Clinical trials

* To determine the incidence of arterial inflow problems and venous outflow problems as causes of impaired renal function and/or treatment-resistant hypertension after kidney transplantation, when all kidney-transplant recipients in Denmark are evaluated according to uniform, well-defined clinical criteria. * To investigate the efficacy and safety of catheter-based balloon treatment (percutaneous transluminal angioplasty, PTA) for these vascular complications, of which transplant renal artery stenosis is by far the most common. * To assess whether novel imaging and functional diagnostic methods can predict treatment response.

This study is a randomized, double-blinded, placebo-controlled trial investigating the effects of zoledronic acid (ZOL) versus placebo in patients with primary hyperparathyroidism (PHPT) undergoing parathyroidectomy (PTX). PHPT is a common endocrine disorder associated with hypercalcemia, reduced bone mineral density (BMD), increased fracture risk, renal calcifications, and cardiovascular complications. While PTX remains the definitive treatment, the potential role of bisphosphonates in optimizing post-surgical outcomes remains unclear. This trial aims to evaluate whether a single infusion of ZOL prior to PTX impacts bone health, cardiovascular parameters, and renal function one year post-surgery. The primary endpoint is the change in areal bone mineral density (aBMD) at the lumbar spine one year after PTX. Secondary endpoints include changes in aBMD at other skeletal sites, volumetric BMD, bone microarchitecture, bone turnover markers, coronary artery calcium score, arterial stiffness, and renal calcifications. A total of 140 postmenopausal women and men over 50 years with PHPT and low BMD will be enrolled and randomized to receive either ZOL or placebo 2-4 weeks before PTX. Participants will undergo extensive imaging, biochemical analysis, and cardiovascular assessments at baseline and one year post-surgery. This study seeks to clarify whether ZOL improves post-surgical bone recovery or interferes with the natural bone remodeling process following PTX. Additionally, it will provide insight into the cardiovascular and renal effects of bisphosphonate therapy in PHPT patients. Findings may help guide treatment strategies for optimizing long-term skeletal and systemic health in this patient population.

The goal of this clinical trial is to learn if adding an abdominal ultrasound scan to the standard examination helps emergency physicians make a correct diagnosis in adults with acute abdominal pain in the emergency department. The main question it aims to answer is: Does adding an abdominal point of care ultrasound scan to the standard examination increase the number of patients with acute abdominal pain in the emergency department, who get a correct preliminary diagnosis? Researchers will compare patients examined with an abdominal point-of-care ultrasound scan in addition to the standard examination to patients examined with the standard examination alone, to see if adding ultrasound improves diagnostic accuracy. Participants will: * Be randomly assigned to also have an abdominal point-of-care ultrasound scan performed by their doctor, or not * Have their doctor record a preliminary diagnosis and differential diagnosis * Have their medical records reviewed by an independent panel 30 days after their visit, to determine their final diagnosis

Parents of children and adolescents with mental health problems may experience substantial caregiving burden and emotional distress, including persistent stress, self-criticism, shame, and parental burnout. Hand in Hand is a four-week, self-guided, compassion-focused app developed to support parents of children and adolescents referred to Child and Adolescent Mental Health Services (CAMHS). Drawing on principles from Compassion Focused Therapy (CFT) and inspired by work by Kirby et al., the app was developed through a participatory co-design process involving parents and clinical and research experts. The project comprises two interrelated sub-studies. Sub-study 1 is an open feasibility study evaluating the feasibility and preliminary outcomes of Hand in Hand among parents of children and adolescents referred to CAMHS in the Central Denmark Region. Feasibility outcomes include recruitment, retention, adherence, engagement, acceptability, and data completeness. Preliminary changes in parental outcomes, including parental burnout, emotion regulation, family empowerment, self-compassion, self-criticism, shame, and emotional distress, as well as parent-reported child outcomes, will also be explored. Sub-study 2 is an embedded qualitative study exploring parents' experiences of using Hand in Hand and their perceptions of whether and how the intervention influences parental well-being and family interactions.

