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 study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.
1. People living with type 2 diabetes are told that they have a significantly higher risk of developing a disease related to the heart or blood vessels. These diseases can play a major role for the overall health of the patient and can even cause death due to a blood clot in the heart, brain or other parts of the body. Understandibly, this information can cause a great deal of stress and anxiety for the patient. As of today a doctor can not determine which patient has a higher risk of disease in the Heart and blood vessels. Therefore, we see a great need for further exploration of the mechanisms that could help identify diabetic patients with a particularly high risk of developing these diseases. In this PhD project we aim at identifying diabetic patients with a specific pattern in the amount of proteins in the blood, tissue and genetic material who are at high risk of death or disease related to the heart and blood vessels. We explore this problem from two angles. In the first part of the PhD study, we identify and measure proteins, which are related to high risk of disease in the heart and blood vessels. These proteins come from the blood vessels (a specific part called the basement membrane) and are believed to be present in a higher concentration, when people have diabetes. At the same time, we measure the same proteins in a blood sample from the patients, and we also examine their genetic properties with a focus on specific genetic areas. All the tissue and blood samples have already been collected from patients, who have undergone a by-pass operation in the Heart at Odense University Hospital since 2008. All of the material is stored in a biobank (Odense Artery Biobank). We also collect data from Statictics Denmark about each individual. These data are used to categorize people into risk categories. We then hope to see a pattern in the measurements from the laboratory that match the risk profile of the patient. In the second part of the study we use a different approach. Data from a large study done on the population of Malmö, Sweden, can be used to examine the Development of blood vessels in diabetic patients. In this study healthy people from Malmö have undergone a number of examinations in the early 1990'ies and again 15 years later. One of the tests was an ultrasound of the large blood vessel on the neck, the carotid artery. With this ultrasound we are able to measure the thickness of the wall of the blood vessel and the diameter in which the blood can pass through. We think that there is a connection between diabetes and the diameter of the blood vessel and that, over time, diabetes can cause the blood vessel to become narrower. This idea links the two studies because the same proteins that can be found in the first study are important in determining the risk of having a narrow blood Vessel when the patient has diabetes. 2. This project can contribute with a deeper knowledge about the linking mechanisms between diabetes and disease in the heart and blood vessels: which proteins are present in higher concentration? How does this relate to a higher risk? How do diabetic blood vessels change over time? We will aim at answering these questions. With regards to clinical practice, we see several perspectives: - deeper knowledge and understanding of the mechanisms behind the diasease in the heart and blood vessels that follows diabetes - development of a new blood test. Over time, the proteins measured in this study could be developed to a new blood test that gives information about a patients risk of developing a diasease in the heart or blood vessels - better treatment for patients with diabetes because aptient with high risk can be treated more intensely In order to achieve the goals of this project there are several overall tasks: - select patients form the biobank, that are suitable for the project (the correct type of tissue and blood sample available) - do work in the laboratory. This includes cutting and preparing tissue, analyzing the tissue and blood samples, implementing new methods for analysis etc. - collect clinical data form Statistics Denmark. This process can be quite detailed and time consuming. - obtain data from 'The Diet and Cancer Study' in Sweden, Malmö - analyze data from study 1 - analyze data from study 2 - write articles - collect all parts of the projects in the final thesis
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com.
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.
During surgery high concentrations of supplementary oxygen are routinely administrated. However, there is increasing evidence of potential harm with liberal oxygen therapy. The hypothesis of the present study is that oxygen therapy adjusted to a normal arterial oxygen target is feasible and will attenuate the side effects of supplementary oxygen therapy. The study design is a before-and-after study in which 25 patients will follow the standard regime with high concentrations of oxygen therapy and 25 patients will be treated with oxygen to achieve a normal value of arterial oxygenation.
This cluster randomised trial aims to establish the effectiveness of an online intervention designed to improve the ability of parents to 'mentalise' - in other words to understand their own mental states and that of others including their partners and young children. Effects on maternal mental state, the quality of parent-child interaction and child language, social and emotional development will be assessed.
Over recent decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without severe male factor infertility. Despite the increasing use, there is no evidence to support that ICSI results in a higher live birth rate compared to conventional in vitro fertilisation (IVF) in cases without severe male factor infertility. The primary objective of this trial is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is live birth rate. A total of 824 participants with infertility without severe male factor will be included in the study and allocated randomly into two groups (IVF or ICSI). The main inclusion criteria for the women are age 18-42 years, normal to slightly decreased male partner sperm/ use of donor sperm and no prior fertility treatment. In addition to live birth rate, outcome measures include fertilisation rate, total fertilisation failure, embryo quality, clinical pregnancy, miscarriage rate, preterm delivery, birth weight and congenital anomalies of the child. The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Knowledge Centre on Data Protection Compliance. Study findings will be presented in international conferences and submitted for publication in peer-reviewed journals.