[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Aarhus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":673},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,155,0,25,[9,47,75,100,122,152,176,203,230,252,275,295,321,351,379,409,437,472,497,520,540,570,598,628,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100652377","oral-galactose-as-a-substrate-for-post-exercise-skeletal-muscle-glycogen-repletion-in-individuals-with-type-1-diabetes-100652377",false,"NCT07774780","Oral Galactose as a Substrate for Post-Exercise Skeletal Muscle Glycogen Repletion in Individuals With Type 1 Diabetes","Inclusion Criteria:\n\n* Healthy or T1D\n* BMI 18,5-30 kg\u002Fm2\n* Singed informed consent\n\nExclusion Criteria:\n\n* Clinically significant heart, lung, kidney, liver, endocrine, or malignant disease based on information collected during the initial screening visit as well as blood tests\n* Lack of awareness of hypoglycemia episodes\n* Blood donation within the last 3 months\n* Smoking\n* Alcohol or substance abuse\n* Participation in other studies involving ionizing radiation within the last 6 months\n* Claustrophobia\n* Inability to train one leg for one hour",true,"ALL","20 Years","70 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"NA","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).\n\nAlthough 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.\n\nPrevious 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.\n\nThis 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.",[28],"Type 1 Diabetes",[30,31,32,33],"Galactose metabolism","Skeletal muscle uptake of Galactose","Hepatic galactose uptake","Cerebral galactose uptake","NOT_YET_RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-19","ACTUAL",{"date":40,"type":22},"2027-02-01",{"date":42,"type":22},"2029-05-31",{"name":44,"class":45},"University of Aarhus","OTHER",2,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100651934","prodiap---patient-reported-outcomes-in-general-practice-among-people-with-type-2-diabetes-100651934","NCT07767331","PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes","PRODIAP - Patient-Reported Outcomes in General Practice Among People With Type 2 Diabetes","PRODIAP","Inclusion Criteria:\n\n* type 2 diabetes\n* able to understand and answer a Danish questionnaire\n\nExclusion Criteria:\n\n* none","18 Years",{"count":57,"type":22},2000,[25],"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.\n\nThis project applies a mixed-methods design with two sub-studies:\n\n1. 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.\n2. A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives.\n\nThe 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.",[61],"Type 2 Diabetes",[63,64,65],"Patient Reported Outcome (PRO)","General Practice (GP)","Randomised controlled trial","RECRUITING","2026-08-14",{"date":35,"type":38},{"date":70,"type":38},"2026-03-01",{"date":72,"type":22},"2028-02",{"name":44,"class":45},1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":74},"100650805","a-brief-psychological-intervention-for-carer-fear-of-cancer-progression-100650805","NCT07752992","A Brief Psychological Intervention for Carer Fear of Cancer Progression","Conquer Fear Carer Brief: A Brief Psychological Intervention for Fear of Cancer Progression in Caregivers of Patients With Metastatic Prostate Cancer: A Feasibility Study","Inclusion Criteria:\n\n* Self-identified caregiver of a patient with metastatic, non-curable prostate cancer\n* Aged ≥18 years\n* Score in the clinical range (≥22) on the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)\n* Score in the clinical range (\\>15) on the Brief Penn State Worry Questionnaire (PSWQ)\n* Sufficient proficiency in Danish\n* Able to provide informed consent\n* Stable or no use of antidepressant or anxiolytic medication (i.e., stable dosage for ≥6 weeks)\n* Able to participate in online-delivered therapy via a computer with a video camera\n\nExclusion Criteria:\n\n* Severe psychiatric conditions (e.g., major depression) that would make participation in the intervention inappropriate\n* Currently enrolled in psychotherapy or counseling targeting the same problem\n* Substance abuse or dependence judged to require treatment\n* Suicide risk requiring immediate psychiatric intervention or hospitalization",{"count":83,"type":22},14,[25],"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.",[87],"Fear of Cancer Progression",[87,89,90,91,92],"Caregivers","Metacognitive therapy","Feasibility","Online-delivered psychological therapy","2026-08-05",{"date":95,"type":38},"2026-08-07",{"date":97,"type":38},"2026-06-15",{"date":72,"type":22},{"name":44,"class":45},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":74},"100549457","blood-flow-restriction-exercise-in-patients-with-an-achilles-tendon-rupture-100549457","NCT06434272","Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture","The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically","BEAN","Inclusion Criteria:\n\n* aged 18 years or older\n* have started initial treatment within 72 hours of Achilles tendon rupture\n* understand written and spoken Danish\n\nExclusion Criteria:\n\n* bilateral Achilles tendon rupture\n* previous Achilles tendon rupture in either leg\n* decreased lower extremity function, caused by conditions other than Achilles tendon rupture\n* treated with fluoroquinolones within the last six months\n* treated with corticosteroid injection(s) in the area near the Achilles tendon within the last six months.\n* diabetes\n* previous diagnosed thrombosis\n* Known atherosclerosis in the peripheral arteries of the lower limb\n* other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)",{"count":109,"type":22},218,[25],"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:\n\nIs 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.\n\n* Either in the initial 1-12 weeks after Achilles tendon rupture, or\n* In the following 13-24 weeks after Achilles tendon rupture\n\nResearchers 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).",[113],"Achilles Tendon Rupture","2026-08-03",{"date":116,"type":38},"2026-08-04",{"date":118,"type":38},"2025-01-28",{"date":120,"type":22},"2028-01-09",{"name":44,"class":45},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":142,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":46},"100625933","effectiveness-of-a-vaginal-gel-on-cin12-regression-and-hpv-clearance-100625933","NCT07429071","Effectiveness of a Vaginal Gel on CIN1\u002F2 Regression and HPV Clearance.","Effectiveness of Coriolus Versicolor-based Vaginal Gel on HPV Clearance and Regression of Cervical Intraepithelial Neoplasia: a Multicenter Randomized Controlled Trial","Inclusion criteria:\n\n* Aged 30-50 years\n* A positive hrHPV test with histopathological confirmed CIN1 or CIN2\n* Managed under a 'watchful waiting' strategy as part of standard management\n* Understand Danish, both written and orally\n\nExclusion criteria:\n\n* Pregnancy or breastfeeding\n* Unexplained vaginal bleeding\n* Immunosuppressive or immunomodulatory conditions or treatment\n* Diabetes mellitus\n* Prior hysterectomy\n* Any ongoing cancer diagnosis, prior CIN3 or a history of malignancy in the genital\u002Fanal region within 5 years (excl. non-melanoma skin cancer)","FEMALE","30 Years","50 Years",{"count":133,"type":22},70,[25],"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\u002FCIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome.