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.
Trial The aim of the study is to investigate which infectious diseases might mimic the symptoms of acute appendicitis to a degree to cause a diagnostic laparoscopy or laparoscopic appendectomy. The primary outcome is to compare the incidence of Yersinia spp. infection in patients, who undergo surgery due to suspected appendicitis, between those with and without appendicitis detected by polymerase chain reaction on rectal swabs. The secondary outcomes are comparison of the incidence of bacterial pathogens (Campylobacter spp., Salmonella spp., Shigella spp., Aeromonas spp.) and Enterobius vermicularis in the two groups. Rectal swabs, appendix swabs, and blood samples are collected prospectively and research biobanks will be established. Initially, the rectal samples and serology samples will be investigated, and possible biomarkers and results of the appendix swabs will be evaluated at a later time point. Ethics The trial will be conducted according to the Helsinki II Declaration after approval from both the local Health Research Ethics Committee and the Danish Data Protection Agency. An informed written consent will be collected from the participants prior to inclusion in the study. Data will be stored according to the approval from the Danish Data Protection Agency. This study is conducted in patients with suspected appendicitis. These patients are fully awake and conscious at time of inclusion. The patients included in this study will not experience any adverse effects due to their participation.
This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight compensated patients with an ileostomy and not on home parenteral Nutrition or fluid support.
The aim of this study was to investigate the feasibility and efficacy of a high intake of milk and/or cheese products compared to phosphate tablets in patients with hypophosphatemic rickets when evaluating the S-phosphate levels as a main effect parameter. The study was designed as a randomized, multiple crossover study.
Familial adenomatous polyposis (FAP) is an autosomal dominant genetic disorder that predisposes to a number or malignant disorders [1,2]. Clinically, FAP presents with an abnormal number of colorectal polyps (100-5000), while it genetically is defined by mutations in the APC-gene [1]. Historically, colorectal cancer has been the major cause of deaths for FAP patient. However, as the incidence of colorectal cancer has decreased with the use of prophylactic colectomy, the incidence of duodenal cancer has increased [3,4]. It is estimated that the cumulative lifetime risk of duodenal polyposis exceeds 95% [1,5]. The predictor of duodenal cancer is duodenal polyposis, which is almost inevitable in patients with FAP. In 1989 the Spigelman score was introduced in order to assess the severity of duodenal polyposis and stratify patients according to risk of duodenal cancer (Table 1) [6]. It is a composite score that includes two endoscopic parameters (number and maximum size of polyps, respectively) and two histopathological parameters (histological subtype and grade of dysplasia). The score ranges from 0-12 and it has been classified in four stages. The 10-year risk of developing duodenal cancer corresponds with the Spigelman stage ranging from ≈0 for stage 0-1 to 36% for stage 4 [7]. Besides duodenal cancer, the indications of cancer prophylactic surgical resection are debatable, but generally recommended in the case of Spigelman stage 4 or high-grade dysplasia. Table 1 Spigelman Classification for duodenal polyposis Criterion 1 point 2 points 3 points Polyp number 1-4 5-20 >20 Polyp size (mm) 1-4 5-10 >20 Histology Tubular Tubulovillous Villous Dysplasia Low grade* High grade* Stage 0: 0 points; stage I: 1-4 points; stage II: 5-6 points; stage III: 7-8 points; stage IV: 9-12 points. *Originally, 3 grades of dysplasia were incorporated. While the correlation to cancer has been explored in several studies, the validation and the reproducibility of the Spigelman score remains somewhat unclear. The primary aim of this study is to assess the inter- and intra-observer agreement of the Spigelman score for experienced endoscopists using state-of-the-art high-definition (HD) endoscopes. Hypothesis: The Spigelman score has perfect reproducibility for endoscopic experts (κ>0.80 with 95% CI.).
The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.
This study investigates the agreement between extended scope physiotherapists (ESP) and orthopaedic surgeons (OS) on diagnosis and treatment plan in an orthopaedic outpatient shoulder clinic. Furthermore a cost analysis and an evaluation of the interdisciplinary collaboration at the orthopaedic outpatient shoulder clinic (termed shoulder clinic in the following) will be performed.