The goal of this randomised controlled trial is to evaluate whether a partially supervised, home-based exercise programme in addition to usual care improves health-related quality of life in adults with systemic sclerosis. The main questions it aims to answer are: 1. Does a partially supervised, home-based exercise programme improve health-related quality of life, measured by the EQ-5D-5L, compared with usual care alone after 6 months? 2. Is the partially supervised, home-based exercise programme cost-effective compared with usual care over a 12-month period? Researchers will compare the partially supervised, home-based exercise programme plus usual care with usual care alone to determine whether the partially supervised, home-based exercise programme improves health-related quality of life, disease impact, physical function, physical activity, and represents a cost-effective treatment strategy. Participants will: * Be randomly assigned to either the partially supervised, home-based exercise programme plus usual care or usual care alone. * Complete questionnaires at baseline and after 3, 6, 9, and 12 months. * Undergo physical function assessments at baseline and after 6 months. * If allocated to the intervention group, perform a 24-week home-based exercise programme consisting of three weekly sessions of aerobic and resistance exercise, supported by six online physiotherapist consultations, followed by 28 weeks of self-guided exercise. * Complete follow-up assessments of healthcare utilization, productivity, adherence, and adverse events throughout the 12-month study period.

In summary, there is a compelling rationale for investigating venetoclax as an intervention to sensitise virus-expressing cells to apoptosis and thereby reduce the size of the latent HIV reservoir. While this concept may ultimately need to be tested in the setting of concomitant latency reversal, the investigators propose to initially establish the safety of venetoclax in PLWH on ART. The investigators will use this study to also investigate effects of venetoclax monotherapy on proapoptotic pathways, immune effector function and HIV persistence in PLWH on ART and through these studies establish the rationale for subsequent studies testing venetoclax in combination with an LRA.

This is a multicenter randomized controlled trial including patients with small (\<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment. The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.

The purpose of this randomized feasibility study is to examine whether the COMFORT intervention is feasible and acceptable for adults with advanced kidney disease and their informal caregivers. People with advanced kidney disease often experience several symptoms, such as fatigue, itching, pain, and sleep-related problems. These symptoms can affect daily life and quality of life and may also place a burden on family members and other informal caregivers. The COMFORT intervention is a nurse-led programme designed to help patients and their informal caregivers recognise and manage symptoms. A total of 56 adults with advanced kidney disease will be randomly assigned to one of two groups. One group will receive usual care. The other group will receive usual care plus the COMFORT intervention over approximately 3 months. The intervention includes systematic assessment of symptoms, a symptom management decision-support tool, shared decision-making, support for self-management, and involvement and support of informal caregivers. It is delivered by trained nephrology nurses through two structured consultations and one follow-up telephone consultation. The study will examine whether patients can be successfully recruited and retained, whether the intervention can be delivered as planned, whether patients, informal caregivers, and nurses find the intervention acceptable, and whether the study procedures and questionnaires are suitable for use in a future larger trial. The study is not designed to determine whether the COMFORT intervention is clinically effective.

This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.

The goal of this study is to evaluate the effectiveness and assess the implementation of CROSS-MIND, a school-based mental well-being intervention for adolescents in Nepal. The study uses a Hybrid Type 1 mixed-methods design. The main questions it aims to answer are: Does CROSS-MIND improve students' mental well-being, self-esteem, and behavioural and emotional outcomes compared with usual school activities? Is CROSS-MIND acceptable, feasible, appropriate, and delivered with adequate fidelity, and what barriers and facilitators influence its delivery by teachers? For the effectiveness evaluation, classes of grades 6 to 10 in five schools in Bharatpur Metropolitan City will be randomly assigned to receive either the CROSS-MIND intervention or usual school activities. Students will complete questionnaires before and after the intervention. Students in intervention classes will participate in eight weekly storytelling and reflection sessions of approximately 90 minutes, delivered by trained teachers. Qualitative interviews and focus group discussions will also be conducted with selected students, teachers, school principals, and psychologists to explore experiences of the intervention and factors influencing its implementation.

