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.
When aortic valve-area is <1.0cm2 and transvalvular mean-gradient is >40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient <40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). When a patient with LFLG AS also presents with LVEF <50%, guidelines recommends performing a Low-Dose Dobutamine-echocardiography (LDDE) to confirm true-severe AS. However, nearly 30% of patients with LFLG AS do not show an adequate respond to Dobutamine. More commonly, patients present with the combination of LFLG AS, despite LVEF≥50%. In this group of patients the use of LDDE remains undisclosed. The purpose of this study is to examine the safety and diagnostic usefulness of LDDE in patients with LFLG AS with LVEF≥50%. Furthermore we will examine factors associated with inadequate response to LDDE. 150 symptomatic and/or asymptomatic patients with LFLG and LVEF≥50% and a control group with LVEF<50% will be enrolled at the Department of Cardiology, OUH. Patients will undergo clinical evaluation including LDDE, blood analyses, CT-scan and cardiac Mri. Only a limited number of studies examine the possible use of LDDE in patients with LFLG AS and LVEF≥50% and no study has been performed documenting the safety and feasibility.
A large proportion of concussion patients with long-term consequences of concussion experience visually related symptoms such as headache, blurred vision, double vision, and fatigue. These patients often have difficulties coordinating the movement of the two eyes (convergence insufficiency) which is essential for single and clear vision to be obtained and is hence a likely explanation for the symptoms. 100 patients with long-term symptoms of concussion and convergence insufficiency will be offered either exercises or placebo treatment the evaluate the effect of exercises aimed at improving coordination between the two eyes. The study will provide data to support clinicians in deciding whether to use exercises or not as a treatment of symptoms for patients with convergence insufficiency as a long-term consequence of concussion.
Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines. The aim of this study is to evaluate the feasibility a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program. An intervention consisting of action planning, text messages, and coordinator support is tested in a feasibility trial design with 40 expected participants.
Epidemiological studies have revealed that 60-80% of women with breast cancer (BC) develop metabolic disorders that are similar to those observed in conditions like type 2 diabetes. These metabolic disorders, including insulin resistance, obesity, hyperinsulinemia, and glucose intolerance, are associated with increased BC recurrence and mortality. Skeletal muscle is the major site of glucose uptake in humans. The aims of the present project are to 1) determine the involvement of insulin resistance in skeletal muscle in the metabolic disorders prevalent in BC survivors, 2) identify BC-and/or treatment-induced molecular changes in skeletal muscle from BC survivors .
Cataract surgery is the most common eye surgery in the world. If the patient with cataract uses spectacles and both patient and surgeon find it beneficial, it is possible to compensate for the spectacles during surgery and thereby obtain a spectacle-free distance vision or spectacle-free near vision. Becoming spectacle free increases quality of life substantially and is one of the primary wishes in cataract patients. Socioeconomically, spectacle free life is beneficial as it reduces fall tendency in the elderly population. Multifocal lenses warrant the possibility of obtaining a spectacle free vision at near, intermediate and distance. It is also possible to obtain spectacle free distance and near vision or distance and intermediate vision by using traditional artificial monofocal lenses but making one eye spectacle free for distance and the other eye spectacle free for near or intermediate vision. Currently, it is not know which procedure is most beneficial for cataract patients. In a recent PhD, the investigators developed a method, Aniseikonia Tolerance Range (ATR), that can assess how much refractive change a patient can endure without impairing stereopsis. The results demonstrated large variation in the tolerance of image difference. This method can be a future tool to assess whether a patient can tolerate the refraction that is considered most beneficial to the patient. The knowledge is important as it can help avoid improper lens choice in cataract surgery and thereby avoid stereopsis problems.
This project has focus on patients in palliation testing a digital platform TelePal.dk.
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
The pilot study is a single-blinded, randomized, controlled, 2 months clinical trial. The objective is to investigate the feasibility, effects and side-effects of virtual reality-assisted cognitive behavioral therapy (VR-CBT) vs. cognitive behavioral therapy (CBT) on alcohol intake in patients with a diagnosis of alcohol dependence.
Aims and Hypotheses Aims - to investigate associations between an intelligent exercise training intervention and clinical health parameters, well-being, sick leave and productivity at Nordsjællands Hospital (NOH) - to generate data and experiences to a larger cluster randomized trial with more included departments at NOH - to analyze how the intervention could be successfully implemented in the organization to ensure long-term effects Outcomes - Aerobic capacity (Åstrand's ergometer test) - Blood pressure and heart rate - Physical activity (steps measured by tracker) - Self-reported health (questionnaire EQ-5D) - Self-reported physical activity (questionnaire IPAQ) - Well-being (questions from the Danish Health and Morbidity Survey) - Musculoskeletal pain and use of anti-pain medications (Numeric Rating Scale) - Monetized value of productivity loss - Productivity using an employer´s perspective (scale 1-10) - Sick leave (days in short term (≤14 days) and long term (>14 days), data will be delivered by The Department of HR) - Muscle strength in knee extension (dynamometer) Intervention The concept of intelligent training at the worksite is an individualized exercise training where the exercises are: 1) balanced to the physiological capacity of the employees relative to their occupational exposure, 2) tailored to the individual capacities and disorders to improve employees' health, 3) motivating by offering evidence based and enjoyable programs implemented with care, and 4) cost-effective for the company. The intervention period is 20 weeks of intelligent exercise training. Every week, several exercise sessions will be offered to the participants in the intervention group during the working hours. The exercise sessions will be of 30 min durations twice a week and include aerobic exercise with high intensity (≥16 on the Borg scale, rate of perceived exhaustion), resistance training and/or functional training. In addition, there will be a number of intelligent exercise sessions of 30 min durations before and after the most common working hours with a primary focus on aerobic exercise. The exercise sessions will be supervised by exercise experts (education in sport or physiotherapy). The intelligent exercise interventions will be adjusted to the individual participant's physical capacity and limitations; thus, as one participant may perform aerobic exercise, another person may perform resistance training.
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.