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.
The purpose of this phase III parallel-group randomized controlled trial is to assess the efficacy of open dialogue about complementary alternative medicine integrated in conventional oncology care (ODC-COC). The investigators hypothesize that patients in the intervention group participating in an ODC-COC with a nurse specialist report better quality of life compared to patients in the control group receiving standard care alone.
Clinical Data Validation of a Novel Continuous Vital Sign Monitoring System in Cancer Patients Background The Cortrium C3 device is a novel, inexpensive, chest-worn unit designed for measuring vital sign parameters. The unit is capable of logging and wireless transmitting data describing pulse, respiratory rate, body surface temperature, ambient temperature and accelerometer data (1,2). The C3 device is developed as a diagnostic tool in the medical practice to meet the demand for a modern reliable and open medical grad vital sign monitoring system. The device is based on state-of-the-art technologies and is produced using high quality off-the-shelf components. Although, new technologies may be of high value to the health care system, studies show that the quality of technologies vary and more empiric data is needed to either support or reject the advantages of using intelligent health technologies at home (3-5). Besides measuring the actual quality of C3, it is therefore also important to evaluate how patients experience quality in relation to C3 in addition to an evaluation of perspectives from the health professionals. Objective The objective of the study is to validate measurements of pulse, frequency of respiration, and temperature obtained with the C3 device by comparison with routinely used hospital equipment. Further, the objective is to gain knowledge about how patients experience to be monitored with C3 and how hospital staff experience working with C3. Design and participants The study is carried out on cancer patients at the Department of Oncology, Naestved Hospital, Region Zealand, Denmark (DONZ). Collaborating partners are Cortrium, University College Zealand and Sundhedsinnovation Zealand. The study consists of a quantitative and a qualitative part. The quantitative study is a cross-sectional study of paired measures of vital sign parameters (pulse, respiratory rate and temperature) measured by the C3 device and standard hospital equipment used at DONZ. The qualitative study is planned as observational studies and semi-structured interviews with patients, who have been monitored with C3 and health professionals who have been involved in treatment or care of monitored patients. Recruitment of participants will take place amongst newly hospitalized patients at DONZ. It is planned to include approximately 40 patients in February and March 2016. Side effects, risks and inconveniences No major side effects are related to wearing and being monitored by the C3 device. The device has been tested on healthy volunteers and reports of inconveniences are mostly related to the adhesive ECG-electrodes that can irritate the skin. However, a wide array of electrodes are commercially available to fit the individual needs. Some might find wearing the device stigmatizing and/or inconvenient. In addition, the C3 device is marked CE class I. Hence, requirements for prevention of adverse effects are met. As an example, this includes two fuses between the battery and the electrodes, minimizing the risk of current for the battery entering the body even in the event of device failure. The device has not yet been approved for commercialization. Ethics and anonymization All data collected in the study is done according to the guidelines of Good Clinical Practice (GCP) for medical device studies (6). All data is anonymized, and is protected according to national law: "Lov om behandling af personoplysninger". The project has been reported to "Datatilsynet" [the Data Protection Agency]. Test subjects are secured access to further information about the study through their assigned nurse or email and telephone. Approvals The study has been approved by the Danish Ethical Comity: SJ-460, and The Danish Medicines Agency: journal number 2015120113.
Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.
The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test.
It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest. Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration. However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable. The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.
Background: Persons living with chronic conditions often have decreased ability to perform Activities of Daily Living (ADL) tasks, stressing a need to develop and evaluate intervention programs addressing decreased ADL ability. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the program "A Better everyday LifE" (ABLE), a home-based intervention program, was developed and feasibility tested. The current phase concerns a full-scale evaluation of the ABLE program including evaluation of effectiveness, processes and cost-effectiveness. Material and Methods: The design involves a randomized controlled trial, initiated with an internal pilot. The study will include eighty (n=80) home dwelling persons living with chronic conditions, experiencing problems performing ADL. Participants are randomized to either intervention (ABLE) or control (usual care). Co-primary outcomes are self-reported ADL ability measured using ADL-Questionnaire (ADL-Q) and observed ADL motor ability measured using Assessment of Motor and Process Skills (AMPS). Secondary outcomes are perceived satisfaction with ADL task performance measured using ADL-Q; observed ADL process ability measured using AMPS; and Goal Attainment measured using Goal-Attainment-Scaling (GAS). Data is collected at baseline, post intervention and six months after baseline. Process evaluation data are collected using registration forms and semi-structured qualitative interviews. The economic evaluation will be performed from a health care sector perspective with 6 months follow-up. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL ability.
Kidney cancer is a highly malignant disease with 950 new cases every year in Denmark. Diagnosis and treatment of kidney cancer patients presents many challenges because that early stages of the disease are often asymptomatic and the disease is thus often at advanced stage or even metastatic when discovered. Metastasis is a predictor of bad prognosis, because the presence of metastases excludes the possibility of curative treatment (surgery). Systemic (medical) treatment is used for metastatic disease. It is of increasing importance to monitor how patients are responding to the treatment and switch to a different product if the tumor is not responding. Improved methods for detection of metastatic lesions would be of great advantaged for the clinicians in order to select the optimal treatment strategy for the patients. In the present study we aim to identify tumor markers in the blood and more specific we want to investigate whether circulating tumor-DNA can be used as a biomarker for monitoring the development of the disease during and after treatment. We want a better understanding of the tumor's heterogeneity and development. Furthermore we want to evaluate the diagnostic value of dual time FDG- PET/CT for the detection of bone and lymph node metastases in patients with kidney cancer
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
The study aims to identify specific or potential reasons that prolong the length of hospital stay after video-assisted thoracoscopic surgery lobectomy. The hypothesis is that patients who are still in hospital after video-assisted thoracoscopic surgery lobectomy are associated with prolonged air leak, infection, pneumonia, atrial fibrillation or other complications or social factors.
To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state. VLDL-TG stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.