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.
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.
Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.
Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapse when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aim of this study is to investigate whether CET as aftercare increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals. Design and methods: The study is implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol outpatient clinic will be randomized to one of the three following aftercare treatment groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100), and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups ((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)), and It will be explored whether CET as smartphone application is as effective as CET as group therapy. The groups will be compared in a number of parameters including alcohol intake, cravings and copings-strategies. Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there appears to be segregation in the empirical literature when it comes to treatment of addictive disorders. However, CET may allow the patient to practice and gain control over alcohol cue reactivity and associated high-risk situations in an inter-mediating therapeutic context before the patients inevitably are confronted by them. In this way, one might expect the transition from treatment to daily life less overwhelming and CET may help prevent relapse in the long term. Thus, CET may be particularly suitable as aftercare.
Hip fractures are associated with a large hidden blood loss. That is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. There is currently no viable method of identifying patients at risk of transfusion. The on admission haemoglobin level has been shown to be falsely reassuring . We are conducting a study of 200 consecutive hip fracture patients. Thrombelastography (TEG) is taken on admission. The results are blinded to clinicians. Results will be evaluated at the end of the study, comparing intra-operative and total blood losses with the TEG profile of the patient.
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
The purpose of this study is to describe the postoperative outcomes after laparoscopic transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of our experiences from the previous study to optimize the postoperative outcomes.
The present non-blinded randomized controlled trial (RCT) investigates the effect of a comprehensive discharge model in adult medical patients discharged directly home from an Acute Admission Unit (AAU). In addition, eligible patients should have, at least, one hospital admission 12 months prior to index hospitalization and be discharged for further follow-up by general practitioner, home care nursing or in an out-patient clinic. The model consists of 3 main steps during the short term stay in the AAU. First, patients are screened for pre-hospital conditions that might have contributed to the index hospitalization i.e. functional ability, ongoing treatment including drug treatment, need for additional assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses, walker. Second, at point of discharge there will be a thorough assessment of the discharge plan focusing on the patients' comprehension of the discharge plan as well as accept of the suggested treatment and follow-up. Third, within 2 days after discharge the patient will receive a discharge letter by email or postal mail written in plain language and repeating the information provided in the discharge summary to the general practitioner. Subsequently, the patient will receive a telephone follow-up from the research nurse addressing the content in the discharge letter and possible unresolved issues related to the index hospitalization. Patients in the control group receives the usual discharge practice in the AAU which does not include a discharge letter to the patient and telephone follow-up after discharge. The primary endpoint is number of readmissions within 72 hours and 30 days after discharge. Secondary endpoints are healthcare service utilization within 30 days after discharge this includes number of contacts to general practitioner, out-of-hours physicians, emergency departments and if possible visits by home care nurses. Additionally, Quality-of-Life measured 30 days after discharge by the questionnaire EQ5D and Patient Experience of the discharge process is measured 7 days after discharge by a Danish national patient experience survey - serves as secondary endpoints.
The objectives of this program are: to characterize and describe the Mucopolysaccharidosis IV type A (MPS IVA) population as a whole, including the heterogeneity, progression, and natural history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®, including, but not limited to, the occurrence of serious hypersensitivity reactions, anaphylaxis, and changes in antibody status; to help the medical community with the development of recommendations for monitoring MPS IVA patients and reports on patient outcomes to optimize patient care; to collect data on other treatment paradigms, and evaluate the prevalences of their use and their effectiveness; to characterize the effects and safety of Vimizim treatment 5 years from enrollment in the Registry for patients under 5 years of age; to monitor pregnancy exposure, including maternal, neonatal, and infant outcomes; and to monitor patients who have completed the MOR-005 and MOR-007 clinical trials. These patients will be encouraged to enroll in the applicable Registry Substudy and will be monitored using the MOR-005 and MOR-007 assessment schedules, respectively.
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties. The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks including screening, treatment period and a follow up visit. Subjects will receive once daily study treatment administration starting on Day 1. Study is planned to recruit approximately 120 subjects such that approximately 100 subjects complete the study.