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.
Fifty (n=50) patients with newly diagnosed ovarian cancer will undergo FAPI PET/CTs in addition to routine diagnostic workup (including FDG PET/CT) at primary staging and restaging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: - medical problems (also called treatment-emergent adverse events (TEAEs)) - serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important - higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times. The study team will: - collect blood and urine samples - check the participants' vital signs such as blood pressure and heart rate - do a physical examination including height and weight - check the participants' heart health by using an electrocardiogram (ECG) - do pregnancy tests in women of childbearing potential
Surgery is a key element in the treatment of melanoma, and naturally linked with an inflammatory response and recruitment of innate immune cells. Although surgery has a favorable intent, surgery-induced inflammation, neutrophils in particular, may accelerate growth of local and systemic micrometastases. Thus, improving cancer surgery and modulating the wound microenvironment in ways that benefit the patients is crucial. Repurposing already approved drugs in a cancer setting has gained increasing interest in recent years. Interestingly, tranexamic acid was recently suggested as an anti-cancer drug, capable of reducing tumor growth in experimental animal models and reducing the viability of different melanoma cell lines. As a novel approach, sponsor and investigators will conduct a Randomised Clinical Trial, using perioperative treatment with Tranexamic Acid, aiming to prevent the early relapses for patients with melanoma.
Twenty (n=20) patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PET/CTs in addition to routing diagnostic workup (including FDG PET/CT) at primary staging and restaging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.
The purpose of this trial is to investigate the feasibility and safety of implementing a protocol-based treatment aggressively targeting albuminuria in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria. If this approach is feasible, the results of the trial will inform the design of a large-scale randomized clinical trial to evaluate the effect of this treatment on hard kidney endpoints (initiation of dialysis, kidney transplantation, and death from kidney failure) in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria.
The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.
After resuscitation from Out-of-Hospital Cardiac Arrest (OHCA) patients experience Post Cardiac Arrest Syndrome due to ischemia and reperfusion injury. It consists of systemic inflammation, cerebral and myocardial dysfunction, and the condition that led to the arrest. Most OHCA patients will receive critical care intubated in an Intensive Care Unit (ICU). Despite this ~50% die; mainly due to brain injury. Several targets can be considered for improving outcomes. To dampen systemic inflammation and optimize cerebral perfusion seem important. Deep sedation has been required for targeted temperature management (TTM) but may also be brain protective. After end of sedation, many patients have some cerebral dysfunction that may facilitate delirium. The aim of this trial is therefore to improve treatment of comatose OHCA patients by evaluating 4 interventions in a factorial design addressing each of these targets in a randomized clinical trial: 1. Systemic inflammation: Anti-inflammatory treatment with high dose steroids (dexamethasone) or placebo. 2. Cerebral perfusion: Backrest elevation during sedation at 5 or 35 degrees. 3. Duration of sedation: Early wakeup call and potential extubation at ≤6 hours after admission or later as current standard practice at 28-36 hours. 4. Delirium: Prophylactic treatment with anti-psychotic medication (olanzapine) or placebo. The trial is designed as a phase III trial, randomizing 1000 patients at Danish cardiac arrest centers. The primary endpoint is 90 days all-cause mortality for the interventions targeting systemic inflammation and cerebral perfusion, while it is days alive outside of hospital within 30 days for the interventions concerning duration of sedation and delirium. The trial has potential to improve outcomes for comatose OHCA patients - a group with a grave prognosis with currently only limited evidence-based treatments.
This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI>30 kg/m2). Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26. The primary endpoint is the percentage-point reduction in total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.
Development of work-related musculoskeletal disorders (WMSDs) is a common issue within logistics manual materials handling which is associated with the high physical demands of the workers. Especially back injuries are highly represented among manual workers in logistics. Occupational exoskeletons are seen as a solution to this issue, as it has shown to reduce the muscle activity during several manual handling tasks within manufacturing, construction work, mechanics, and logistics. However, there is a major gap in scientific literature on studies investigating in-field effects of exoskeleton-use on longer terms, which means that we in general have very little knowledge on the pros and cons of implementing exoskeletons in the product-line of logistics. Consequently, our current understanding of how a back-supporting occupational exoskeleton can benefit the manual workers of a logistics company is limited. The purpose of this study is to investigate (i) the long-term effects of a passive back-exoskeleton during manual materials handling on the biomechanics of the user, (ii) the changes in comfort, well-being and productivity pre and post to implementation of passive back-exoskeleton. It is hypothesized that exoskeleton-use will maintain a reduction in muscle activity of the manual workers and increase their overall well-being without affecting their productivity.