Clinical Trials Logo

Filter by:
NCT ID: NCT03809871 Enrolling by invitation - Biomarkers Clinical Trials

Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

Participants who have signed up to the Watford Football Club Community and Education Trust Weight management programme called Shape Up will be approached to see if they would like to take part in this research study. Their participation in the Shape Up programme will not be affected if they do not choose to opt in to the research component. Fifty participants will be recruited and randomised in to one of two groups. One group will be the control group and they will undertake the Shape Up programme as normal and will be asked to complete some questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will be asked to complete the same questionnaires and will also have a venous blood sample taken at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar, vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor in layman terms on these results a week later and will have access to their data on an online portal set up by Medichecks. The weight management programme is based on a behaviour change programme where the participants attend a 90-minute session for 12 weeks, and they are then supported for another 12 weeks following the end of the supervision. The participants have weight and BMI measured at week 1, 12 and 12 weeks follow up. Each session consists of an education component followed by an exercise component. Initially, the education part is longer and the exercise is shorter, but as the programme progresses the education part becomes shorter and the exercise longer. The education programme includes topics such as healthy eating, increased physical activity and stress. The exercise programme includes whole body activities such as circuit training as well as other group exercise such as football. The questionnaires will include The Treatment Self-Regulation Questionnaire which will identify the motivation behind the participants' health. A general health questionnaire which is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12- item Short Form (SF12) which measures emotional quality of life. Physical activity will be measured through the short Active Lives Questionnaire. All these questionnaires have been attached as appendices. All participants will complete an exit telephone interview from the study to determine qualitative feedback on their experience of the study and to explore whether the biomarkers influenced their motivation to change their lifestyle. Some example questions have been attached. This is just a feasibility study, therefore no hypothesis testing will be undertaken.

NCT ID: NCT03809845 Active, not recruiting - Clinical trials for Motor Neuron Disease

Serial Fasciculation Measurements in Motor Neurone Disease

Start date: July 6, 2017
Phase: N/A
Study type: Interventional

Patients with motor neurone disease (MND) typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery. Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. We predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual. In order to calibrate this technique, we will conduct a 12-month longitudinal study, recruiting 24 patients from the King's College Hospital Motor Nerve Clinic, comprising a mixture of patients with MND and those with benign fasciculation syndrome. Patients in this latter group have fasciculations but do not develop weakness and have normal lifespans. They are therefore an optimal control group. At each visit, we will take resting HDSEMG recordings from all four limbs and perform standard clinical measures of disease progression. We will also monitor the decline in motor unit number using a newly validated neurophysiological technique, called Motor Unit Number Index (MUNIX).

NCT ID: NCT03809559 Active, not recruiting - Liver Diseases Clinical Trials

Repeatability and Reproducibility of Quantitative MRCP

Start date: July 19, 2018
Phase:
Study type: Observational

This study aims to determine the repeatability and reproducibility of Quantitative Magnetic Resonance Cholangiopancreatography (MRCP). Imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This enables advanced quantitative measurement of bile duct width, orientation, branching point and curvative metrics. The technology has been validated against 3D printed phantoms for accuracy, and early clinical research has demonstrated the technology has potential for clinical impact, with improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal et al 2017). Quantitative MRCP aims to act as a tool to not only improve assessment of the current status of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it must be established that any change between scans is due to change in the physiology of the individual and not due to a quirk or fault of the technology. In order to achieve this a series of scans will be performed on an individual over a short period of time, for which the condition of the biliary tree within that individual can be assumed to be constant. Between each scan, subject and coil repositioning will occur. The study will recruit a group of adult volunteers, from both diseased groups and healthy groups in order to achieve a range of physiological biliary metrics.

NCT ID: NCT03809494 Not yet recruiting - Clinical trials for Critical Limb Ischemia

HemaTrateā„¢ in the Treatment of Critical Limb Ischemia

Start date: January 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the performance of the HemaTrateā„¢ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.

NCT ID: NCT03809377 Not yet recruiting - Cancer Clinical Trials

Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects (RTGene 2)

Start date: April 1, 2019
Phase:
Study type: Observational

Peripheral blood samples will be taken with informed consent from radiotherapy patients before and during treatment fractions for sarcoma, breast, lung, gut, genitourinary and head & neck tumours at The Royal Marsden. Candidate genes identified by PHE, Columbia and/or in the literature as being specific to radiation responses will be assessed, together with genes relevant to systemic inflammatory and immune responses, to identify transcriptional responses for a range of doses and exposures on an inter-individual basis. Data will be analysed using existing and new statistical tools focused on count data modelling. The intended outcome is identification of a radiation specific panel of genes to inform individual radiation responses and if the results are favourable, a large scale follow up to this project is expected.

NCT ID: NCT03809325 Recruiting - Schizophrenia Clinical Trials

A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

Start date: November 21, 2018
Phase:
Study type: Observational

The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

NCT ID: NCT03809052 Not yet recruiting - Clinical trials for Safety and Tolerability

A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GB1211 in Healthy Subjects and in Subjects With Suspected Non-Alcoholic Steato-Hepatitis (NASH) and Liver Fibrosis

Start date: January 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult subjects with indication of suspected Nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT03809039 Recruiting - Healthy Clinical Trials

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects

Start date: January 15, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects.

NCT ID: NCT03808636 Recruiting - Tuberculosis (TB) Clinical Trials

Innovative Reagents for Improving Rapid Diagnosis of Mycobacterial Infections

TIKA_TB
Start date: June 2015
Phase:
Study type: Observational

The purpose of this study is to quantitate the speed of new culture method using 'Tika' media and compare with conventional systems

NCT ID: NCT03808402 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS

OPTISURF
Start date: October 26, 2018
Phase:
Study type: Observational

A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes.