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NCT ID: NCT02209454 Completed - Acute Pain Clinical Trials

Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

Start date: April 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In addition, this study intends to evaluate the safety and tolerability of Test and Reference formulations.

NCT ID: NCT02209116 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

AQUA2
Start date: July 2014
Phase: N/A
Study type: Interventional

Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health disorders of childhood. Children with ADHD often have poor attention, are restless and hyperactive and show impulsive behaviour. It is important to detect ADHD so young people can have access to appropriate clinical interventions. One of the most common ways ADHD is assessed is through the clinician's opinionÍž however, this can vary between clinicians and is thought to be one reason why ADHD may be mis-diagnosed. Using a more objective computer tasks may help improve our understanding of ADHD. One computer task is the QbTest. The test presents different symbols to the child, and the child has to respond by pressing a button only when a target symbol appears. The test measures the child's attention, impulsivity and movement whilst doing this task. Although the test is thought to be a valid measure, more research needs to be conducted on this measure to see whether it helps clinicians decision making. To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication decisions, children and young people will be asked to complete the task as part of their initial assessment for ADHD. Half the participants and their clinician will have access to the QbTest resultÍž the other half will not have access to the QbTest result until the end of the study. Participant's parents, teachers and the clinician will also be asked to complete some questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD and is given medication they will be asked to complete the task again on medication. The same set of questionnaires will be completed by the parents/teachers/clinicians. The entire sample will be followed up at 6 months and asked to complete the questionnaires.

NCT ID: NCT02208817 Completed - Trauma Clinical Trials

The Paediatric Refill Study (PRefill)

PRefill
Start date: August 2014
Phase: N/A
Study type: Observational

2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies in recognising and managing sick children. Key recommendations from both reviews included the development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to better identify the sick or deteriorating child. PEWS tools offer the potential to identify and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of skin blood flow and is a vital part of many early warning and resuscitation scores. It is a sensitive marker of infection and dehydration in children. However, due to how it is performed and interpreted CRT is prone to marked variability between observers. We have Medical Research Council (MRC) funding to develop an automated capillary refill device and user interface to provide a paediatric continuous early warning (PaedCEW) monitoring system. The PaedCEW system would complement and support current clinical practice and aim to address the difficulties of recognising ill children. We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2 matched controls without significant illness from the Nottingham Children's Hospital. The 20 ill children will have their CRT (and PaedCEW score) monitored before, during and after admission to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations, lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status during periods of stability and compromise. Matched controls will be monitored for around 24 hours. This pilot study will allow development of our system. This is a proof of concept study. This study aims to demonstrate a novel device for measuring CRT. Its correlation with noninvasive measures of cardiovascular status will enable a pragmatic comparison with current clinical practice. In addition, correlation with invasive measures of cardiovascular status will enable us to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).

NCT ID: NCT02208778 Completed - Chronic Pain Clinical Trials

Imaging Pain Relief in Osteoarthritis

IPRO
Start date: December 2014
Phase: Phase 4
Study type: Interventional

Osteoarthritis (OA) is a degenerative joint disease and is the most common form of arthritis. Pain reduction and functional recovery are the key elements of the clinical management of OA. Current treatment guidelines recommend a combination of pharmacological and non-pharmacological treatments. However, these are not always effective, with nearly 20% of patients not responding to any standard therapy, including joint replacement. The mechanisms of pain relief are not well understood and are complicated by the remarkably large placebo effect, and inter-individual variation. There is no objective criteria for predicting whether a patient will respond to a given treatment Duloxetine, an antidepressant drug, has proven effectiveness in various chronic pain syndromes including knee OA. The effect is however limited and only clinically relevant in around half of the trial patients. Importantly, it is currently unclear how and in whom duloxetine alleviates chronic pain. Advanced MRI techniques use strong magnetic fields and radio frequency signals to generate metabolic, anatomical and functional brain images (fMRI). Remifentanil is a potent analgesic agent whose analgesic effect has been well characterised in healthy volunteers, including fMRI studies showing modulation of activation of regions in the brain related to pain processing. Nevertheless, the neural correlates of remifentanil effects have not yet been investigated in chronic pain patients. The aim of this research is to use a combination of multimodal MRI, genetic and psychometric assessments to identify the mechanisms of pain relief in knee OA patients, following treatments with duloxetine and remifentanil, in a placebo controlled condition. With this we also aim to identify genetic, anatomical and brain activity predictors of treatment outcomes. The main hypotheses are: - Analgesic response to duloxetine treatment can be predicted using a range of baseline brain imaging markers and QST. - Analgesic response to duloxetine is mediated by modulation of neural networks underpinning emotional control. - Duloxetine-induced changes in brain activation differ between responders and non-responders. This study is expected to last for two years. It is funded by Arthritis Research United Kingdom and forms part of a wider scientific investigation, using translational methodologies, to enhance the understanding of arthritis pain and to improve its treatment.

