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NCT ID: NCT03439566 Completed - Pain, Postoperative Clinical Trials

Does Preoperative Pain Levels by Venipuncture Predict Late Postoperative Pain Levels?

Start date: January 15, 2018
Phase:
Study type: Observational

This study wishes to investigate if pain by peripheral venous cannulation (PVC) preoperatively, will predict pain levels after 24 h postoperatively. Furthermore, to investigate moderate/severe pain at the postoperatively at the post-anaesthesia care unit (PACU) is associated with increased late (24h) pain. Additionally, if the PACU nurse is able to predict if the patient will be a high pain responder, by using a clinical judgement. Finally to evaluate the patient's pain-levels at home after discharge and investigate for associations between postoperative pain and post-discharge pain.

NCT ID: NCT03439241 Completed - Ileostomy - Stoma Clinical Trials

Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy

Start date: February 5, 2018
Phase: N/A
Study type: Interventional

The purpose was to investigate the performance of a new ostomy device measured with a measuring device.

NCT ID: NCT03438916 Completed - Liver Cirrhosis Clinical Trials

MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis

Start date: April 1, 2017
Phase:
Study type: Observational

Background: Standardization and new therapeutic treatments of variceal bleeding has significantly reduced the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and 1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous administrations), the risk of bleeding is substantially reduced, but not all patients respond to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB should be offered alternative treatment with e.g. carvedilol, which is a combined alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few centres in the world can perform this procedure and there are no reliable non-invasive alternatives to assess the respond to NSBB, which is of extreme importance, since non-responders have three fold increased risk of a new variceal bleeding episode. Aim: In general the aim of the project is to develop faster and non-invasive methods to evaluate portal hypertension and individual pharmacological response of NSBB in patients with cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on portal pressure. Study design and patients: 39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment. Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the gold standard method to test if patients respond to propranolol treatment. At visit 1. the response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG< 12mmHg after intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.

NCT ID: NCT03438396 Completed - Cervical Cancer Clinical Trials

A Trial of Tisotumab Vedotin in Cervical Cancer

Start date: June 12, 2018
Phase: Phase 2
Study type: Interventional

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

NCT ID: NCT03437356 Completed - Atrial Fibrillation Clinical Trials

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

POWDER-AF2
Start date: February 26, 2018
Phase: N/A
Study type: Interventional

In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients). In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.

NCT ID: NCT03436901 Completed - Testicular Neoplasm Clinical Trials

Whole Body MRI With DWI for Monitoring Patients Treated for Testicular Cancer Stage II-III

TENY
Start date: February 19, 2018
Phase: N/A
Study type: Interventional

Testicular cancer (TC) affects approx. 1% of Danish men and is the most common cancer in men aged 15-35 years. It is the most curable solid cancer type with a 5-year survival rate of 90-95%. Staging and follow-up of these patients involve 5-10 CT scans of each patient, imposing a significant radiation burden: Approx. 3-5 of the 300 Danish patients presenting with TC each year are expected to develop a radiation-induced secondary cancer, half of which are expected to be fatal. MRI is rapidly developing and new WB-MRI can cover large parts of the body in a clinically realistic scan time. With this development, it is within reach to nearly eliminate the radiation burden by substituting the large amount of CT scans with MRI scans in TC. MRI is without any known risk of long-term side effects. Despite this, limited data exist on MRI used in follow-up of TC. At Aarhus University Hospital, we introduced MRI for the follow-up of TC stage I in 2008. We now want to evaluate the results of in this unique cohort of patients and evaluate in a prospective trial if the newest WB-MRI techniques can replace CT in patients with TC stage II-IV. To the best of our knowledge, no study has investigated how much it is possible to reduce the MRI scan time in patients with TC in order to develop a clinically realistic scan time while still maintaining an acceptable uncompromised diagnostic accuracy. The overall aim of this study is to reduce the risk of radiation-induced secondary cancers in patients operated diagnosed with TC by replacing CT as a follow-up imaging method with non-ionizing WB-MRI including DWI. We have these specific aims: - To study the ability of WB-MRI with DWI to replace standard CT in TC stage II-III patients in a prospective non-inferiority study. - To evaluate if it is possible to reduce scan time in the WB-MRI protocols in the TC stage II-III group while maintaining sufficient diagnostic accuracy in order to improve clinical application of the techniques.

NCT ID: NCT03435900 Completed - Clinical trials for Appendicitis Perforated

Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis

Start date: February 14, 2018
Phase: Phase 2
Study type: Interventional

The objective of this trial is to evaluate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) followed by oral antibiotic for three days is as effective as the current intravenous antibiotic treatment given during and three days after appendectomy for perforated appendicitis. The primary outcome is the total length of hospital stay, defined as the number of hours in hospital after end of operation and until 30-day follow-up.

NCT ID: NCT03435016 Completed - Crohn Disease Clinical Trials

A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease. 1. Comparing imaging modalities: The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer healing after medical treatment in patients with symptomatic Crohn's disease compared to ileocolonoscopy. 1. Sensitivity and specificity for ulcer healing 2. Changes in activity parameters for SBCCE, MREC and US before and after medical treatment. 3. Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease. 2. Treatment induced bowel wall alterations visualized with ultrasound: 1. A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease. 2. Changes in bowel wall thickness, vascularity and elastography parameters, and time to normalization of the bowel wall.

NCT ID: NCT03427203 Completed - Ileostomy - Stoma Clinical Trials

Assessment of New Ostomy Devices in Subjects Having an Ileostomy

Start date: January 9, 2018
Phase: N/A
Study type: Interventional

The study investigates the performance of three new adhesives with regard to leakage and the skin condition.

NCT ID: NCT03426813 Completed - Pneumonia Clinical Trials

Early Mobilization of Patients With Community-acquired Pneumonia

Start date: October 2012
Phase: N/A
Study type: Interventional

Pneumonia is a common health problem.This thesis may clarify whether early mobilization influence the time these patients are hospitalized, whether they are rehospitalized and whether it is possible to reduce the mortality rate.