Clinical trials

The primary aim of this study is to evaluate changes in absolute coronary flow and pressure before and after percutaneous coronary intervention in calcified lesions. The secondary aim is to use a machine learning model to predict the outcome of the intervention.

Worldwide infertility is highly prevalent and lifestyle factors, such as food intake, could have an essential role in the success of a fertility treatment. The literature is not consistent and adequate for recommendations to the increasing number of women and men of reproductive age who ask for lifestyle guidance. Therefore, the aims of the Food \& Fertility study will be to investigate the association between food intake and semen quality, pregnancy- and live birth rates in women and men undergoing assisted reproductive technology (ART) treatment.

When patients undergo major surgery, they are connected to a ventilator during anesthesia. A heat and moisture exchange filter (HME filter) is routinely placed in the ventilator tubing to ensure that the inhaled air is warm and humidified. Today, HME filters are used routinely in all ventilator treatments. They are typically replaced once a day and discarded as regular waste after use. The purpose of this study is to investigate whether HME filters contain proteins and small biological particles from the patient's exhaled air.

The goal of this observational study is to learn why some patients develop low anterior resection syndrome (LARS) after colorectal cancer treatment. The study also aims to identify different subtypes of LARS and understand which patients may respond to specific treatments. The main questions it aims to answer are: * What physiological and imaging changes are associated with LARS? * How do patients with LARS differ from patients without LARS after colorectal cancer surgery? * Are there measurable differences between LARS, patients treated with organ-preserving chemoradiotherapy, and patients with fecal incontinence? Participants will: * Complete advanced physiological and imaging assessments related to bowel function * Be compared with four control groups: * patients without LARS after colorectal cancer surgery * patients treated with organ-preserving chemoradiotherapy * patients with fecal incontinence and urge fecal incontinence * Take part in a single study visit where all measurements are performed

The trial utilizes a pragmatic, randomized, open label design with two parallel arms. Participants aged 18-65 with a diagnosis of unipolar depressive disorder and without stable remission in the past 12 months are randomized 1:1 to receive either algorithm guided treatment (AGT) or treatment as usual (TAU). The AGT approach incorporates pre-defined treatment steps, critical decision points, and "if-then" rules based on symptom response. It leverages prior treatment history, current symptomatology, and tolerability profiles to personalize the therapeutic sequence and reduce treatment inertia. In contrast, TAU reflects standard clinical practice, where treatment decisions are left to clinician discretion without algorithmic structure. The primary objective of the study is to determine whether AGT leads to a greater reduction in depressive symptoms over a 12-week treatment period, as measured by the 6-item Hamilton Depression Rating Scale (HAMD-6). Secondary objectives include evaluating cognitive and psychosocial functioning, suicide risk, treatment adherence, tolerability, number of medication changes, and long-term outcomes at a 24-week follow-up, providing insights into the longer-term trajectory of TRD management.

The aim of this study is to investigate whether the voided urinary, perineal/preputial, and the fecal microbiota are different between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the study aims to investigate if the microbiota is different according to the severity of DUI and if the microbiota is changed throughout treatment of DUI. A follow-up study will as well be performed on healthy children to investigate how the microbiota evolves with increasing age and pubertal stage. Children with OAB and DUI will be recruited from involved pediatric departments, and specimen in the form of urine, perineal/preputial swabs, and feces will be collected according to the protocol.

The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.

The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach. Participants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated. Primary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation. This trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.

The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for three months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.

The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease. The main question it aims to answer is: Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6) Participants will be randomized to treatment with either lithium or cariprazin. * Will meet for interview and ratings 4 times during study period. * In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample. * Will be contacted for telephone interviews at 6 occasions.

The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years. We wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial. The participants will be randomised to one of the following three treatments: 1. Standard treatment provided by a general practitioner (i.e. the general practitioner treats the patient as he/she would normally do, when treating a patient with depression). 2. Standard treatment provided by a psychologist in the form behavioural therapy (i.e. the psychologist treats the patient as he/she would normally do, when treating a patient with depression). 3. A step-by-step treatment plan carried out by a general practitioner. The plan includes pre-determined follow-ups and a pre-determined, structured plan for which medications to use and when to increase dose or switch medication. The hypothesis is that a structured and step-by-step treatment approach regarding patients with depression, treated in general practice, is more effective than standard treatment provided by a general practitioner and a psychologist. All the participants will: 1. Receive one of the three treatments for 12 weeks. 2. Have meetings with the project staff every 4 weeks (week 0, 4, 8 and 12) were rating scales will be completed, e.g. a rating scale to measure progress or deterioration in the participant's depression.

Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH. The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years. Ethics approval for inclusion of competent patients has been obtained (N-20240009).

A low plasma level of mannose binding lectin (p-MBL) is associated with unexplained recurrent pregnancy loss (RPL), but it is not investigated if it is associated with unexplained reproductive failure in general, including recurrent implantation failure (RIF) after assisted reproductive technology (ART) (including IVF, ICSI and FET), recurrent pregnancy loss (RPL) after spontaneous conception, and RPL after ART.

