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.
To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.
Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group. Primary Outcome - Peyronie's Disease Questionnaire (PDQ) - Visual Analogue Scale score (VAS) - International Index of Erectile Function 5 (IEFF-5) - Penile curve measurements (gold standard) on pictures before and after treatment - Plaque size Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months. A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization. All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.
Introduction: Staphylococcus aureus bacteremia (SAB) plays an important role in long-course antibiotic therapy. Current international guidelines recommend fourteen days of intravenous antibiotic treatment for SAB in order to minimize risks of secondary deep infections and complications. However, patients with simple SAB are known to have a low risk of complications. Reducing treatment length in uncomplicated SAB would reduce the total consumption of antibiotics, adverse events and duration of hospital admission. SAB7 seeks to determine if seven days of antibiotic treatment in patients with uncomplicated SAB is non-inferior to fourteen days of treatment. Method: The study is designed as a randomized, non-blinded, non-inferiority interventional study. Primary measure of outcome will be failure to treatment or recurrence of SAB twelve weeks after termination of antibiotic treatment. As a measure of secondary outcome the prevalence of severe adverse effects will be evaluated, in particular secondary infection with Clostridium difficile, mortality as well as public health related costs. Patients identified with uncomplicated SAB, are randomized 1:1 in two parallel arms to seven or fourteen days of antimicrobial treatment, respectively. Endpoints will be tested with a statistical non-inferiority margin of 10%. Conclusion: SAB 7 will determine if seven days of antibiotic treatment in patients with uncomplicated SAB is sufficient and safe, potentially modifying current treatment recommendations.
The present study is testing in a combined design to types of drugs in patients with chronic heart failure: 1) Hydralazine in combination with isosorbide dinitrate (BiDil) and 2) Metformin hydrochloride. The study is double blind, placebo controlled. 1. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure. 2. The second hypothesis is that treatment of underlying insulin resistance/ type 2 diabetes with metformin in heart failure patients with moderately to severely reduced LVEF can reduce mortality and cardiovascular hospitalizations. Among secondary endpoints are reduction in new-onset diabetes in heart failure patients with insulin resistance and diabetes risk profile and patient safety.
To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate. To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.
A randomized, placebo-controlled, double-blinded cross-over study evaluating and quantifying the effect of pyridostigmine on muscle strength and symptoms in Myasthenia Gravis (MG)
The aim of this study is to validate and develop a new diagnostic and prognostic approach for assessment of liver function in children and adolescents with acute liver failure and chronic liver insufficiency. A carefully selected panel of functional and genomic tests along with diagnostic imaging and analysis of the microbiota will be performed in children and adolescents with acute liver failure and chronic liver insufficiency at Rigshospitalet. The tests will be performed in a serial manner in order to detect changes in outcomes. The study is an unblinded descriptive study, and approximately 20 patients with acute liver failure and 100 patients with chronic liver disease will be included in the project. This study will be the first of it's kind worldwide. The investigators expect the study to improve future diagnostic and prognostic accuracy and help the clinicians in identifying those patients in which the liver will regenerate itself, from those patients in which a liver transplantation will be lifesaving. Furthermore this study aims to help the clinicians in defining the optimal time for pediatric liver transplant in a narrow window of opportunity.
Primary central nervous system lymphomas are rare aggressive malignancies, usually treated in two steps: an induction phase (where a combination of chemotherapy is given) followed by a consolidation phase (where patients usually receive one of the following: whole-brain irradiation, chemotherapy supported by autologous stem-cell transplantation, other type of chemotherapy, or are just observed). The feasibility of this overall strategy, for several reasons, is limited in elderly patients . This study involves patients aged ≥70 years. The more fit patients will receive the standard chemotherapy combination (high-dose methotrexate, procarbazine and rituximab) as induction. Responding patients will receive either procarbazine or lenalidomide as maintenance therapy; the aim is to evaluate the efficacy of these two drugs. The more fragile patients will receive a less aggressive therapy consisting of concomitant whole-brain radiotherapy, temozolomide and rituximab as induction therapy, followed by temozolomide as maintenance treatment; the aim is to evaluate the efficacy of this combination of treatment.