\n\nThe primary outcomes therefore is:\n\n• hrHPV clearance from baseline to follow-up (6 months)\n\nIn this randomized controlled study, eligible participants will be randomized 1:1 into two groups:\n\n1. 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).\n2. Control group; Women (n=35) will follow the conventional \"wait and see\" approach.",[137,138,139,140,141],"Womens Health","Cervical Dysplasia","Cervical Intraepithelial Neoplasia (CIN)","Non-invasive Treatment","Human Papilloma Virus (HPV)",[137,138,139,143,144],"Human Papillomavirus (HPV)","Non-Invasive Treatments","2026-07-31",{"date":114,"type":38},{"date":148,"type":38},"2026-06-09",{"date":150,"type":22},"2026-12",{"name":44,"class":45},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":129,"minAge":131,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":74},"100461037","improving-diagnostics-in-cervical-dysplasia-100461037","NCT05283421","Improving Diagnostics in Cervical Dysplasia","Improving Diagnostic in Cervical Dysplasia: A Randomized Study With Local Estrogen Prior to Colposcopy","IDEAL","Inclusion Criteria:\n\n* Postmenopausal (defined as no bleeding ≥1 year) women referred for colposcopy aged ≥ 50 years.\n* Women referred for colposcopy due to a positive HPV test and\u002For an abnormal cervical cytology.\n* Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies.\n\nExclusion Criteria:\n\n* Use of estrogen within the last 3 months regardless of administration form.\n* previous cervical radiotherapy, cervical amputation and\u002For cone biopsy\n* pregnancy",{"count":161,"type":22},150,[25],"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.\n\nTo 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.\n\nConsequently, 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.\n\nFew 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.",[165],"Cervical Cancer",[167,168],"Colposcopy","Estrogen","2026-07-30",{"date":145,"type":38},{"date":172,"type":38},"2023-08-23",{"date":174,"type":22},"2026-08-16",{"name":44,"class":45},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":74},"100646156","evaluating-the-yatac-programme-100646156","NCT07692763","Evaluating the YATAC Programme","The Young Adult Taking Action Program: Protocol for a Pilot Randomized Controlled Trial of Cancer Rehabilitation for Young Adults","YATAC","Inclusion Criteria:\n\n* Between 18 and 39 years of age\n* Are currently undergoing or have completed curative-intent cancer treatment within the past five years\n* Can understand and communicate in Danish and provide informed consent independently\n* Have been referred to municipal cancer rehabilitation services in the Municipality of Aarhus\n\nExclusion Criteria:\n\n* Diagnosed with cancer before the age of 18\n* Previously or currently receive rehabilitation","39 Years",{"count":186,"type":22},50,[25],"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.\n\nThe 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.\n\nFifty 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.",[190,191],"Cancer","Young Adults",[65,193,194],"Quality of life","Rehabilitation","2026-07-09",{"date":197,"type":38},"2026-07-10",{"date":199,"type":38},"2026-07-03",{"date":201,"type":22},"2028-12-31",{"name":44,"class":45},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":74},"100646478","concentrations-of-nitrous-oxide-in-blood-exhaled-air-and-urine-after-various-types-of-exposure-100646478","NCT07690358","Concentrations of Nitrous Oxide in Blood, Exhaled Air and Urine After Various Types of Exposure.","Undersøgelse af Lattergaskoncentrationer i Blod, udåndingsluft og Urin Ved Forskellige Eksponeringer","For arm 1, 2, and 3:\n\nInclusion Criteria:\n\n* Age 18-65 years\n* Able to understand Danish\n* Willing to use effective contraception for 24 hours after the end of exposure (oral contraceptives, contraceptive implant, transdermal patch, vaginal ring, or injectable contraceptives)\n* Written informed consent\n\nExclusion Criteria:\n\n* Current or past abuse of drugs, nitrous oxide (N₂O), or alcohol\n* A psychiatric disorder requiring medical treatment, including severe depression\n* A diagnosis of epilepsy\n* Symptoms of peripheral neuropathy\n* Significant cardiac or pulmonary disease\n* Previous allergic or adverse reaction to N₂O\n* Diving within the past 2 days\n* Inability to refrain from diving for 2 days after the study\n* Occupational exposure to N₂O\n* Use of N₂O within the past 3 months\n* Treatment with methotrexate, benzodiazepines, opioids, or other centrally depressant drugs\n* Recent intraocular gas injection\n* Known impaired liver or kidney function\n* Pregnant or breastfeeding women (fertile women, defined as amenorrhea for less than 12 months, must have a negative hCG pregnancy test prior to receiving the study intervention)","65 Years",{"count":212,"type":22},40,[25],"The study examines the concentrations of nitrous oxide that are achieved in blood, exhaled air, and urine after three different exposures to nitrous oxide:\n\ninhalation 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.\n\nThe 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).",[216],"Intoxication by Drug",[218,219,220,221],"Nitrous oxide","Forensic chemistry","driving under the influence","laughing gas","2026-07-07",{"date":224,"type":38},"2026-07-08",{"date":226,"type":38},"2026-06-01",{"date":228,"type":22},"2026-12-31",{"name":44,"class":45},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":251,"locationsCount":74},"100627622","effect-of-an-oral-neuromuscular-training-device-on-dysphagia-100627622","NCT07451028","Effect of an Oral Neuromuscular Training Device on Dysphagia","Effect of an Oral Neuromuscular Training Device on Dysphagia: an Assessor-blinded Randomized Controlled Trial","Inclusion Criteria:\n\n* First-ever stroke\n* Dysphagia assessed with the FOTT-SAS\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Tracheostomy tube\n* Admitted for short-term evaluation\n* Lack of ability to cooperate with mouth closure\n* Contraindications for using IQoro",{"count":238,"type":22},100,[25],"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.