The primary aim of this clinical study, 'Dual Energy CT - a tool for delineation of tumor and organs at risk in radiotherapy' (DART) is to evaluate whether dual-energy CT (DECT) is at least as effective as magnetic resonance imaging (MRI) in delineating both tumors and organs at risk (OARs) in patients referred for radiotherapy (RT). This primary aim will be explored in patient groups where the performance of DECT for RT has been described in the literature (but mostly based on signal-to-noise ratio and/or contrast-to-noise ratio), such as brain metastases (sub-cohort 'DART Brain') and head and neck cancer (sub-cohort 'DART H\&N'). Additionally, DART will explore diagnoses not yet studied in the literature, such as bone metastases (sub-cohort 'DART Bone'). If DECT could be demonstrated to achieve delineations for RT in both tumors and OARs that are equally accurate as those based on MRI, it could offer significant advantages by being faster and more cost-effective, making DECT a valuable alternative to MRI in clinical practice. As a secondary aim, the study will evaluate whether DART offers benefits when added to standard RT imaging for tumor and OAR delineation: (1) For lung cancer patients (sub-cohort 'DART Lung'), where MRI scans are typically not valuable due to tumor motion caused by breathing, 'DART Lung' will assess whether DECT performed in breath-hold provides added value compared to the single-energy CT (SECT) scan conducted during free breathing, as used in current clinical practice. (2) For head and neck cancer patients, 'DART H\&N' will evaluate whether DECT offers added value compared to the positron emission tomography (PET)/CT scan currently used in clinical practice.

This study investigates the anticholinergic burden on patients seen in the Subacute mobile outpatient geriatric clinic in Aalborg, Denmark, between the years of 2024 and 2025. The age demographic in Denmark and multiple other countries is changing rapidly, with more old and very old individuals as a result. As humans become older, they tend to accumulate more illnesses, and the risk of polypharmacy increases. There is a wide selection of medicine that affect the binding of acetylcholine to the muscarinic receptors, which is either the intended function of the pharmacological product or a side effect. Since there is no built-in feature in computer systems used by doctors to calculate the cumulative anticholinergic burden, it is often not recognized, thus not reflected upon. This raises concerns about potential central and peripheral side effects, such as altered mental status, visual disturbances, tachycardia, urinary and fecal retention, dry skin etc. The study aims to determine the prevalence of anticholinergics in the last 100 patients seen by the Subacute mobile outpatient geriatric clinic in Aalborg University Hospital. The patients are placed in municipal extended-care facilities. Furthermore, the study will investigate the prevalence of anticholinergic side effects concerning the burden on this population. The study is a retrospective chart review of patient charts from the years of 2024 and 2025, analyzing patient characteristics, comorbidities, medication lists, and calculating the anticholinergic burden through the ACB calculator.

The aim of this study is to investigate whether the quality of physiotherapy follow-up after spinal surgery can be maintained when conducted by telephone rather than in-person. The study is motivated by the desire to save healthcare resources and reduce the environmental impact of patient travel. Data from patient records, including age, sex, surgery procedure, use of pain medication, and time spent on either phone or in-person follow-ups, will be collected to evaluate whether telephone-based follow-up is an effective and sustainable alternative for post-operative care.

Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT). The diagnostic accuracy will be determined with histopathology as reference standard. For patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET/CT and an additional FDG PET/CT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET/CT in response evaluation will be investigated. All study specific analyzes will be blinded and will not influence the patient management / treatment.

Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary embolism (PE) is the third most frequent cardiovascular disease and is associated with substantial short- and long-term morbidity and mortality and high costs of care. In addition negative physical and mental complications following VTE are common. However in terms of PE, there are no structured follow-up programs in Denmark and there is considerable variation in practice patterns of post-PE management both within and between countries. This project aims to develop, test and implement a structured follow-up care model for patients with PE (The Attend-PE model). This project is a pre-post intervention study and will estimate the effectiveness of implementing the structured follow-up care model on a national level.

The goal of this observational study is to investigate the potential of wearable sensors for monitoring the postoperative recovery of patients after TKA. The main question the study aims to answer is: • whether alterations in gait characteristics and the changes in PA levels measured by wearable PA trackers can accurately reflect a patient's postoperative recovery status and provide clinically relevant information to aid their management. Participants will wear PA trackers during the perioperative period of TKA (2 weeks before until 3 months after, and then agin for 2 weeks one year after the surgery) and we will analyze their gait and PA and correlate them with their recovery after surgery.

This randomized controlled trial investigates the effectiveness and safety of the Optilume® drug-coated balloon (DCB) compared to standard direct visual internal urethrotomy (DVIU) in the treatment of bulbar urethral strictures. The primary objective is to assess freedom from repeat intervention at 12 months. Secondary objectives include evaluating urethral patency, urinary symptoms, and sexual function through objective measures (Qmax, PVR, cystoscopy) and patient-reported outcomes (USS-PROM, IPSS, IIEF-5). The study will recruit 140 participants across multiple sites, with follow-ups conducted at 6 and 12 months. This trial seeks to provide evidence for Optilume DCB as a safe and effective alternative to standard treatment.

In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas. With this study the investigators aim to validate these findings in a larger cohort.

The investigators aim to elucidate characteristics of structural and functional brain connectivity in patients with amyotrophic lateral sclerosis (ALS) and pseudobulbar affect (PBA) using diffusion kurtosis imaging (DKI) and magnetoencephalography (MEG).

The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.

This randomised controlled trial (RCT) aims to investigate the effect of long-term, interactive home-based cycle-exercise on patients with Chronic Obstructive Pulmonary Disease (COPD) after a COPD exacerbation requiring hospitalisation. The investigators aim to investigate if patients can maintain or improve the effects of pulmonary rehabilitation in terms of walking distance, intensity of COPD symptoms, health related quality of life and Quality Adjusted Life-Years. Participants will cycle on a pedal-exerciser in the comfort of staying in the participants' own home, whilst getting visual feedback from the 4Mvideo app. The 4Mvideo technology is a Danish designed software system, where users can cycle forward a recording of a cyclist by treading on a pedal-exerciser, thereby getting some of the experience of a real-life cycling trip at home. The investigators will compare the clinical outcomes and daily activity levels with that of a control group consisting of COPD patients.

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.