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.
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.
The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. Even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. On this basis, this project will test a new recognition process that uses the relevant WHO-HPH tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. The project is deigned as a RCT, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. Then, after one year, the control group also begins the recognition process (= delayed start), while the Intervention group (=immediate-start) continues with the recognition process. Doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. The outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. Such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. Physical, mental, and social health status among patients and staff will be measured by short form (SF36).
The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery
This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.
The operating room, OR, is a high-tech and complex domain in which clinicians' possession of clinical knowledge and good technical skills are essential, but not sufficient. Retrospective studies have shown that a large proportion of the mistakes that occur during surgery are not caused by lack of clinical skills but rather by insufficient communication and teamwork. Prospective studies have shown that insufficient teamwork in the OR causes a higher risk of complications and that communication failure in the surgical team causes procedural errors and delays. It is therefore evident, that surgeons and the surgical teams need skills in communication, teamwork, decision making and leadership (so called non-technical skills) to ensure a good outcome for surgical patients. Internationally different behavioural marker systems have been developed to aid training and assessment of non-technical skills such as Non-Technical Skills for Surgeons (NOTSS) from Scotland (12). In Denmark certain aspects of non-technical skills appear in the curricula for surgical trainees, but no formal training or assessment occurs at this point. The investigators developed a behavioural marker system for general surgeons adapted to the Danish cultural and organisational context (NOTSSdk). The behavioural marker system consists of four categories: leadership, situation awareness, decision making and communication & teamwork. Each category has between 3 and 4 elements underpinning it and each element has several behavioural examples illustrating good and poor behaviour. The system needs evaluation to ensure that it is valid and can be used reliably to observe and rate surgeons' intra operative performance. Aim: The aim of this study is to examine the psychometric properties of NOTSSdk in relation to it's construct validity, reliability, and usability in a simulated setting. Research questions: - What is the inter rater reliability among raters? - Are these ratings consistent with expert ratings (= "gold standard ratings")? - Can a one day training session improve novice raters' agreements (construct validity)? METHODS The study is designed to explore the reliability of the ratings made by surgeons as well as to examine whether the reliability improves with training. The study setting will be a one day course in which surgeons are asked to rate the non-technical performance of surgeons in simulated video scenarios. Two distinct sets of ratings will be obtained. The first at the beginning of the day when the surgeons have had no prior training in or knowledge of rating non-technical skills and at the end of the day after 5 hours of training. Sample A sample of general surgeons from all hospitals in Zeeland, Denmark will be recruited to participate as raters after the heads of the departments have been contacted and informed about the project. The investigators wish to recruit consultant surgeons (n=10) and senior residents in surgery (n=10) who have an interest in education and supervision. Once recruited background information such as age, gender, position, years of surgical experience and prior experience with assessment of others will be collected. Training and rating session The surgeons will attend a one day course. The course will consist of three parts: first a rating session to get baseline-ratings from participants of 6 video scenarios, then a teaching and training session and then another rating session with 4 new and 2 of the baseline-videos. During the first rating session the surgeons will only have the NOTSSdk rating form and will not be allowed to discuss with each other. The second rating session will be like the first but in addition to the rating form the participants will also be allowed to look in the full NOTSSdk behavioral marker system. The teaching will include an introduction to Human Factors and non-technical skills in surgery, and a short description of the development and intended use of NOTSSdk. The following training will allow participants to practice the rating of surgeons' non-technical skills on 4 video recorded scenarios and then discuss their ratings. Ratings of the lead surgeons' performance will be obtained at the category level of each scenario. Video recordings 14 simulated video recordings will be made showing general surgeons "acting" in their own roles during surgery. The scenarios will be scripted to display various scenarios of routine (such as unnoticed prolongation of a laparoscopic appendectomy) and non-routine situations (such as unexpected bleeding during open surgery). The scenarios will be designed after a specific structure aiming at a specific variation in the surgeons' non-technical performance according to the four categories of NOTSSdk.
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.
Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also to a greater thermogenic effect causing greater increase in core temperature. The involvement of peripheral appetite-regulating hormones has only been sparingly investigated. The objective is to investigate the satiating effects of meals with varying content of meat-based protein and whether a dose-response effect can be found on appetite-regulating hormones and appetite ratings. Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The test meals is isocaloric with 30E% fat and increasing protein content at the expense of carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch.
The aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications.
The primary aim is to examine the effect of a high protein intake (from soy or whey protein) on weightmaintenance after weight loss in a group of predisposed (severe) obese persons. Furthermore, to examine short-term and long-term effect of a high protein intake on appetite regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on weightmaintence, bloodlipid profilen, appetite regulation and DIT. The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet) and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0), after the WL period (week 8) and after WM period (week 24) body weight and composition will be measured and blood samples will be collected. Meal test will be performed at week 0 and 24 (examining both appetite regulation and DIT). Urine and feces will be collected three times during the study. Subjects will receive dietary counseling (in groups) regularly during the study and body weight will be measured at each visit.