NCT ID: NCT02208648 Completed - Clinical trials for Peri-operative Mortality

Coronary Assessment for Mortality Prediction

CAMP
Start date: October 31, 2014
Phase:
Study type: Observational

The study will investigate whether the presence of coronary artery calcium as demonstrated on pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor for 90 day mortality in patients undergoing major abdominal surgery. The study research question: Do higher levels of coronary calcification correlate to an increased risk of post-operative mortality in patients undergoing major abdominal surgery?

NCT ID: NCT02208401 Completed - Bowel Cancer Clinical Trials

Randomised Comparison of 2 Cold Snare Polypectomy Techniques

Start date: January 2014
Phase: N/A
Study type: Interventional

Different modalities are employed to remove small colonic polyps which potentially harbour a cancer risk. But, they can all vary in their completeness of removal, safety and the histological quality and the gold standard technique has yet to be defined. A novel suction pseudopolyp technique has been described by Patullo et al and in their prospective study, 126 polyps measuring less than 10mm flat or sessile were removed by this method with 100% complete endoscopic resection and without any immediate or delayed complications. The aim of the investigators study is to compare this technique with the standard cold snare technique. Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size will be eligible and they will be randomised to the polypectomy technique. Patient demographics and polyp characteristics will be recorded. The primary outcome measured will be the macroscopic resection rate. The secondary outcome measures are abdominal pain, tenderness, bleeding and fever.

NCT ID: NCT02208154 Completed - Clinical trials for ICU-ecology (Multidrug Resistant Bacteria)

Ecological Effects of Decolonisation Strategies in Intensive Care

RGNOSIS
Start date: December 1, 2013
Phase: Phase 3
Study type: Interventional

Previous research has shown that applying certain treatments can reduce both the number of infections and the presence of resistant bacteria in the intensive care (ICU) and its patients. These treatments have been used as standard care throughout the world for many years, but they have not been compared to each other yet. The investigators aim to evaluate the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial infections in the ICU and to establish which treatment is the best. All adult patients undergoing mechanical ventilation are eligible for this study and will receive treatment according to the study scheme. Twice weekly, sputum and rectal samples will be obtained to measure the effects. All ICU-patients will receive standard treatment, consisting of daily body washing with an antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers as endorsed by the WHO. According to 4 different study periods, each participant will receive one of the following extra treatments depending on his or her admission date: - Standard treatment only (this is the control group) - Chlorhexidine 1% oral gel, this is an antiseptic. - Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal decontamination, SOD). - Antibiotic mouth paste and suspension for the stomach and intestines containing 3 different antibiotics (selective digestive decontamination, SDD). All treatments will be given 4 times daily with the purpose of killing harmful bacteria in the mouth (CHX, SOD,SDD) and digestive tract (SDD). During the study the investigators will examine the effect of these treatments on: - the occurrence of blood stream infections with certain bacteria - cross-transmission of certain bacteria between patients - presence of these bacteria in the respiratory tract of the patients - patient survival Benefits: Previous research has shown that these interventions can reduce infections in intensive care patients. Risks: The interventions performed (both cultures and treatment) are considered safe and are already given as standard care in many ICUs throughout the world. There is a slight risk that bacteria become resistant to antibiotics: this will be monitored closely during the trial.

NCT ID: NCT02208115 Completed - Clinical trials for Type 1 Diabetes Mellitus

Post-exercise Appetite Responses in Type 1 Diabetes

Start date: November 2013
Phase: N/A
Study type: Interventional

The investigators hypothesise that manipulating the glycaemic index of the meal after exercise will influence the acute appetite responses of Type 1 diabetes individuals

NCT ID: NCT02208089 Completed - Keratoconus Clinical Trials

Simultaneous TransPRK and Corneal Collagen Cross-Linking

TransPRKCXL
Start date: August 2014
Phase: N/A
Study type: Interventional

Young patients with keratoconus face two problems: disease progression and corneal shape irregularity leading to poor vision even in spectacles. Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression in keratoconus. The aim is to stiffen the cornea thereby preventing further shape deterioration. Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal shape irregularity in early stage keratoconus, reducing dependence on contact lenses. In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure, preparing the cornea for CXL. Performing both treatments simultaneously (combining both procedures in one operation) may offer several advantages over performing CXL first then waiting for corneal shape to stabilise before performing transPRK. In particular, visual rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients will be compared with results for a similar group of patients with early stage keratoconus who have already been treated with CXL alone.

NCT ID: NCT02207634 Completed - Dyslipidemia Clinical Trials

Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects

EBBINGHAUS
Start date: September 10, 2014
Phase: Phase 3
Study type: Interventional

This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.