There are about 11304 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This trial is a randomized controlled trial aimed at assessing the effectiveness of a nine-month-long professional development program to improve early childhood educators' and carers' self-efficacy for science approaches, engagement with science, and attitudes toward science in early childhood education and care (ECEC).
Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction (MI), stroke or hospitalization for HF. To compare revascularization by PCI versus by CABG, we will perform a multicentre, open-label, parallel, randomized, controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics, where guidelines acknowledge that both PCI and CABG are relevant treatment options.
The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.
Ischaemic Heart Disease (IHD) is the worlds leading cause of death. IHD is often caused by a narrowing of the coronary arteries, which prevents blood from flowing to the heart muscle, causing pain and damage to the heart. If an individual has a myocardial infarction (MI), parts of the heart that are damaged cannot be repaired. Therefore, it is important to identify and treat the narrowing of the arteries before an MI occurs. At present there are 2 main methods of identifying narrowing of the arteries. The first is an invasive procedure, the other using a CT scan. Whilst both methods are effective, they entail risk. The invasive procedure can damage the coronary arteries, whilst the CT scan exposes patients to radiation and contrast, which can increase the risk of cancer and allergic reactions. Magnetic Resonance (MR) scanning is an alternative to these methods, but it has been limited in use in the past due, in part, to the high technical knowledge required to obtain images. In addition, there is a degree of subjectivity in the selection of the mid-diastolic rest period, potentially affecting consistency of results. This means it is difficult to use in a day-to-day hospital environment. However, recent technological developments using artificial intelligence mean that images can be acquired in a more automated and consistent fashion. This new scan has yet to be tested in a clinical trial. Therefore, the objective of the clinical study is to test this new scan to determine its efficacy. 230 patients at 5 sites at risk of coronary artery disease, who have been referred for invasive coronary angiography, will undergo both their angiography and the new MR scan. The MR scan will then be compared to CCTA for diagnostic accuracy and image quality. The investigators hypothesise that the new MR scan will have the same diagnostic accuracy as invasive coronary angiography, with no differences in interpretation of the images across the 5 different hospitals. If proven effective, this would demonstrate that MR scanning of the coronary arteries could prove a safe, clinically useful alternative to both CT scanning and invasive assessment of coronary artery narrowing. In addition, if there is no difference across different locations, it would demonstrate that these scans can be performed consistently, facilitating implementation on a healthcare-system wide basis.
MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2024. The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice
Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME. Trial Title CME versus standard right hemicolectomy for right sided cancers Internal ref. no. Clinical Phase Trial Design Observational, prospective, international, multi-center study Trial sites 10 sites over 5 different countries Planned Sample Size At least 330 subjects will be enrolled in this study per cohort, including 10% of lost to follow-up patients). All patients during the enrolment period shall be screened and recorded at sites in order to identify any selection bias Treatment duration 3 years Follow up duration 5 years Planned Trial Period 10 years Objectives Outcome Measures Primary To compare the lymph node yield between complete mesocolic excision versus standard right hemicolectomy for patients with right sided cancer Number of harvested lymph nodes Secondary Incidence of local recurrence after surgery at 2 and 5 years Disease free survival (2 and 5 years) 5-year overall survival 30-day and 90-day mortality, 60-day postoperative major complications (As measured by the Comprehensive Complication Index (CCI®).) Pathological quality assessment. Completeness of mesocolon excision (CME) will be assessed by the pathologist Operative length of time (total OR utilisation time and operative time skin to skin, minutes) Assessment of intraoperative adverse events within advanced minimally-invasive surgery in order to report "near misses" and associated impact upon clinical outcomes Conversion to open surgery For Minimally invasive CME or standard right hemicolectomy - to compare the types of anastomosis (intra-corporeal versus Extra-coporeal ) on anastomosis leak rate 4. 5. 6. 7. Recurrence picked up on intensive follow up schedules with yearly CT scan for 5 years Definitions: Distal resected margin ≥ 5cm Lymph node yield Mesocolic plane of surgery Central vascular ligation (within 1cm of ileocolic vessels origins) R0 resection (all margins clear) Investigational Medicinal Product(s) n/a Formulation, Dose, Route of Administration n/a
This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study. Study outline: After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel
The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.
The aim of this study is to investigate whether virtual reality assisted stationary cycling exercise results in more physical activity than conventional unsupervised stationary cycling exercise. Physical activity levels are reported for both exercise duration and volume and non-exercise activity.
The aim of the study is to evaluate the effect of botox injections at the spermatic cord in patients with chronical scrotal pain. A lot of patients experiences depressive symptoms and a lot feel isolated. The etiology if not fully understood and the condition poses a challenge for physicians. The is no efficient minimal invasive treatment for these patients, and in severe cases patients are having there testicle removed. By inject botox around the spermatic cord the investigators hope to relieve some of the pain in these patients and offer patients a new minimal invasive treatment. The investigators aim to include 50 patients in this study, There will be randomised 1:1 to either the intervention arm (Botox) or control arm (sterile saline). Both patients and physicians will be blinded to the treatment. Patients will undergo a thorough physical examination and will be asked to fill out questionaries to asses their quality of life. After inclusion, patients will be followed closely for three months with physical examination and questionnaires. After three months, patients in the control arm will have the opportunity to cross over to the intervention arm. Data will be reported continuously.