\n\nThe 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.\n\nBased 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.\n\nAim 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.\n\nStudy 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",[242],"Dysphagia",[242,244,245],"Stroke","Oral neuromuscular training","2026-07-06",{"date":222,"type":38},{"date":226,"type":38},{"date":250,"type":22},"2027-12-31",{"name":44,"class":45},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":74},"100640947","phase-4-infusion-of-furosemide-to-improve-diuretic-efficiency-in-acute-heart-failure-100640947","NCT07577596","Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure","Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)","INFUSE-AHF","Inclusion Criteria:\n\n* Clinical diagnosis of acute heart failure with volume overload\n* At least 1 sign of volume overload\n* Anticipated intravenous furosemide treatment for at least 3 days\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Shock\n* Patient requiring treatment with inotropes or vasopressors\n* Current or planned use of renal replacement therapy or ultrafiltration\n* Patient with a renal transplant\n* Patients who are pregnant or breastfeeding\n* Severe hypokalaemia, defined as potassium less than 2.5 mmol\u002FL, or severe hyponatremia, defined as sodium less than 125 mmol\u002FL\n* Allergy to furosemide and its components",{"count":261,"type":22},436,[263],"PHASE4","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.\n\nFurosemide 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.\n\nThe 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.\n\nThe 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.",[266,267],"Acute Heart Failure","Volume Overload","2026-07-01",{"date":246,"type":38},{"date":271,"type":38},"2026-06-30",{"date":273,"type":22},"2027-10-01",{"name":44,"class":45},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":129,"minAge":131,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":74},"100520642","phase-4-the-optimised-use-of-romozosumab-study-100520642","NCT06059222","The Optimised Use of Romozosumab Study","OPTIMIST","Inclusion Criteria:\n\n* Postmenopausal women (postmenopausal for at least two years)\n* BMD T-score \\\u003C -2.5 at lumbar spine, total hip, or femoral neck\n* Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.\n\nExclusion Criteria:\n\n* Osteoporosis treatment including hormone replacement therapy within the last 5 years\n* Metabolic bone disease\n* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease\n* Ongoing treatment with glucocorticoids (systemic)\n* Estimated glomerular filtration rate (eGFR) \\\u003C 35 mL\u002Fmin\n* Contraindications for zoledronate according to the Supplementary protection certificates (SPC)\n* Contraindications for romosozumab according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC",{"count":283,"type":22},270,[263],"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).\n\nThe 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.",[287],"Osteoporosis",{"date":289,"type":38},"2026-07-02",{"date":291,"type":38},"2023-10-02",{"date":293,"type":22},"2032-08-31",{"name":44,"class":45},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":318,"leadSponsor":320,"locationsCount":74},"100645268","same-day-cochlear-implant-activation-sda-ci-100645268","NCT07681830","Same-Day Cochlear Implant Activation (SDA-CI)","Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients","SDA-CI","Inclusion Criteria:\n\n* Age 18 years or older\n* Indication for cochlear implantation according to national guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria: - Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician.\n\n\\-",{"count":238,"type":22},[25],"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.\n\nAdult 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.\n\nThe 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.",[307,308],"Hearing Loss","Cochlear Implantation",[310,311,312,313,314,315],"Cochlear Implant","Same-Day Activation","Early Activation","Electrode Impedance","Stable Cochlear Implant Map","Cochlear Implant Mapping",{"date":289,"type":38},{"date":226,"type":22},{"date":319,"type":22},"2029-12-01",{"name":44,"class":45},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":329,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100428830","prosthesis-versus-active-exercise-program-in-patients-with-rotator-cuff-arthropathy-100428830","NCT04864158","Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy","Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial","REACT","Inclusion Criteria:\n\n* Patients 60-85 years\n* Eligible for RSA\n* Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)\n\nExclusion Criteria:\n\n* Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)\n* Planned other upper extremity surgery within six months\n* Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA\n* Cancer diagnosis and receiving chemo-, immuno- or radiotherapy\n* Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)\n* Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.\n* Unable to communicate in the participating countries respective languages","60 Years","85 Years",{"count":332,"type":22},102,[25],"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.",[336],"Rotator Cuff Arthropathy",[338,339,340,341,342,343],"Physiotherapist-supervised Exercise","Physical Therapy","Physical Rehabilitation","Reverse Shoulder Arthroplasty","Randomized Controlled Trial","Cuff Tear Arthropathy",{"date":289,"type":38},{"date":346,"type":38},"2021-05-28",{"date":348,"type":22},"2037-01",{"name":44,"class":45},8,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":46},"100603259","fluorescence-guided-optimization-of-sarcoma-margins-100603259","NCT07134192","Fluorescence-Guided Optimization of Sarcoma Margins","FOCUS","Inclusion Criteria:\n\n* Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall\n* Age\\>18 years old\n* Tumor operable\n* Curative intent at time of surgery\n* Consent of patient\n\nExclusion Criteria:\n\n* History of allergic reaction to iodine-containing pharmaceuticals\n* End-stage renal disease or eGFR \\\u003C15\n* Patient decision\n* Lack of capacity\n* Inoperability",{"count":359,"type":22},90,[25],"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.",[363,364],"Soft Tissue Sarcoma of the Trunk and Extremities","Sarcoma",[364,366,367,368,369,370,371],"ICG","Indocyanine green","Fluorescence Guided Surgery","FGS","STS","Soft Tissue