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NCT ID: NCT03360032 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Comparing Measurements Made in an Incremental Shuttle Walk Test and a Cardiopulmonary Exercise Test in Patients With IPF

Start date: January 10, 2018
Phase:
Study type: Observational

Idiopathic pulmonary fibrosis (IPF) is a chronic and potentially fatal lung disease. As IPF progresses, patients become increasingly breathless with reduced exercise capacity and quality of life. A cardiopulmonary exercise test (CPET) is a gold standard way of assessing patients with IPF. An incremental shuttle walk test is simpler, cheaper, more widely available and anecdotally preferable to CPET. The investigators will compare the measurements made in an ISWT and a CPET in patients with IPF . We aim to determine whether sufficient information can be gathered in an ISWT to negate the need to undertake CPET.

NCT ID: NCT03351972 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Differences in Preparation for Small Bowel Capsule Endoscopy

Start date: November 23, 2017
Phase: Phase 4
Study type: Interventional

The introduction of video capsule endoscopy in 2000 has provided a convenient and minimally invasive imaging method for the whole small bowel. Capsule Endoscopy is used to investigate a number of conditions such as obscure gastrointestinal bleeding, iron deficiency anaemia, inflammatory bowel disease, celiac disease, small bowel tumors, and hereditary polyposis syndromes. However, Capsule Endoscopy capsules are not able to suction fluid or wash the intestine, thus making it susceptible to decreased visualization quality and diagnostic yield due to dark intestinal contents or air bubbles. In order to determine the best method for bowel preparation before Capsule Endoscopy, this study seeks to determine in patients undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the aggregate of all the active preparation groups compared to than clear fluids only group. Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel examination by time) and small bowel transit time (measured as time from first duodenal image to first cecal image). Adult outpatients referred for small bowel video capsule endoscopy will be considered for the study and this will run in the clinical environment as per routine. Patients will have been referred for capsule endoscopy as per normal clinical practice so not additional procedure will take place. Patients will be randomly assigned to in a one to one fashion to one of three groups in order to explore whether bowel preparation (either as a single or divided dose) produce better cleansing and diagnostic yield than no preparation at all in small bowel capsule endoscopy.

NCT ID: NCT03344133 Recruiting - Clinical trials for Overweight and Obesity

Effect of Exercise Programme on Gut Microbiota, CVD Risk Factors and Appetite Regulation in Overweight Women

Start date: September 16, 2015
Phase: N/A
Study type: Interventional

Evidence suggests that gut microbiota contributes to the development of atherosclerosis and therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to modification of body fatness, metabolic risk factors and cardio-respiratory fitness. It remains unclear whether impact of exercise on CVD risk can be at least in part explained by changes in the microbiota. It also remains to be investigated whether modification of appetite and appetite hormones due to participation in exercise are related to changes in the gut microbiota composition. Therefore, this study will be conducted in overweight, healthy, sedentary women and will investigate the effect of a 4-week moderate intensity exercise programme on gut microbiota composition and metabolic activity, plasma concentrations of fasting and postprandial lipids, glucose, insulin and inflammatory markers, fasting and postprandial gut appetite hormones, subjective appetite measures and cardio-respiratory fitness.

NCT ID: NCT03339128 Recruiting - Clinical trials for Irritable Bowel Syndrome

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

Start date: November 15, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.

NCT ID: NCT03337074 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Paternally Inherited Phenotypes in Cholestasis

PIP-C
Start date: February 8, 2017
Phase:
Study type: Observational

For some years investigators have known that the health of fathers at the time their baby is conceived has an influence on the health of their child in the future. Many studies looking at this effect have investigated fathers with obesity and other metabolic disorders. These disorders can alter the risk of obesity and diabetes in the children of these men. More recently, studies have been undertaken to establish the mechanism by which this risk is inherited by the children. Studies of sperm have identified that changes in the structure and function of the sperm play a role. Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC) are included in a group of cholestatic liver disorders that are associated with elevated levels of bile acids in the blood (cholestasis). A previous study has established that children born to women who have cholestasis during pregnancy are at an increased risk of obesity later in life. Our study will investigate whether there is a similar effect on the health of children if their father has cholestasis. The study has 2 arms, the Sperm Epigenome arm and the Outcomes arm. In the Sperm Epigenome arm of the study, the structure and function of sperm from men with PSC, PBC and other cholestatic liver disorders will be investigated and compared to the structure and function of sperm from healthy men. In the Outcomes arm of the study, basic health parameters of fathers who had PSC, PBC or another cholestatic liver disease either before or after their child was conceived will be studied. Basic health parameters will also be studied in their child when the child is between 16 and 25 years of age.