This study aims to evaluate the feasibility and acceptability of the Conquer Fear Carer Brief, a three-session psychological intervention targeting fear of cancer progression among caregivers of patients with metastatic prostate cancer.

Giant Cell Arteritis (GCA) is a vasculitis of medium- and large-sized arteries in older adults that may lead to serious vascular complications, including permanent vision loss and aortic aneurysm formation. Glucocorticoids are effective, but relapse during tapering is common and poses a major clinical challenge, potentially contributing to prolonged glucocorticoid exposure. Symptoms are often nonspecific and conventional inflammatory markers lack sufficient reliability, particularly in patients treated with drugs targeting the interleukin-6 pathway. Thus, this project aims to evaluate different tools assisting disease activity monitoring and/or predict future relapses and higher treatment requirements. Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up. Participants undergo vascular ultrasonography, including double-blinded assessment at suspected relapse, complete patient-reported outcome measures, and provide biobank blood samples.

This Ph.D. project investigates whether orally ingested galactose can be taken up by skeletal muscle and the heart in response to exercise or hyperinsulinemia, and whether it may serve as a viable nutritional strategy for individuals with type 1 diabetes (T1D). Although exercise provides significant health benefits for people with T1D, it is often associated with substantial glucose fluctuations and an increased risk of hypoglycemia. Conventional carbohydrate strategies based on glucose may further exacerbate glycemic instability due to the rapid increase in blood glucose levels. In contrast, galactose is metabolized more slowly and may therefore provide a more stable energy source during and after exercise. Previous research has demonstrated that intravenously administered galactose is taken up by human skeletal muscle, with uptake increasing during exercise, suggesting a mechanism that may be at least partly insulin-independent. Building on these findings, this project aims to determine whether similar uptake occurs when galactose is ingested orally. This study uses a randomized controlled design and applies non-invasive 18F-FDGal PET imaging to quantify galactose uptake in skeletal muscle and cardiac tissue. The findings may contribute to improving dietary recommendations for individuals with T1D, particularly in relation to maintaining stable blood glucose levels during and after physical activity.

In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and consultation quality. Yet, little is known about the effect of using PROs in type 2 diabetes (T2D) care in general practice. This project, PRODIAP (Patient-reported outcomes in general practice among people with type 2 diabetes) aims to investigate whether the use of a diabetes-specific PRO questionnaire can improve care quality and support more individualised consultations for people with T2D. PRODIAP is tailored to general practice, adapted from hospital PRO tools, and pilot testing showed promising feasibility and acceptability. This project applies a mixed-methods design with two sub-studies: 1. A pragmatic, cluster-randomised controlled trial in 30 general practices (N≈2000 patients) evaluating PRODIAP's effect on perceived care quality with patient perceived quality of care (PACIC) as primary outcome. 2. A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives. The project group has established a national collaboration with general practitioners, researchers and stakeholders from all five Danish region, supporting the feasibility of this study. Findings are expected to improve diabetes care in general practice and inform management of other chronic conditions. Findings are expected to improve diabetes care in general practice and provide transferable knowledge for other chronic conditions.

The goal of this clinical trial is to gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are: Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care. * Either in the initial 1-12 weeks after Achilles tendon rupture, or * In the following 13-24 weeks after Achilles tendon rupture Researchers will compare the two groups at 13 weeks (3 months) to compare BFRE to usual care, and at 25 weeks (6 months) to compare the two time points for initiating BFRE (early vs. late).

The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. In addition, the study will investigate whether the gel promotes regression of CIN1/CIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome. The primary outcomes therefore is: • hrHPV clearance from baseline to follow-up (6 months) In this randomized controlled study, eligible participants will be randomized 1:1 into two groups: 1. Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle). 2. Control group; Women (n=35) will follow the conventional "wait and see" approach.

Cervical cancer is the fourth most common cancer in women worldwide. It is caused by an infection with human papillomavirus (HPV). A persistent infection with HPV is associated with increased risk of precancerous lesions, which may further develop into cervical cancer. To reduce the disease burden, accurate and timely diagnosis of cervical precancerous lesions are crucial. To identify cervical precancerous lesions, women are referred to colposcopy, which is the most important diagnostic tools to detect cervical precancerous lesions. It allows close visualization of the cervix in order to collect biopsies in the area called transformation zone (TZ), which is where precancerous lesions develop. It is essential for the physician to identify the TZ during colposcopy in order to obtain correct diagnosis. For women aged ≥50 this is often a challenge as TZ naturally with age, will retract further into the cervical canal, making the area for sampling invisible, and thereby the colposcopy inadequate. Consequently, this increases the risk of developing cancer due to diagnostic delay, and the risk of several colposcopy examinations or overtreatment (cone biopsy), before a final diagnosis is achieved. Few studies suggest that pretreatment with local vaginal estrogen prior to colposcopy may improve visualization of the TZ. Thereby, obtaining more accurate biopsies from the cervix, and thus making a more accurate and timely diagnosis in the first outpatient visit. The primary purpose of this study is to evaluate pre-diagnostic treatment with estrogen to improve the diagnosis of women with cervical precancerous lesions, in order to prevent cervical cancer. The study ia s randomized controlled double-blind multicenter study. The investigators will use information from Danish National Patient registry, and data from the Danish Pathology Data Bank. Enrollment will take place at the Departments of Gynecology in Denmark. Eligible women aged ≥ 50 years will be randomized 1:1 to receive local vaginal estrogen or placebo prior to the colposcopic examination. The investigators believe the results will provide the prerequisite for obtaining correct diagnosis, and thereby provide basis for choosing the right individualized examination- and treatment plan. The results will also contribute with important knowledge, that may help reduce the incidence and mortality rate of cervical cancer.

Young adults aged 18-39 years with cancer often experience physical, psychological, and social challenges that affect their participation in everyday life and their health-related quality of life. Existing cancer rehabilitation services are rarely tailored to the specific needs of this age group. The Young Adults Taking Action (YATAC) programme was developed together with young adults with cancer, healthcare professionals, and researchers to provide age-specific rehabilitation that supports young adults in managing cancer-related challenges and returning to everyday life. The aim of this pilot randomized controlled trial is to evaluate the feasibility of conducting a larger trial of the YATAC programme in a municipal rehabilitation setting. The study will examine recruitment, retention, acceptability of randomization, data completeness, assessment burden, and adverse events. In addition, the study will provide preliminary estimates of the programme's effects on health-related quality of life and self-efficacy. Fifty young adults aged 18-39 years who are undergoing or have completed curative-intent treatment will be recruited through municipal cancer rehabilitation services in Aarhus Municipality, Denmark. Participants will be randomly assigned to receive either the 16-week YATAC programme or usual cancer rehabilitation services. The YATAC programme includes an individual needs assessment and goal setting, followed by group-based and individual sessions addressing physical activity, fatigue, sleep and cognitive challenges, mental health, sexuality and relationships, family and friends, nutrition, and education or work. Outcomes will be assessed at baseline and at 4, 6, and 12 months after enrolment.

The study examines the concentrations of nitrous oxide that are achieved in blood, exhaled air, and urine after three different exposures to nitrous oxide: inhalation of three or four cartridges of nitrous oxide released in a car cabin in a switched-off car, consumption of 100 g of whipped cream in which nitrous oxide is used as a propellant, and exposure through work as a midwife in a delivery room. The concentrations in blood and exhaled air are measured for up to 1 hour after exposure, and in urine for up to 2 hours after exposure. The concentrations in blood and urine are measued with gas chromatography and mass spectrometry, while the concentration in exhaled air is measured by a sensor using an NDIR sensor (Olythe, France).