Sarcoma","2026-06-29",{"date":268,"type":38},{"date":375,"type":38},"2025-09-01",{"date":377,"type":22},"2028-03-01",{"name":44,"class":45},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":397,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":74},"100634333","wrist-injury-strengthening-exercise-wise-versus-usual-care-advice-for-improving-pain-and-function-100634333","NCT07538323","Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function","Progressive Resistance and Flexibility Exercises Versus Usual Care Advice for Improving Pain and Function After Distal Radius Fracture in Adults Aged 50 Years or Over in Denmark: the WISE-DK Randomised Trial","WISE-DK","Inclusion Criteria:\n\n* Distal radius fracture treated surgically or non-surgically\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Injury is more than two months old\n* There is evidence that the patient would be unable to participate in therapy or a self-guided exercise program provided by a participating center or adhere to study procedures (including cognitive impairment and fracture\u002Fsurgery complications such as Complex Regional Pain Syndrome)\n* No e-mail address to receive electronic questionnaires\n* Open fractures with a Gustilo \\& Anderson grading \\>1",{"count":388,"type":22},588,[25],"The goal of this clinical trial is to find out whether a therapist-guided exercise program helps people aged 50 and older recover better, in terms of pain and function, after a wrist fracture, compared to the usual care advice they would normally receive. The main question it aims to answer is:\n\n• Will participants who receive a therapist-supervised exercise program have better improvement in pain and function, as measured by the Patient Rated Wrist Evaluation questionnaire, six months after their injury?\n\nResearchers will compare these participants with those who receive usual care, which includes advice on self-management, to see if the supervised exercise program leads to greater recovery.\n\nParticipants will:\n\n* Either receive supervised exercise, with a therapy session of up to 60 minutes and two additional sessions of up to 30 minutes each in addition to usual-care, or they will receive solely usual-care, consisting of advice on self-management.\n* Complete questionnaires electronically at baseline, 3-months, and 6-months.",[392,393,394,395,396],"Distal Radius Fracture","Colles Fracture","Wrist Fracture","Wrist Fractures","Fracture Arm",[398,399,400,401],"Exercise","Therapy","Resistance training","Strengthening exercise","2026-06-26",{"date":271,"type":38},{"date":405,"type":38},"2026-05-12",{"date":407,"type":22},"2029-12",{"name":44,"class":45},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":16,"sex":129,"minAge":55,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":419,"briefSummary":420,"conditions":421,"keywords":425,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100408852","when-to-induce-for-overweight-window-100408852","NCT04603859","When to INDuce for OverWeight? (WINDOW)","When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)","WINDOW","Inclusion Criteria:\n\n• Pregnant women with pre- or early pregnancy BMI ≥ 30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Legal or ethical considerations: maternal age \\\u003C18 years, language difficulties requiring an interpreter or translator\n* Multiple pregnancy\n* Previous caesarean section\n* Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement\n* Planned elective caesarean section at time of randomisation\n* Fetal contraindications to IOL at time of randomisation: e.g. non-cephalic presentation, or other fetal conditions contraindicating vaginal delivery\n* Fetal contraindications to expectant management at time of randomisation\n* Maternal contraindications to IOL at time of randomisation: e.g. placenta previa\u002Faccreta, vasa previa\n* Maternal contraindications to expectant management at time of randomisation: e.g. maternal medical conditions, ultrasonically diagnosed oligohydramnios (DVP\\\u003C 2 cm), signs of labour including pre-labour rupture of membranes (PROM)",{"count":418,"type":22},1900,[25],"The rate of overweight and obese women becoming pregnant is increasing. Obesity in pregnancy along with delivery by cesarean section in obese women is associated with several complications as compared to normal weight women. The longer the woman is pregnant, the longer she is at risk. In an otherwise low-risk pregnant woman at term, it is an ongoing clinical dilemma, whether the benefits of elective induction of labor and termination of the pregnancy will outweigh the potential harms from concomitant induction and delivery process. The proposed study is a randomized controlled study of elective induction versus expectant management in obese women. The study will be carried out as a national multicenter study with inclusion of 1900 participants from Danish delivery wards. The null hypothesis is that the caesarean section rate is similar with elective induction of labor at 39 weeks of gestation, compared with expectant management among pregnant women with pre- or early pregnancy BMI≥30.",[422,423,424],"Pregnancy","Obesity","Parturition",[426,427,428],"Induction of labor","Expectant management","Cesarean section","2026-06-22",{"date":402,"type":38},{"date":432,"type":38},"2020-10-19",{"date":434,"type":22},"2026-07",{"name":44,"class":45},12,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":444,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":454,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":471},"100642134","phase-4-ironcare-iron-treatment-in-older-patients-with-hip-fractures-100642134","NCT07659184","IRONCARE: Iron Treatment in Older Patients With Hip Fractures","IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial","Inclusion Criteria:\n\n* Hip fracture (ICD-10 codes: DS720, DS721 and DS722)\n* Low energy trauma\n* Age ≥ 75 years\n* Hemoglobin ≤7.0 mmol\u002FL (11 g\u002FdL) during hospital admission\n\nExclusion Criteria:\n\n* Pathological fracture\n* Periprosthetic fracture\n* Inability to understand or speak Danish\n* Dysphagia and thus inability to swallow study medication\n* Signs of iron overload, hemochromatosis, or hemosiderosis\n* Liver disease (cirrhosis or hepatitis) and transaminase levels \\>3 times upper limit of normal\n* Known allergy to iron formulations\n* Severe asthma\n* Severe hypophosphatemia: \\\u003C0.35 mmol\u002FL\n* Patients already receiving iron supplementation that cannot be paused for the study period\n* Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score \\> 4","75 Years",{"count":446,"type":22},528,[263],"The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.