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NCT ID: NCT03167060 Completed - Migraine Clinical Trials

BrainCool-Migraine Intranasal Cooling Trial

Start date: May 8, 2017
Phase: N/A
Study type: Interventional

This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal evaporative cooling device (the RhinoChill intransal device) in providing relief of pain and symptoms of acute migraine.The treatment works by introducing cooling into the passageways of the nose through two small cannulas thereby cooling the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. In total, 90 patients randomised in a 1:1 fashio n will be recruited from three different NHS Trusts. The patients will have a 30-day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 3 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments, if indicated.

NCT ID: NCT03166735 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH

Start date: June 6, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.

NCT ID: NCT03166007 Completed - Multiple Sclerosis Clinical Trials

Abdominal Massage for Bowel Dysfunction

AMBER
Start date: June 2014
Phase: N/A
Study type: Interventional

The aim of the AMBER trial is to determine the effectiveness and cost effectiveness of abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who have problems with their bowel i.e. faecal incontinence and/or constipation.

NCT ID: NCT03165240 Completed - Clinical trials for Diabetic Nephropathies

This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated

Start date: October 5, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB]. Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].

NCT ID: NCT03165201 Completed - Clinical trials for Liver Transplantation

Non-Invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan

RADIcAL2
Start date: September 18, 2017
Phase:
Study type: Observational

This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver transplant recipients, designed in accordance with the STARD criteria. Study participants are 200 patients with liver transplant, due to undergo liver biopsy as part of serial evaluation of their liver health and to rule out rejection. The whole study will take 3 years with 2 years of recruitment The main aim is to investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.

NCT ID: NCT03164876 Completed - Schizophrenia Clinical Trials

Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.

Start date: April 20, 2017
Phase: Phase 1
Study type: Interventional

This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.

NCT ID: NCT03164031 Completed - Multiple Sclerosis Clinical Trials

Feasibility and Acceptability of Orthotic Shorts for People With Multiple Sclerosis

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

Walking can be slow and unsteady in people with multiple sclerosis (MS). This study will investigate whether orthotic shorts might help. Orthotic shorts are similar to the tight clothing believed to improve performance in athletes. Research suggests that such shorts help stroke survivors to walk faster. Some people with MS find that similar garments improve coordination and stability. Public funding is controversial because there is no research investigating whether they work in people with MS. This is a cross-over study in which participants will each trial two different pairs of shorts. The first aim is to determine whether these shorts are acceptable to people with MS. Secondly, the study will develop the tools required to test the shorts. For example, by determining which measures seem most appropriate and if specific factors predict whether the shorts might help. The hypothesis being tested is that the shorts are acceptable. People with MS will be invited to participate in this mixed methods study, aiming for a sample size of 16 people. Participants will trial two different pairs of shorts, one of which will fit more closely than the other. The shorts will be tested in a movement laboratory and in daily life. In the movement laboratory, participants will be measured in both pairs of shorts and in normal, loose clothing. Walking pattern, speed and variability will be measured when the shorts are first worn. Participants will test shorts in their normal daily life for up to two weeks. They will complete questionnaires about their walking and balance in the different shorts and record how long they wear the shorts. Interviews will explore expectations and experiences of the shorts and of the research study. In the analyses, data from interviews will be combined with the numerical information gained from laboratory measures, diaries and questionnaires. If the shorts are acceptable, this study will inform a larger trial investigating effectiveness.

NCT ID: NCT03163446 Completed - Clinical trials for Staphylococcus Aureus Bacteremia

Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

Start date: May 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia. CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

NCT ID: NCT03162874 Completed - Parkinson Disease Clinical Trials

Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients

AMBLED
Start date: July 4, 2017
Phase: Phase 2
Study type: Interventional

This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

NCT ID: NCT03161561 Completed - COPD Clinical Trials

Mechanisms and Impact of Bacterial Colonisation in COPD

Start date: November 16, 2011
Phase: N/A
Study type: Interventional

COPD is a leading cause of lung disease and a common cause of hospitalisation, time off work and death. Smoking is the major factor associated with development of COPD. Nevertheless why some people develop COPD while others, including many smokers do not, is poorly understood. A central feature of COPD is accumulation of a particular type of white blood cell, the neutrophil, which is a key component in defence against bacterial infection in the lung airway. As disease progresses the small airways of many patients with COPD start to accumulate bacteria, which are normally lacking in the small airways of healthy individuals or smokers who lack COPD. The accumulation of bacteria in the smaller airways of many patients with COPD may be important to the development of the disease. Researchers will test if blood cells, which normally ingest and kill bacteria, have a reduced ability to perform this function in patients with COPD and whether the clearance of these blood cells after they have performed their role in protecting against infection is impaired. Researchers will relate these findings to the clinical features of COPD in a well-defined group of patients who have had extensive characterisation of their disease. In particular, researchers will relate this defect to the presence of frequent flares of disease, which lead to symptoms of wheezing and shortness of breath. Comparison will be made between blood cells obtained from the lung and from he blood to determine if the alterations are specific to the lung. Researchers will identify particular molecular alterations in the way these blood cells respond to bacteria and determine whether they can correct these alterations using agents, which are used to treat a range of different medical conditions, but which they predict might correct these alterations in function. The aim of this programme of work is ultimately to identify new ways in which to treat COPD and the agents, which the researchers demonstrate have the greatest potential to correct the abnormalities in cell function of patients with COPD, would in the future be studied in clinical trials.