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NCT ID: NCT02255591 Completed - Pain, Postoperative Clinical Trials

Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus

Start date: February 2015
Phase: Phase 4
Study type: Interventional

The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers. Secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy volunteers. The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound technique, and that the success rate of the Shamrock technique is equal to or higher than the Lumbar Ultrasound Trident technique.

NCT ID: NCT02255422 Completed - Clinical trials for MItochondrial Myopathies

RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

Start date: May 5, 2015
Phase: Phase 2
Study type: Interventional

Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a wide range of biochemical and genetic mitochondrial defects and variable modes of inheritance. Currently there are no effective treatments for this disease. Despite the heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that the pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP), often resulting in muscle weakness, exercise intolerance, and fatigue in patients with mitochondrial myopathies. RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can increase mitochondrial respiration and biogenesis. Collectively, available data suggest that the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially improve muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial biogenesis in patients with mitochondrial myopathies. This study will be a randomized, placebo-controlled, double-blind, dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in patients with mitochondrial myopathies.

NCT ID: NCT02255019 Completed - Clinical trials for Inflammatory Bowel Disease

MRI in Patients With Inflammatory Bowel Disease

Start date: May 2011
Phase: N/A
Study type: Observational

The aim of this study is to find an optimal magnetic resonance imaging (MRI) method to examine patients with inflammatory bowel disease (IBD). Patients should furthermore avoid being exposed to unnecessary X-rays and invasive examination. It is the investigators expectation that this study will benefit to future patients, as they will be offered MRI as the first choice. Hereby, the patients avoid the risks and discomfort associated with x-ray examinations. The aim is that patients with IBD achieve better and earlier treatment and if this is achieved it both benefits patient and public health. An earlier treatment leads to fewer hospitalizations and thereby saving the community money. The investigators hope is that the investigators study will show that MRI is one of the best tool to examine patients with IBD and that this in future leads MRI to be the first choice in contrary to all examinations with x-ray exposer, unless there is any contraindication to MRI.

NCT ID: NCT02254967 Completed - Clinical trials for Clostridium Difficile

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

EXTEND
Start date: November 6, 2014
Phase: Phase 4
Study type: Interventional

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

NCT ID: NCT02254499 Completed - Knee Osteoarthritis Clinical Trials

Prediction of Pain After Total Knee Arthroplasty

Start date: September 2014
Phase: N/A
Study type: Observational

Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.

NCT ID: NCT02253966 Completed - Hyperalgesia Clinical Trials

Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.

NCT ID: NCT02253082 Completed - Clinical trials for Endothelial Dysfunction

Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)

VIPER-OCTA
Start date: November 2014
Phase: Phase 4
Study type: Interventional

Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial

NCT ID: NCT02253004 Completed - Stroke Clinical Trials

Induction of Migraine Aura With Cilostazol

Start date: September 2014
Phase: Phase 0
Study type: Interventional

In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.

NCT ID: NCT02252926 Completed - Mucositis Clinical Trials

Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Start date: September 2014
Phase: Phase 2
Study type: Interventional

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects. Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.

NCT ID: NCT02251418 Completed - Diabetic Foot Ulcer Clinical Trials

Shockwave Therapy of Chronic Diabetic Foot Ulcers

Start date: February 2015
Phase: N/A
Study type: Interventional

Introduction: Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations. Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown. Purpose: The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers. Hypothesis: The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects. Method: Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for infection at every consultation, and a swab sample will be collected at enrollment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview. Significance: ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.