\n\nThe trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).",[450,451,452,453],"Hip Fracture","Anemia","Iron","Placebo - Control",[455,451,456,457,458,459,460,461,462],"Hip fracture","iron","Intravenous iron","mobility","fatigue","hemoglobin","RCT","Placebo","2026-06-19",{"date":465,"type":38},"2026-06-24",{"date":467,"type":22},"2026-10-01",{"date":469,"type":22},"2028-09-30",{"name":44,"class":45},5,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":74},"100611967","transthoracic-drainage-of-lung-abscesses-a-national-randomized-trial-100611967","NCT07247461","Transthoracic Drainage of Lung Abscesses. A National Randomized Trial.","TOLA: Transthoracic Drainage of Lung Abscesses. A National Randomized Trial","TOLA","Inclusion Criteria:\n\n* Age \\>18 years.\n* Signed informed consent.\n* CT scan compatible with LA (one or more cavitating lesions with liquid content).\n* Clinical findings suggestive of ongoing infection.\n* Lung abscess size ≥ 4 cm in diameter.\n* Imaging indicates that the abscess contains fluid.\n* The abscess involves the outer one-third of the lung.\n\nExclusion Criteria:\n\n* Pregnancy. Prior to inclusion of fertile women, a negative pregnancy test must be available.\n* Brest feeding.\n* Predicted survival of less than 3 months.\n* Known tuberculosis or non-tuberculous mycobacteriosis.\n* Known chronic pulmonary aspergillosis.\n* Patients with a primary suspicion of lung cancer\n* Recent (\\\u003C3 months) contact with health facilities outside Scandinavia.\n* Patients in whom anticoagulant treatment cannot be discontinued, or in whom the treatment pause does not allow drainage within 72 hours.\n* Coagulopathy or other increased bleeding risk that cannot be corrected to allow drainage within 72 hours.\n* Hemodynamic and\u002For respiratory unstable patient.",{"count":481,"type":22},84,[25],"This study aims to investigate if early drainage of lung abscesses, in addition to standard antibiotic treatment, leads to shorter length of hospital stay.\n\nStudy Design\n\nThis is a randomized, controlled clinical trial. That means participants will be randomly assigned to one of two groups:\n\n1. Drainage group: Receives a chest tube (drain) inserted through the chest wall into the abscess in combination with standard intravenous antibiotics.\n2. Control group: Receives standard intravenous antibiotics only\n\nEach participant has a 50\u002F50 chance of being placed in either group.\n\nDuring Hospital Stay All participants will begin treatment with intravenous antibiotics (piperacillin\u002Ftazobactam). If assigned to the drainage group, a trained medical team will insert a small tube into the abscess to drain the pus. The tube is flushed three times a day with sterile saline.\n\nParticipants will also:\n\n* Fill out two short health questionnaires at the start and during follow-up.\n* Have relevant medical history collected from their hospital records.\n* Undergo routine scans (CT), blood tests, and lung assessments as part of standard care.\n* A cheek swab will be taken from all participants to study mouth bacteria..\n\nFor those receiving drainage the pus from the lung abscess will be collected for microbiological analysis.\n\nMicrobiology samples will be stored in a research biobank and destroyed after analysis.\n\nFollow-up after discharge\n\n* 1 week: A phone call to check symptoms and infection levels via a blood test.\n* 4 and 12 weeks later: In-person checkups at the lung clinic, including:\n\n  * 6-minute walk test\n  * Lung function test\n  * Repeat health questionnaires\n  * CT scan\n  * Blood tests (up to 20 ml in total over the study)\n* 1 years: Medical records are reviewed to asses morbidity and mortality.\n\nParticipants The study will include 84 adult patients who are hospitalized with a lung abscess larger than 4 cm, located near the outer part of the lung. Inclusion will take place at five university hospitals in Denmark\n\nWhy This Study Matters There are no official guidelines for treating lung abscesses, and research is limited. This study could offer vital new insights that help update treatment recommendations in Denmark and internationally.\n\nBecause all five Danish regions are involved, the results could quickly be implemented into daily practice, improving care for future patients with this serious condition.",[485],"Lung Abscess",[485,487,488,489],"Transthoracic drainage","Length of hospital stay","Randomized trial",{"date":491,"type":38},"2026-06-10",{"date":493,"type":38},"2026-02-16",{"date":495,"type":22},"2029-08-30",{"name":44,"class":45},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":74},"100643012","individualized-exercise-consultation-in-type-1-diabetes-100643012","NCT07596160","Individualized Exercise Consultation in Type 1 Diabetes","ACTIVE-T1D","Inclusion Criteria:\n\n* Diagnosis of type 1 diabetes\n* Age ≥18 years\n* Willingness to participate\n\nExclusion Criteria:\n\n* None",{"count":505,"type":22},60,[25],"People with type 1 diabetes often experience challenges managing blood glucose levels during and around physical activity, which may reduce participation in exercise. The ACTIVE-T1D project aims to evaluate whether individualized video-based exercise consultations can improve exercise-related confidence, physical activity levels, and glycemic management in adults with type 1 diabetes. Participants will receive individualized consultations focused on exercise, glucose management, insulin adjustment, and nutrition strategies related to physical activity. Consultations are tailored to the participant's exercise habits, goals, and challenges. The study will assess self-reported exercise management, physical activity, and glucose metrics obtained from continuous glucose monitoring systems. A subgroup of participants will also complete objective physical activity measurements using accelerometers. The study is conducted as a prospective quality improvement project at Steno Diabetes Center Aarhus.",[28],[510,511,512,513],"exercise","type 1 diabetes","intervention","consultations","2026-06-05",{"date":148,"type":38},{"date":226,"type":22},{"date":518,"type":22},"2028-06-01",{"name":44,"class":45},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":4},"100643717","internet-delivered-psychological-treatment-of-functional-gastrointestinal-disorders-100643717","NCT07636122","Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders","Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders - A Danish Feasibility Study","Inclusion Criteria:\n\n1. Age ≥ 18.\n2. A primary diagnosis of functional disorders, gastrointestinal, specifically irritable bowel syndrome operationalized by ROME IV (DR58)\n3. Normal recommended routine medical investigations: growth, blood samples including TSH, total IgA, IgA-tissue transglutaminase, complete blood count, erythrocyte sedimentation rate and C-reactive protein analysis, liver enzymes and fecal calprotectin.