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.
Acute kidney injury (AKI) is a frequent problem in the intensive care unit (ICU) affecting more than 50 % of patients. AKI is associated with several adverse outcomes, including increased mortality and increased length of ICU- and hospital stay, in particular in patients requiring Renal Replacement Therapy (RRT). Choosing the optimal time for attempting liberation from RRT is still unclear. With this study, we will describe the ability of renal ultrasound in predicting the outcome of dialysis weaning.
The study aim to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) on postprandial glucose metabolism and food intake in healthy volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in healthy subjects.
To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo
Implant placement in the posterior part of the maxilla is frequently compromised or impossible due to atrophy of the alveolar process and pneumatisation of the maxillary sinus. Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with implant placement. The most commonly used method to augment the maxillary premolar and molar region involves the maxillary sinus floor augmentation applying the lateral window technique with a grafting material. However, the lateral window technique is associated with prolonged patient treatment time and increased morbidity. Thus, osteotome-mediated sinus floor elevation (OSFE) with or without the use of a grafting material has been advocated, when the residual bone height is more than 6 mm. OSFE involves preparation of implant site through the use of concave osteotomes and elevation of the maxillary sinus floor. The survival of suprastructure and implants after OSFE with or without the use of a grafting material has never been assessed in long-term randomized controlled trials. A long-term study concluded that OSFE with no grafting material is a predictable treatment modality. High short-term implant survival rates after OSFE with or without the use of a grafting material have been reported in systematic reviews. However, the amount of new bone formation after OSFE with the use of a grafting material is significantly higher compared to the use of no grafting material, as documented in a systematic review. Harvesting of autogenous bone graft is associated with risk of donor site morbidity and bone substitutes of natural transplants involves a risk of contamination, activation of host immune system and disease transmission as well as they can be refused by patients for religious reasons or because they are in contrast with chosen lifestyle. Therefore, the objective of the present study is to test the H0-hypothesis of no difference in the long-term implant treatment outcome after OSFE with Bio-Oss Collagen compared with the use of no grafting material. A total of 40 consecutively healthy patients with a missing posterior tooth in the maxilla will be allocated at random to OSFE with Bio-Oss Collagen or no grafting material and simultaneous implant placement. Clinical and/or radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography (CBCT) will be performed preoperatively, immediate postoperatively, after abutment connection, after prosthetic rehabilitation, one year, three years and five years after loading to assess the long-term implant treatment outcome and the volumetric changes of the augmented area. The primary outcome will include survival of suprastructures, survival of implants, volumetric stability of the augmented area, peri-implant marginal bone level, oral health related quality of life, and complications related to the two treatment modalities.
The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the potential effect of bodily movement on early pre-reading and word recognition skills will be explored. The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.
People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability. The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period. If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.
The study is a randomized controlled trial studying the acute effect of intense aerobic exercise upon NK (Natural Killer) cell activation and appetite-regulation in human participants with or without concommitant IL-6R receptor blockade (Tocilizumab)
In the present study, patients with idiopathic pulmonary hypertension (IPAH) and chronic thromboembolic pulmonary hypertenion will be investigated in a randomized cross-over design with ketone infusions and placebo. Invasive and non-invasive hemodynamics will be evaluated
AMASS is a double-blinded randomized clinical trial with the purpose of investigating whether injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) results in increased ocular comfort compared to placebo.
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.