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.
This study compares two blood pressure targets and two oxygenation targets in the post-resuscitation care of comatose out-of-hospital cardiac arrets patients. Using a novel method the blood pressure-intervention is double-blinded. The oxygenation-intervention is open-label. As a subordinate study, the patients will be randomized 1:1 to active fever-control with an automated feedback temperature control-device for 36 or 72 hours following return of spontaneous circulation.
The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells
To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.
This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups. The first group will enroll HV into a single ascending dose (SAD) treatment group consisting of three cohorts. The second group will enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts. The third group will enroll HV into a food effect (FE) treatment group consisting of one cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group consisting of one cohort. Approximately 76 subjects will be enrolled in Part 1. Part 2 Cohorts 1 through 3 will enroll adult subjects with cystic fibrosis (CF) currently on stable ivacaftor/lumacaftor background therapy for a minimum of three months. Part 2 Cohorts 4 and Cohort 5 will enroll adult subjects with CF not currently receiving cystic fibrosis conductance regulator (CFTR) modulator therapy within 30 days prior to Day 1. Part 2 Cohort 6 will enroll adult subjects with cystic fibrosis on stable tezacaftor/ivacaftor background therapy. Approximately 104 subjects will be enrolled in Part 2.
This is a randomized, controlled study which aims to show whether iodine impregnated incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI). 1200 patients will be included in this study and will be followed through out a ten year period. Follow up will center on the function of the prosthetic knee, early and late infection rates and revision surgery due to aseptic loosening. Our purpose is to gain insight in to the causes of post-operative infection in joint alloplasty surgery. Our hypothesis' are: 1. The patient's skin flora is the main source of intraoperative contamination, 2. Intraoperative contamination can be reduced by using IobanTM 3. Intraoperative contamination strongly predicts postoperative infection 4. Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections. To our knowledge this is the first study with this large a sample size and as long a follow up. Background PJI is a devastating complication with substantial morbidity and high socio economic costs. Revision surgery due to infection costs as much as six times more than the primary surgery and has a poorer outcome for the patient i.e. disability, pain or loss of function. Methods and materials The study has two main arms: 1. Intraoperative contamination 2. Postoperative infection The first stage aims to document that patients with intraoperative contamination have a larger risk of developing postoperative infection and include a study of the effect of Ioban™. The second stage are to include methods of PCR (polymerase chain reaction) and fluorescence microscopy, to demonstrate bacterial contamination and/or infection of any implants removed during the study period. Perspectives This study will give us new insight in the causes of PJI and the correlation with contamination during surgery. If IobanTM is proved to prevent infection it is a simple way to prevent post-operative infection and can be implemented in any orthopedic department.
The purpose of this study is to investigate and describe the anatomical differences in distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in healthy volunteers, as a blinded, randomized, paired trial.
The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and efficacy of MP0250 in combination with bortezomib + dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM). MP0250 is a multi-DARPin® drug candidate with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
The primary purpose of this study is to determine the prevalence of adrenal insufficiency in a population of patients with kidney transplants receiving low dose prednisone treatment. Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to glucocorticoid treatment. The study includes a control group of patients with kidney failure currently treated in dialysis, who are not in glucocorticoid treatment. Individual genotyping is performed to determine the haplotype of glucocorticoid receptor polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid receptor gene will either have increased or diminished glucocorticoid sensitivity. Using validated questionnaires assessing the quality of life and functional level of the patients enrolled in the study we aim to establish a link between functional level and biochemically proven adrenal insufficiency. Other secondary outcomes in the study includes bloodpressure, body composition, bone density, metabolic syndrome, inflammation and salivary cortisol profiles.
The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres induces greater changes in body weight compared to placebo during 12 weeks of energy restriction in an obese/overweight population. The hypothesis is that the fiber-containing dietary supplement will: 1) Induce greater changes in body weight compared to the placebo group 2) change the gut microbiota composition 3) improve glucose homeostasis 4) decrease serum concentration of triglycerides, total and LDL cholesterol The hypothesis is that the effect of the intervention on weight loss will be partly mediated by the diet-induced changes in the gut microbiota composition.