NCT ID: NCT03334292 Recruiting - Wilson Disease Clinical Trials

Natural History of Wilson Disease

Start date: December 18, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of the registry/repository is to provide a mechanism to store data and specimens to support the conduct of future research about Wilson disease (WD). The overall aim is to determine the optimal testing for diagnosis and parameters for monitoring treatment of WD that will aid product utilization and development.

NCT ID: NCT03326336 Recruiting - Clinical trials for Non-syndromic Retinitis Pigmentosa

Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

PIONEER
Start date: September 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa

NCT ID: NCT03325582 Recruiting - Perianal Fistula Clinical Trials

MR Assessment of Perianal Crohn's Disease

MAP
Start date: April 21, 2017
Phase:
Study type: Observational

Perianal Crohn's disease (pCD) is the commonest form of fistulising Crohn's disease, with up to 38% of patients affected and with 30% of them experiencing recurring disease symptoms. Presence of fistula can lead to major morbidity due to cutaneous perianal abscess formation or drainage. To date, it is very difficult to quantify inflammation in patients with pCD due to the absence of reliable disease activity measurements. In addition to this, optimising therapies for pCD is quite challenging and may have a major impact on quality of life. Magnetic resonance imaging of pelvic is a standard examination for the anatomical evaluation of pCD which is significant in terms of surgical therapy and progress. The overall hypothesis is that newer MRI techniques such as magnetization transfer (MT), diffusion weighted image ( DWI) and dynamic contract enhancement (DCE) are better suited to measuring the inflammatory vs fibrotic burden in pCD. The aim of this project is to measure disease activity within pCD and luminal CD using MRI sequences before and after biological therapy

NCT ID: NCT03323957 Recruiting - Malnutrition Clinical Trials

Development and Evaluation of a New Infant Nutrition Screening Tool

iNEWS
Start date: October 1, 2010
Phase: N/A
Study type: Observational

A large number of children experience undernutrition related to or resulting from their illness. The NHS has recently published standards which state that all patients should be screened for undernutrition on admission and periodically during their stay at hospital. Although, recent studies have attempted to develop appropriate nutritional screening tool for children on admission, there is no agreement concerning the most appropriate criteria to be used and they have not been validated for use in infants. The project team have developed a preliminary tool that would be both simple and quick to use in order to identify infants who are either undernourished or at risk of undernutrition on admission and who would benefit from referral for full nutritional assessment by a dietician. The purpose of this study is establish whether an infant Paediatric Yorkhill Malnutrition Score for infants would be able to distinguish infants who are well-nourished from those undernourished or at risk of undernutrition. The researchers will recruit all newly admitted patients ( 210 infants with low, medium, and high risk of undernutrition) from selected wards at the Royal Hospital for Sick Children Glasgow. The result from the infant screening tool will be compared with the rating using the longer Subjective Global Nutritional Assessment to test the ability of Infant Screening Tool to identify infants at high risk of malnutrition. The researcher will also measure the fat store using skinfolds and will compare the results among those rated high or low risk by the new tool. Finally, the utility of iPYMS score, growth trajectory, body mass index and behaviour questionnaire as predictors of low adiposity and stunting will be compared.

NCT ID: NCT03320382 Recruiting - Asthma Clinical Trials

Multiple Breath Washout, a Clinimetric Dataset

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

Monitoring patients with chronic, inflammatory airways disease particularly in the early stages is hampered by the relative insensitivity of current outcome measures to detect subtle changes. Multiple breath washout is a potential sensitive test that is a useful readout of disease at these early stages but it lacks standardisation and knowledge of variability with reference to standard lung function measures. This is a Cross sectional and longitudinal observation study. The hypothesis is that multiple breath washout-derived indices will provide a robust signal of gas mixing inhomogeneity, correlating with conventional measures of airway disease severity. Multiple breath washout performed on different devices will generate indices which correlate but differ in value.