\n4. Refractory gastrointestinal functional symptoms despite medical treatment (in accordance with guidelines)\n5. Stable dosage of FGID-related medication such as laxatives, Imodium or pain-modulating psychopharmacological medication during the past month.\n6. Living in Denmark.\n7. Access to a computer or tablet with an internet connection.\n\n   \\-\n\nExclusion Criteria:\n\n1. \\- Another disease that explains the symptoms.\n2. Chronic inflammatory bowel disease (e.g., Crohns, colitis ulcerosa).\n3. Lactose intolerance, celiac disease, and food allergies, in accordance with guidelines.\n4. Severe psychiatric problems (e.g., suicidal ideation, depression).\n5. Insufficient language or computer skills.\n6. Addiction to alcohol, drugs or medicine.\n7. Treatment with opioids or other addictive drugs such as benzodiazepines\n8. Lactose-\u002Fgluten-intolerance where the diet has not been adjusted accordingly.\n9. Severe cognitive or intellectual dysfunction or diagnosed autism spectrum disorder, which prevent the participant from interaction with the program\n10. Ongoing psychological treatment.",{"count":528,"type":22},30,[25],"Brief Summary\n\nFunctional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), are common conditions characterized by recurrent gastrointestinal symptoms that cannot be fully explained by structural disease. FGID are associated with reduced quality of life, functional impairment, psychiatric comorbidity, and high healthcare utilization. Psychological interventions, particularly cognitive behavioral therapy (CBT), have demonstrated beneficial effects in FGID, but access to specialized treatment remains limited.\n\nThis study aims to evaluate the feasibility, acceptability, and potential clinical effects of a Danish exposure-based internet-delivered cognitive behavioral therapy (iCBT) program for adults with FGID. The intervention has been translated and culturally adapted from a Swedish program with previously documented efficacy.\n\nIn this single-arm feasibility study, 30 adults with FGID will complete a 10-week therapist-supported iCBT program consisting of psychoeducation, symptom monitoring, identification of avoidance behaviors, exposure exercises, and relapse prevention strategies. Participants will receive asynchronous weekly written support from trained CBT therapists.\n\nFeasibility outcomes include treatment adherence and completion, participant satisfaction, treatment credibility, working alliance, adverse effects, and acceptability of the internet platform. Clinical outcomes include gastrointestinal symptom severity and quality of life, alongside measures of illness perceptions, illness worry, emotional distress, behavioral responses, functional symptoms, and spontaneous cognition during rest. Assessments will be conducted at baseline, post-treatment, and 3-month follow-up.\n\nThe study is conducted in Denmark as part of The Danish FGID Treatment Study through collaboration between Aarhus University Hospital, Regional Hospital Silkeborg, Aarhus University, and Karolinska Institute, Sweden. The findings will inform the future implementation and evaluation of internet-delivered psychological treatment for Danish patients with FGID.",[532],"Functional Gastrointestinal Disorders (FGID)","2026-06-04",{"date":148,"type":38},{"date":536,"type":22},"2026-05-30",{"date":538,"type":22},"2027-12-20",{"name":44,"class":45},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":547,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":471},"100558448","phase-3-efficacy-of-solifenacin-mirabegron-and-combination-therapy-in-children-with-daytime-urinary-incontinence-bedry-100558448","NCT06551246","Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)","Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Overactive Bladder and Daytime Urinary Incontinence (BeDry)","Inclusion Criteria:\n\n1. The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.\n2. Age 5 to 14 years (inclusive) at the time of inclusion.\n3. Overactive bladder as per International Children's Continence Society criteria\n4. At least 2 daytime urinary incontinence episodes per week\n5. Inadequate effect of at least 4 weeks urotherapy (non-pharmacological treatment)\n6. No previous treatment with solifenacin, mirabegron or bladder\u002Fsphincter botulinum toxin injections\n7. No current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)\n8. Per investigator's judgment, the participant can swallow or can learn to swallow study medication\n\nExclusion Criteria:\n\n1. Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information\n2. Known or suspected hypersensitivity to study medication\n3. Any contraindication to the use of the study medication\n4. Known urogenital anatomical abnormalities affecting lower urinary tract function\n5. Known kidney or bladder stones\n6. Known diabetes insipidus\n7. Ongoing symptomatic urinary tract infection\n8. Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment\n9. Known QTc prolongation, QTc \\>460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)\n10. Other significant electrocardiogram abnormalities\n11. Known hypertension\n12. ≤3 daily voiding, evaluated by 48-hour frequency-volume chart\n13. Uroflowmetry suggestive of other pathology than overactive bladder (staccato-shaped, interrupted-shaped, or plateau-shaped curve)\n14. Post-void residual \\>50 ml after double voiding\n15. Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria\n16. Pregnancy or breastfeeding\n17. Female subjects of childbearing potential\n18. Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence\n19. Inability to swallow study medication\n20. Use of any medication during study period, except permitted medication","5 Years","14 Years",{"count":550,"type":22},236,[552],"PHASE3","The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.\n\nIn total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.",[555],"Urinary Incontinence in Children",[557,558,559,560,561,562],"Urinary incontinence","Daytime urinary incontinence","Overactive bladder","Children","Solifenacin","Mirabegron",{"date":564,"type":38},"2026-06-08",{"date":566,"type":38},"2024-06-27",{"date":568,"type":22},"2027-12-01",{"name":44,"class":45},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":580,"phases":4,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":597},"100635434","disease-activity-monitoring-in-patients-with-giant-cell-arteritis-study-100635434","NCT07552636","Disease Activity Monitoring in Patients With Giant Cell Arteritis Study","Disease Activity Monitoring in Patients With Giant Cell Arteritis","DiAcMo","Inclusion Criteria:\n\n1. Clinical GCA diagnosis established\u002Fconfirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis \\\u003C 3 years.