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.
DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques and there is little specific evidence on how to best treat these cases. It is hypothesized that balloon lithoplasty is superior to conventional balloons for lesion preparation of severely calcified coronary lesions before stent implantation in terms of procedural failure and 1-year target vessel failure.
Aim The aim of the study is to characterize the typical basic life support (BLS) course participant. The characterization include age, sex, education, ethnicity, income, health care data and cohabitation. All data will be compared with that of the general population. Hereby the study wish identify potential focus areas for recruitment of willing and able bystanders to increase survival. Furthermore, this study will provide a foundation for evaluation of current initiatives. Significance In Denmark, several population-based campaigns have been initiated to increase the amount of able and willing laypersons to assist at out-of-hospital cardiac arrest (OHCA). The main focus has been on increasing the quantity of laypersons attending BLS courses. Even measures of changing legislation mandating course participation have been passed and implemented. Estimates state that approximately 3-4.5% of the entire Danish population participates in BLS courses annually. Consequently, a substantial amount of resources has been spent on educating and certifying laypersons in BLS on a population level. In this study, the characteristics of these BLS course participants will be described. This will provide the basis for evaluation of already implemented interventions. Additionally, this study will be able to support course distributors, foundations and national councils in making strategies for further recruitment based on evidence. The present study will assist in pinpointing society groups with a theoretical bystander potential, but low level of BLS education. This can guide future efforts in trying to improve bystander initiated cardiopulmonary resuscitation (CPR) and survival from OHCA. Methods The study population includes all Danish citizens who attended a BLS training course certificate from 2016-2018 above the age of 15. This cut off is based on the earliest mandatory BLS training in primary school. Using Personal Identifications Numbers (PIN) of BLS course participant from January 1st, 2016 to December 31st, 2018, data will be extracted and delivered anonymously, including information on age, sex, income, education, ethnicity and cohabitation, from the Statistics Denmark. The relative risk of BLS course attendance stratified by education and income level, cohabitation status, age of youngest child, urbanization level, sex and ethnicity of the Danish BLS course participants compared to the general population will be presented. Prevalence of BLS courses participants by age and sex will be analyzed and graphically display and prevalence of BLS course participants by income and age will be calculated by regression models. A layperson focus group interview consisting of BLS course participants will be conducted to explore the attending courses participants views of the project and to revise accordingly. Anonymity is secured through a data processing agreement between the Danish First Aid Council and Statistics Denmark, facilitated by the Copenhagen Emergency Medical Services. An application will be formulated to the Danish Data protection agency regarding storage of data. Expected outcome A characterization of the typical BLS course participants in Denmark with median age, sex, cohabitation, income and education. The association between sociodemographic characteristics of BLS course participants and relevant prevalence's by the entire population will be presented.
Pancreatic ductal adenocarcinoma (PDAC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. A locally unresectable tumor (locally advanced pancreatic cancer (LAPC)) is present in 30% of the cases and is defined as a surgically unresectable tumor encasing the adjacent arteries [celiac axis, superior mesenteric artery (SMA)]. In these patients, chemotherapy has been the standard treatment for decades, optionally combined with radiotherapy. Patients with borderline resectable pancreatic cancer (BRPC) comprise a group of patients with PDAC who are at a high risk of having positive margins if upfront resection is pursued. In addition, multiple studies have reported these patients have increased probability of early recurrence of local and systemic disease resulting in poorer outcomes. Although some patients are treated with an aggressive surgery-first approach and adjuvant systemic therapies, a preoperative chemotherapy and/or chemoradiation approach is becoming more common for all patients with BRPC, and this strategy is adapted in Danish and international guidelines. Majority of patients present with metastatic pancreatic cancer (mPC). Therapy options are limited by chemotherapy in palliative setting. The superiority of the FOLFIRINOX regimen demonstrated in the phase III mPC setting led many centers to investigate FOLFIRINOX with or without chemoradiotherapy in patients with LAPC tumor. Gemcitabine combined with nab-paclitaxel is the approved first-line treatment for patients with advanced PC. This regimen showed a median progression-free survival (PFS) of 5.5 months and a median overall survival (OS) of 8.5 months and is the predominantly used regimen in metastatic PC. The role of radiation therapy in the management of nonresectable PC remains controversial. The results of small randomized trials comparing chemoradiotherapy with chemotherapy of patients with LAPC are divergent. Immunotherapy has emerged as a therapeutic approach that offers effective and durable treatment options for subsets of patients with various types of cancer. However, these successes have not manifested similar benefits for PDAC patients mostly due to a lack of pre-existing T-cell immunity and/or a highly immunosuppressive tumor microenvironment (TME). Considering the emerging role of the TME, the combination of checkpoint blocking antibodies with agents that target the inhibitory effects of the TME could lead to better responses in tumor historically resistant to checkpoint blocking antibody approaches. For example, in heavily pretreated patients with advanced/metastatic PDAC, preliminary data from the phase 2 study CHECKPAC (NCT02866383) showed that checkpoint inhibition in combination with stereotactic body radiotherapy (SBRT) provided durable clinical benefit in a small proportion of patients, including prolonged, sustained partial responses. Furthermore, the addition of standard-of-care chemotherapy could further potentiate the anti-tumor effects of immunotherapy approaches by reducing the tumor burden, exposing antigens, and directly affecting the immunosuppressive TME compartment. To explore the safety and synergy of the proposed combinatorial approach, participants with borderline resectable, locally advanced or mPC will receive nivolumab and ipilimumab administered in combination with gemcitabine and nab-paclitaxel followed by immune-chemoradiation.
The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).
A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies. The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection. 50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).