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.
To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track THA and TKA
The study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls. The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.
This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.
Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy, assessment of benefit and opioid reduction. Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which infiltrates local anesthetic between the internal oblique and transverse abdominis muscles and provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12) abdominal wall bilaterally using a four-point single-shot technique. Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain may have harmful physiologic, psychological consequences which potentially increase the morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8). Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy. Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to routine analgesic. To assess the difference in morphine usage in the first 48 hours after radical nephrectomy with or without applying of unilaterally dual TAP block.
Background: The prevalence of severe health anxiety is reported to be 1-2% in Western communities. This functional disorder is difficult for medical doctors to treat, the course of the disorder is often chronic, and that is costly for the social and health care systems as well as for the patients. A Cochrane metaanalysis from 2009 finds evidence for effectiveness of individual cognitive behavior therapy (CBT) for patients with hypochondriasis. But no randomised controlled trials (RCT) of the effectiveness of classical CBT delivered only in groups for patients with severe health anxiety (hypochondriasis/illness anxiety disorder) has yet been conducted. Aims: 1) to examine the effectiveness of group-CBT for patients with severe health anxiety compared to a wait-list group receiving usual care, 2) to perform a categorical and dimensional assessment of personality, 3) to examine predictors of outcome especially comorbid personality disorders, 4) to examine the relation between personality, illness perception and treatment outcome, 5) to compare the cost-effectiveness of these two treatments, 6) at a 2 years follow up to examine the course and long-term effectiveness of group-CBT for patients with severe health anxiety and some also followed by psychological treatment for comorbid personality disorders. Main hypothesis: Patients with severe HA who have received group CBT will at 6-month follow-up compared to a wait-list group receiving usual care show a significantly reduction in health anxiety. Methods: 84 patients referred from medical doctors during 2014-15 to the Clinic of Liaison Psychiatry in Koege, Region Zealand, Denmark, will be included and block randomised per 14 patients to either weekly group-CBT with 7 patients and 2 therapists for 3 hours a week in 12 weeks or wait-list with usual care for 9 months. Inclusion: Severe health anxiety (dominant mental disorder), score on WI-7>21,4, age 18-65 years, Danish speaking, informed consent. Exclusion: Another severe treatment demanding mental disorder, risk of suicide or psychosis, a serious somatic disease, pregnancy, dependency of drugs, alcohol or medication. Diagnostic assessment: The patients are included using research criteria for severe health anxiety (for ICD-11) and semi-structured interviews developed for DSM-IV, SCAN (general psychopathology) and SCID-II (personality disorders). Criteria for hypochondriasis from ICD-10 and illness anxiety disorder/somatic symptom disorder from DSM-5 are used for subcategorising. Dimensions and traits of personality are assessed by the questionnaire PID-5 included in DSM-5, section III. Outcome measures: The primary outcome measure is the questionnaire for health anxiety, Whiteley Index 7 (WI-7), with a cut-off for remission on 21,4 or a blinded diagnostic assessment of no severe health anxiety present 6 months after end of treatment. The secondary outcome measures are questionnaires for health anxiety (HAI), general psychopathology (SCL-90-R), level of personality disorders (PID-5), level of functioning (SF-36), quality of life (WHO-5, EQ-5D), Illness perception (IPQ), alcohol consumption (CAGE) and register data for number of sick days and use of social and health care and a blinded global assessment of functioning (F-GAF). Time frame: Data wil be analysed, and results wil be disseminated from 2016.
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.
The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy. The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development. IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.
Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs intermittent bladder catheterization after surgery, as they are transient incapable of voluntary bladder emptying (postoperative urinary retention - POUR). The currently used interventional threshold for urinary bladder catheterization are a bladder volume of approximately 500 ml., but no evidence exists for this threshold. At the same time, the current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in humans, and as the use of urinary bladder catheterization are increasing the risk of complications, the investigators are hypothesizing that increasing the interventional threshold for urinary bladder catheterization after fast-track total hip or knee arthroplasty, will reduce the number of patients needing urinary bladder catheterization, without increasing the incidence of urological complications - including urinary tract infections.
The objective is to study the cognitive functions in patients with chronic obstructive lung disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy controls. The cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. Driving simulations is used to test the cognitive functions. The hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.