\n2. Clinical remission at the time of inclusion, defined as\n\n   * Having adhered for ≥ 8 weeks prior to inclusion to either (a) the planned tapering of glucocorticoid therapy, or (b) the planned glucocorticoid-sparing DMARD treatment (with or without glucocorticoids).\n   * Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.\n   * Normal CRP level (\\\u003C 10 mg\u002FL) within 7 days before inclusion.\n3. Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.\n4. A continuous tapering of monotherapy or combination therapy is planned.\n5. Age \\> 50 years.\n6. Study participants must be able to speak and understand spoken and written Danish.\n\nExclusion Criteria:\n\n1. Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.\n2. Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.\n3. Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.",{"count":579,"type":22},175,"OBSERVATIONAL","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\u002For 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.",[583],"Giant Cell Arteritis (GCA)",[585,586,587,588],"vascular ultrasonography","disease activity monitoring","giant cell arteritis","patient-reported outcome measures","2026-05-27",{"date":591,"type":38},"2026-05-29",{"date":593,"type":38},"2026-05-06",{"date":595,"type":22},"2029-02",{"name":44,"class":45},7,{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":606,"targetDuration":607,"studyType":580,"phases":4,"briefSummary":608,"conditions":609,"keywords":617,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":627},"100633844","vascular-complications-after-kidney-transplantation-100633844","NCT07531966","Vascular Complications After Kidney Transplantation","Vascular Complications After Kidney Transplantation: A Prospective National Multicenter Study - The DAN-PTRAIII Study","DAN-PTRAIII","Inclusion Criteria:\n\n1\\. At least one of the following clinical criteria (1 or 2) must be fulfilled:\n\n1. Graft dysfunction, defined by at least one of the following:\n\n   * Acute reduction in estimated glomerular filtration rate (eGFR) \\>15% on two consecutive measurements at least 2 weeks apart, with other causes excluded (rejection, obstruction, infection).\n   * eGFR \\\u003C50% of the expected value 30 days after kidney transplantation of unknown cause.\n   * Decline in eGFR \\>30% after initiation of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.\n2. Persistent resistant hypertension for more than 6 weeks after kidney transplantation, defined as:\n\n   * 24-hour ambulatory systolic blood pressure \\>130 mmHg despite treatment with at least three classes of antihypertensive medication at maximally tolerated doses (including diuretics, if tolerated).\n\nTogether with at least one of the following radiological criteria:\n\n1. CT or MR angiography demonstrating a lumen reduction ≥50%.\n2. Doppler ultrasound showing:\n\n   1. Peak systolic velocity in the renal artery ≥200 cm\u002Fs and a renal renal ratio (velocity at stenosis \u002F velocity in distal artery) \\>4.\n   2. Acceleration time \\>70 ms in intrarenal arteries.\n\n2\\. In cases of strong clinical suspicion of a vascular complication where CT or MR angiography cannot reliably exclude graft artery or vein stenosis, patients may be referred for confirmatory invasive investigations.\n\nBefore PTA, catheter-based angiography and translesional pressure measurements are performed to confirm whether the patient meets the radiological eligibility criterion for PTA:\n\n1. Stenosis ≥70%.\n2. Stenosis 50-69% if at least one of the following criteria is met:\n\n   * Mean translesional pressure gradient ≥10 mmHg.\n   * Systolic pressure gradient ≥20 mmHg.\n   * Renal Pd\u002FPa ≤0.8.\n   * If pressure measurements cannot be obtained, treatment is based on the operator's clinical judgement.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. Concurrent biopsy demonstrating rejection requiring treatment.\n3. Pregnancy.\n4. Previous PTA of the same vessel.\n5. Patients unable to tolerate any form of antithrombotic therapy and therefore not eligible for stent placement.",{"count":505,"type":22},"10 Years","* To determine the incidence of arterial inflow problems and venous outflow problems as causes of impaired renal function and\u002For treatment-resistant hypertension after kidney transplantation, when all kidney-transplant recipients in Denmark are evaluated according to uniform, well-defined clinical criteria.\n* 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.\n* To assess whether novel imaging and functional diagnostic methods can predict treatment response.",[610,611,612,613,614,615,616],"Kidney Transplant Recipient","Kidney Transplant; Complications","Transplant Renal Artery Stenosis","Renovascular Disease","Renal Transplant Graft Failure","Renovascular Hypertension","Heart Failure",[611,612,618,619],"renovascular disease","Percutaneous transluminal angioplasty","2026-05-26",{"date":589,"type":38},{"date":623,"type":38},"2026-05-22",{"date":625,"type":22},"2031-06-01",{"name":44,"class":45},3,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":16,"sex":129,"minAge":18,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":646,"leadSponsor":648,"locationsCount":74},"100617344","investigating-the-effects-of-intermittent-hypoxia-hyperoxia-treatment-ihht-in-people-with-myalgic-encephalomyelitischronic-fatigue-syndrome-mecfs-to-improve-fatigue-pain-and-quality-of-life-by-targeting-mitochondrial-dysfunction-and-autonomic-nervous-system-impairment-100617344","NCT07317401","Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) to Improve Fatigue, Pain, and Quality of Life by Targeting Mitochondrial Dysfunction and Autonomic Nervous System Impairment","REenergizeME: Oxygen Therapy (OT) as a Novel Treatment for Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","REenergizeME","ME\u002FCFS Patients\n\nInclusion Criteria:\n\n* Female sex\n* Age 20-59 years\n* Established diagnosis of Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) according to the International Consensus Criteria (ICC)\n* Disease duration \\>6 months\n* Presence of post-exertional malaise (PEM)\n* Mild or moderate disease severity according to NICE guidelines\n* Body mass index (BMI) \\>18 and \\\u003C30 kg\u002Fm²\n* Ability and willingness to attend study visits and complete the intervention protocol\n* Provision of written informed consent\n* Willingness to comply with all study procedures and restrictions throughout the study period\n* Use