Dysphagia is a frequent complication following stroke, with an estimated prevalence of 42%. One training modality which have been implemented in both hospitals and municipalities for alleviating dysphagia are oral neuromuscular training devices. These devices are hand-held acrylic devices which are inserted between the lips and teeth by the patient or an assistant and pulled forward against lip pressure. According to the developers of one of these devices coined IQoro, the training strengthens the orofacial and pharyngeal muscles. One of recent studies by the developer of IQoro, have demonstrated a positive effect of IQoro in improving swallowing function and reducing clinical signs of aspiration among older people in intermediate care. However, aspiration risk was based on unblinded subjective water swallowing tests, and findings may therefore be biased. Additionally, it should be considered that the study was a cluster-randomized study, in which the intervention was performed in some care units, and the usual care was performed in other care units. Since usual care is not described in detail, results in favor of IQoro may also be due to differences in the usual care practice between care units. Focusing on individuals with stroke, only observational studies have been carried out. These studies have shown functional improvements in all four quadrants of the mouth, improved lip strength, and improved swallowing capacity. However, observational studies suffer from the inherent limitation that it is not possible to establish whether training with IQoro is actually the cause of these improvements. The present research group recently published a small Randomized Controlled Trial (RCT), investigating the effectiveness of IQoro on swallowing function and decannulation in a very selective population of patients with cuffed tracheostomies due to severe acquired brain injury . Here, 22 subjects were randomized to either usual care, or usual care plus IQoro training as an add-on. In the study, there was no effect of IQoro in either time until decannulation, or swallowing function (as the implicit mechanism of action), compared with usual care. Patients with cuffed tracheostomy tubes are a very selective patient group, and results may not be generalized to a broader group of patients with post-stroke dysphagia. Based on this, more high-quality clinical trials with IQoro, on a broader population of patients with dysphagia admitted for neurorehabilitation is warranted, in order to clarify whether training with IQoro have an effect on swallowing. Aim and hypothesis The aim of this study is to investigate the effectiveness of oral neuromuscular training with IQoro on swallowing function in patients with dysphagia due to stroke. The hypothesis is that patients will have improved swallowing function because of training with IQoro as an add-on to usual care, compared with patients who only receive usual care. Study design An assessor-blinded randomized controlled trial. Study participants will be randomly assigned to either the IQoro (intervention group) or usual care (control group). The trial will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and approved by the Danish National Medical Research Ethics Committee

Acute heart failure is a condition where the heart suddenly cannot pump blood well enough for the body's needs. Many people admitted to the hospital with acute heart failure have too much fluid in the body. This can cause shortness of breath, swelling, and the need for treatment with water-removing medicine. Furosemide is a commonly used water-removing medicine that is given into a vein to treat fluid overload. It can be given in different ways. One way is as a continuous infusion, where the medicine is given slowly over time through a pump. Another way is as repeated injections given several times a day. It is not known whether one of these ways is better than the other for removing excess fluid in people with acute heart failure. The purpose of this study is to compare two ways of giving furosemide into a vein: Continuous infusion started with an initial extra dose, and bolus injections given three times a day. About 436 adults admitted to hospitals in Denmark with acute heart failure and fluid overload will take part. Participants will be randomly assigned to one of the two treatment groups. This means that chance will decide which treatment method each participant receives. The main thing the researchers will measure is how much body weight participants lose about 3 days after randomization. Weight loss is used as a measure of how much excess fluid has been removed.

OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively). The study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.

This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery. Adult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety. The purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.

Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if RSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with rotator cuff arthropathy eligible for unilateral RSA. The investigators hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (14-point, on a scale from 0-100) improvement compared to the exercise intervention.

This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.