significant amount of these hormones is removed during hemodialysis and to a larger extend during hemodiafiltration.
Early intervention with the Marte Meo method. Aim to study whether the program have effect on: Maternal confidence, maternal stress, maternal mood (EPDS), dyadic synchrony (Infant care index), and infants social competences (ASQ:SE)
Pregnant women with pre-eclampsia and growth restricted fetuses often have a reduced function of the placenta. This is accompanied by an increased perinatal mortality and morbidity. By ultrasound it is possible to measure blood flow and vascular resistance in both the fetal umbilical cord and in the blood vessels supplying the uterus. A high resistance in these vessels occur before the child is severely affected. By immersion in water extracellular fluid is redistributed back into the circulation, and central blood volume increases. Previous studies have shown that maternal minute-volume increases, while blood pressure drops slightly. Also an increased amniotic fluid has been recorded. This has been interpreted as an expression of increased renal blood flow. Immersion into water could increase blood flow in the vessels supplying the uterus and thus increase blood flow to the child. The investigators aim to clarify this by examining blood flow and resistance in the blood vessel supplying the uterus and in the umbilical cord, while the participant is immersed into water. Initially, 25 healthy women with an uncomplicated singleton pregnancy recruited from the Department of Obstetrics and Gynaecology: Hvidovre University Hospital, Denmark, will be examined. The participant will act as its own control and measurements above water and immersed will be conducted at the same study session. Ultimately the investigators seek to contribute to a non-invasive option for prolonging those pregnancies where the fetus and/or maternal condition requires delivery several weeks before term, and where immersion of the pregnant woman in the water a few hours one to several times daily, may prolong the pregnancy the required number of hours/days for antenatal steroid treatment to be sufficient. There are no risks associated with the study and the project team considers it ethical to implement this. The study is not supported by pharmaceutical companies or other groups with economic interests. The project group itself has taken the initiative to study.
Primary objective: - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by HbA1c reduction, in older type 2 diabetes patients (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM patients (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: - To assess the effect of lixisenatide compared to placebo after 24-week treatment on: - Fasting plasma glucose (FPG) - During liquid standardized breakfast meal challenge test : 2 hour- PPG and Plasma Glucose Excursion - 7-point Self-monitored plasma glucose (SMPG) profile - Body weight - Change in total daily dose of basal insulin (if taken) - Percentage of patients requiring rescue therapy - Safety and tolerability - To assess lixisenatide pharmacokinetic profile - To assess anti-lixisenatide antibody development.