of highly effective contraception during study participation for women of childbearing potential\n\nExclusion Criteria:\n\n* Severe ME\u002FCFS according to NICE guidelines\n* Participation in another clinical trial that may interfere with the present study\n* Pregnancy, planned pregnancy, or breastfeeding\n* Presence of clinically significant psychiatric disease not considered part of ME\u002FCFS and likely to interfere with study participation or interpretation of results\n* Presence of clinically significant neurological disease, peripheral nerve disorder, or other neurological dysfunction not considered part of ME\u002FCFS\n* Active internal disease or clinically significant cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease that may interfere with study participation or interpretation of outcomes\n* Obstructive lung disease\n* Claustrophobia\n* History of spontaneous pneumothorax\n* Presence of implanted medical devices, prostheses, or other conditions considered incompatible with IHHT\n* Chronic pain conditions not considered part of ME\u002FCFS and likely to interfere with assessments\n* Current structured graded exercise therapy (GET) or structured exercise programme\n* Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes\n* Inability to comply with study procedures or communicate meaningfully with study personnel\n* Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity\n\nHealthy Controls\n\nInclusion Criteria:\n\n* Female sex\n* Age 20-59 years\n* Body mass index (BMI) \\>18 and \\\u003C30 kg\u002Fm²\n* Ability and willingness to attend study visits\n* Provision of written informed consent\n* Good general health without clinically significant chronic medical, neurological, psychiatric, or pain conditions\n* Activity level and BMI broadly matched to ME\u002FCFS participants\n* Willingness to comply with all study procedures and restrictions throughout the study period\n* Use of highly effective contraception during study participation for women of childbearing potential\n\nExclusion Criteria:\n\n* Current or previous diagnosis of ME\u002FCFS\n* Participation in another clinical trial that may interfere with the present study\n* Pregnancy, planned pregnancy, or breastfeeding\n* Presence of clinically significant psychiatric, neurological, cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease\n* Chronic pain conditions, migraine disorder, or recurrent headache\u002Fback pain likely to interfere with study assessments\n* Obstructive lung disease\n* Claustrophobia\n* History of spontaneous pneumothorax\n* Presence of implanted medical devices, prostheses, or other conditions considered incompatible with study procedures\n* Current structured exercise programme or recent major change in exercise habits\n* Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes\n* Inability to comply with study procedures or communicate meaningfully with study personnel\n* Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity","59 Years",{"count":638,"type":22},104,[25],"This study is testing a new treatment for people with Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) and long-term symptoms after COVID-19. Both conditions cause extreme fatigue, muscle pain, \"brain fog,\" and trouble concentrating, which often get worse after physical or mental activity. Currently, no effective treatments are available.\n\nThe treatment being studied is called Intermittent Hypoxia-Hyperoxia Treatment (IHHT). It uses a machine called HypoxBreath to deliver short cycles of low oxygen (hypoxia) and high oxygen (hyperoxia) through a mask. Each session lasts 22-40 minutes and is carefully monitored to track oxygen levels, heart rate, and breathing. The therapy is customized for each patient to ensure comfort and effectiveness. IHHT is believed to help the body adapt to oxygen-related stress, improving energy production and reducing inflammation.\n\nIn this trial, 104 patients with ME\u002FCFS will be randomly assigned to receive either IHHT or a placebo treatment with normal oxygen levels over eight weeks. The placebo group will follow a similar procedure without oxygen changes. An additional 20 healthy individuals will be recruited as a comparison group, but they will not undergo the treatment.\n\nParticipants will have medical check-ups before and after treatment to evaluate changes in fatigue, mental sharpness, pain, autonomic nervous system function, and overall quality of life. Blood samples and small skin biopsies will also be taken to study the biological processes behind ME\u002FCFS and how the treatment works.\n\nThis research aims to find out if IHHT can improve the lives of people with ME\u002FCFS or long-term COVID symptoms. The results could also provide new insights into the causes of these challenging conditions and guide future treatments.",[642],"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) (ICD-10 G93.3)","2026-05-20",{"date":623,"type":38},{"date":226,"type":22},{"date":647,"type":22},"2029-01-01",{"name":44,"class":45},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":444,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":663,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":46},"100588237","how-bleeding-affects-delirium-in-older-patients-with-hip-fractures-the-improve-hip-study-100588237","NCT06938789","How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study","The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study","Inclusion Criteria:\n\n* Hip fracture\n\nExclusion Criteria:\n\n* Pathological hip fracture\n* Periprosthtic fracture\n* Unable to speak or understand Danish\n* Does not wish to recieve blood transfusion\n* If the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)",{"count":657,"type":22},198,[25],"The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is:\n\nDo patients aged 75 and older with hip fractures benefit from earlier treatment of anemia (low blood count) to reduce the risk of delirium?\n\nResearchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium.\n\nParticipants will:\n\nUndergo blood tests, have their vital signs monitored, and be screened for delirium three times a day for the first 48 hours after surgery.\n\nReceive blood transfusions promptly if their hemoglobin levels fall below a specified threshold.\n\nAttend a follow-up visit at 30 days to assess cognitive function and overall quality of life.\n\nAttend another follow-up at 90 days to evaluate hospital readmissions and survival.",[661,450,662],"Bleeding","Delirium - Postoperative",[455,664,665],"Delirium","Blood transfusion","2026-05-19",{"date":623,"type":38},{"date":669,"type":38},"2025-04-24",{"date":671,"type":22},"2027-06-01",{"name":44,"class":45},""]