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.
PURPOSE The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology. In the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET
Objectives of the phase 2 prospective, multicenter, randomized, double-blind, placebo-controlled study is to assess safety and efficacy of TRO40303 administered just before balloon inflation during percutaneous coronary intervention (PCI) for limitation of infarct size in patients treated for acute myocardial infarction (AMI). The study is being conducted in 9 centres in Sweden, Denmark, Norway and France. One hundred eighty patients will be included. It will last one month per patient and its overall duration will be 11 months. The efficacy will be assessed by infarct size expressed as area under the curve for creatine kinase and troponin I (blood sampling at D1, D2 and D3), and also evaluated by Cardiac Magnetic Resonance. Safety will be assessed by - clinic evaluation, - blood samples (hematology, biochemistry, renal and hepatic function), - Recording and follow-up of major adverse events occurring during the first 48h after reperfusion (death, heart failure, AMI, stroke, recurrent ischemia, the need for repeat revascularization, renal or hepatic, vascular complication and bleeding). - ECG - Recording cardiac events during one month after AMI - Follow-up of global left ventricular function by Echocardiography at D3 and D30. Demographic and medical history at inclusion and non-cardiac events occurring during the first 30 days will be recorded. TRO40303 plasma concentration will be assessed at 15 min, 6h, and 12h post the end of administration. Sample size calculation assuming a reduction of 35% of the AUC for Troponin I release, for a statistical power of 85% and a probability of type I error of 0.05. Main analysis: between-group comparisons of AUCs for serum troponin I and CK release will be performed using O'Brien's method for multiple endpoints testing. Secondary analysis: comparisons of the CMR criteria described above will be performed using mixed model of ANCOVA. All analyses will be performed on the Full Analysis Set and Per protocol populations. Safety analysis: A comparison of the incidence of cumulative adverse clinical events between the groups will be performed by Fisher's exact tests. Subjects will undergo primary PCI and receive concomitant medications according to current standard of care. After coronary angiography is performed but just before balloon inflation is performed, patients who meet the enrollment criteria will be randomly assigned to either the control group or the TRO40303 group. Randomization is ensured by taking the treatment units in ascending and consecutive order in each strata (anterior/posterior as determined on ECG). Just before balloon inflation, ideally less than 5 minutes, and with a maximum of 15 minutes before balloon inflation and stenting, the patients in the TRO40303 group will receive an intravenous slow-bolus (35 mL/min) injection of 6 mg/kg of TRO40303 injected in peripheral IV. The patients in the control group will receive an equivalent volume of the placebo. Patients will be hospitalized for as long as there is a medical indication. CMR and echocardiography will accordingly be conducted as in/out patient between day 3 (ideally) and 5. A follow-up visit will be conducted one month after PCI.
An increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute. This randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. We hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.
On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is required. The cost of these admissions vary according to the type of injury with hip fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total average cost of a severe hip fracture in the Danish healthcare system resulting in nursing home placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year {{288 Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who sustain a hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the outcome of falling in the elderly population is therefore not only associated with severe human but also economical consequences. Hence, it is essential to refine, develop and think "out of the box" when future intervention programs are designed and employed in the elderly community. One such "out of the box" intervention could be balance training with a Nintendo Wii Fit board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is a new generation of computer game which uses 3D tracking of the participants' motion and gestures. This means that the user interacts in and controls elements of the 3D gaming world with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it detects the body sway and center of pressure (COP) of the participant and displays it onto a TV screen in different balance sceneries. A virtual character on the TV then reacts according to the user's movement and gesture (ex. skiing down a ski slope passing thru gates). This enables the user to perform tasks that, they may not be able to execute safely or at all in real-world situations. Interestingly in this context a study by Sihvonen et al from 2004 showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D and with a poor graphical display. Further, the Sihvonen-study showed that 2D "biofeedback" intervention of only 4 weeks proved successful in terms of improved postural balance, physical activity and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods when promoting physical activity in the elderly population has been limited by lack of motivation or poor compliance (REFS), which possibly has prevented the elderly from reaching a maximum rehabilitation potential(REFS). Furthermore, in the follow-up period after these traditional intervention studies, it has been documented how difficult it is for the elderly to sustain the same training volume on themselves (REFS). Virtual reality systems like the Nintendo Wii Fit have been developed specifically for rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L. 2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion, speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these systems have not become commercially available possible due to a very high cost {{294 Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to be constructed from scratch making the hole process and implication very complicated {{306 Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost ready-to-use Wii Fit platform could be a possible research direction to explore. At the moment few studies have been conducted using the Nintendo Wii console. Among the few some have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294 Deutsch,J.E. 2008; }}. To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii Fit balance training in seniors (+65 years). The main purpose of the study is to investigate the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors (+65 years of age) have a significant effect on postural balance and muscle strength.
The aim of the study is to evaluate the effect of progressive resistance strength training (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional training would improve the rehabilitation and increase the level of activity of daily living.
An adequate calcium intake is important for bone turnover and the risk of developing osteoporosis. Yet many studies have documented that supplementation with calcium tablets are often associated with a poor compliance, therefore it is important to explore ways to better calcium influx. Calcium consumed through dairy products must first be cleaved from the molecules which it is bound to before it can be absorbed. Chymosin is an enzyme which cleaves the protein binding between some amino acids in κ-casein. The reaction occurs after ingestion of milk and causes a process whereby the time the milk is staying gastrointestinal tract is extended, this can lead to enhanced uptake of calcium. When the body's calcium balance is in equilibrium excretion in urine (24 h) in roughly the size of the intake, whereby a measurement of circadian urine excretion of calcium can determine the amount of calcium absorbed from the intestine. The investigators want to clarify whether the addition of chymosin to milk increases calcium absorption. Secondary to explore issues of significance for this effect, including vitamin D status and amount of daily calcium intake and whether a change in calcium absorption has immediate effects on bone turnover (measured as plasma osteocalcin, bone specific alkaline phosphatase (BSAP), and the renal excretion of cross-linked N-terminal telopeptide of type 1 collagen (NTx/Cr) ratio) and on the parathyroid function (measured as PTH). Finally we will explore relations between bone mineral density (BMD) and the measured parameters (in terms of P-PTH, P-25OHD, P-1,25(OH)2D, P-osteocalcin, P-BSAP, and U-NTx/Cr).
This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.
This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773
The investigators wish to determine the lumped constant (LC), which is a correction factor necessary for converting measurements of hepatic FDG metabolism (measured by PET) to those of regular glucose in patients with cirrhosis and healthy subjects. Working hypothesis - LC for FDG in liver tissue is not significantly different from unity in healthy subjects - LC for FDG in liver disease is significantly different from LC in healthy liver - Insulin changes the LC for FDG in liver tissue, but not by the same factor in liver disease and healthy subjects.