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NCT ID: NCT03135899 Completed - Asthma Clinical Trials

BI 443651 Methacholine Challenge

Start date: May 18, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to investigate safety and tolerability of three consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651 administered via oral inhalation in male and female mild asthmatic subjects after a bolus methacholine challenge.

NCT ID: NCT03135808 Completed - Clinical trials for Sigmoid, Sigmoid Colon, Neoplasm, Cancer

Surgical Anatomy and 'Waisting' of the sIgmoid SpEcimen

WISE
Start date: May 18, 2017
Phase:
Study type: Observational

Treatment of rectal cancer has improved to the extent that its local recurrence rates are now much lower than other sites in the large bowel. It has been found that higher rates of recurrence in the sigmoid section of the colon, just before the rectum. This might be due to a narrowing in the bowel, and difficulties identifying whether cancers are in the sigmoid or rectum. The aim is to investigate the bowel from 20 patients undergoing surgery for left sided colorectal cancer at the Royal Marsden. These patients would have routine investigations and treatments, but once the bowel has been removed, it would undergo a MRI scan and additional slices and photography during pathological analysis.

NCT ID: NCT03135002 Completed - Clinical trials for Cardiovascular Diseases

The Leicester City and County Chronic Kidney Disease Cohort

LCC-CKD
Start date: January 10, 2017
Phase:
Study type: Observational

Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is independently associated with increased cardiovascular (CV) disease risk. This risk increases as CKD advances both in relation to worsening glomerular filtration rate and development of proteinuria. The overall cost of CKD to the NHS (National Health Service) in England has been estimated as £1.45 billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and strokes related to CKD. The epidemiology of CKD in primary care is poorly studied. This is particularly the case in non-white populations who have an independent higher risk of progression to end stage renal failure (requiring dialysis or transplantation), CV events and death. Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores. However, all the risk scores had significant methodological limitations, such as a lack of external validation or the perception that they were not 'clinically useful'. The Leicester City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP (general practice) records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years follow-up to the present day. In addition, a present day cohort will be created to both aid research and provide data for practices and clinical commissioning groups for quality improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort. The principal objectives of the study are: 1. To study the natural history of CKD in a multi-ethnic primary care setting 2. To contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD The risk prediction tool would more accurately stratify risk of CV events for individuals with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing the risk of future myocardial infarctions and strokes. Currently, individuals with CKD, despite higher risk of CV disease, may not be receiving optimum treatment such as statins and anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is likely to see a reduction in CKD associated excess CV events and their associated costs, including longer average duration of inpatient admissions.

NCT ID: NCT03134963 Completed - Alzheimer Disease Clinical Trials

Cerebral Haemodynamic Changes During Cognitive Testing: A fTCD Study

Start date: May 5, 2017
Phase:
Study type: Observational

850,000 people live with dementia in the UK, with that number expected to rise to more than 1 million within the next 5 years. The most common type of dementia (55%) is Alzheimer's dementia, and vascular dementia is the second commonest type (15%). Mild cognitive impairment (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a specific medical condition or disease. A person with MCI has subtle problems with one or more of the following: day-to-day memory, concentrating, planning or organising, language (eg struggling to find the right word), and judging distances and seeing objects properly. Although MCI significantly increases the risk of developing dementia (by up to 5 times), at present it is not possible to accurately predict which patients with MCI will progress to dementia. In recent times there has been an increasing awareness that problems with brain blood flow may contribute to the development, or progression, of dementia. Tests of mental abilities, with standardised questions and pen-and-paper tests are a key component of the formal diagnosis of dementia, yet little is known of the effects of these tests on brain blood flow. Brain blood flow can be can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery). This proposed study will therefore use TCD to evaluate changes in brain blood flow during performance of the Addenbrooke's-III (ACE-III) cognitive assessment in four key groups of patients, specifically: 1. Healthy older adults 2. Patients with mild cognitive impairment (MCI) 3. Patients with vascular dementia 4. Patients with Alzheimer's dementia

NCT ID: NCT03133871 Completed - Vitiligo Clinical Trials

Evaluation of Scanoskin for the Assessment of Vitiligo

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

The aim of this study is to establish whether the use of a special digital camera (SIAscopy) can provide an accurate and reliable measure of vitiligo which is at least equivalent to the current gold standard of planimetry. If so, SIAscopy could be used as an objective diagnostic and prognostic tool in the management of vitiligo patients within dermatology departments and allow a fair and accurate assessment of new potential treatments.

NCT ID: NCT03133689 Completed - Clinical trials for Coronary Heart Disease

Alcohol Consumption and Coronary Heart Disease Onset

Start date: March 1, 2017
Phase: N/A
Study type: Observational

The primary aim of this study is to examine if long-term patterns of alcohol consumption are associated with time-to-onset for incident coronary heart disease (fatal and non-fatal), using data from multiple cohorts.

NCT ID: NCT03133468 Completed - Clinical trials for Healthy Participants

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

Start date: July 25, 2017
Phase: Phase 1
Study type: Interventional

This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.

NCT ID: NCT03133377 Completed - Clinical trials for Critically Ill, Mechanically Ventilated

Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

TEAM(III)
Start date: February 28, 2018
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The effect of the intervention on mortality, physical, cognitive and psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes. The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.

NCT ID: NCT03132077 Completed - Clinical trials for Total Knee Arthroplasty

Analysis of Patient Outcome Questionnaire Following Primary Knee Replacement

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

The intention is to explore whether there are factors which help us to understand why some patient outcomes are not successful and identify prediction factors for progression. It will also assess the available outcomes pre- and post-surgery may explore prediction tools for good/poor progression and improve the patient's selection, patient preparation or timing for surgery. The focus of this project is exploring outcomes post-primary total knee arthroplasty (TKA) using the available pre/post-operative Oxford Knee Score (OKS), University of California Los Angeles (UCLA) Activity Score, EQ-5D General Health Questionnaire, Visual Analogue (VAS) for pain, age and smoking status data, and correlations between these data and post operation patient satisfaction.

NCT ID: NCT03131960 Completed - Clinical trials for Upper Extremity Paresis

Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)

VNS-REHAB
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (<30, >30) and baseline FMA UE (20 to <35; >35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.