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NCT ID: NCT02136381 Recruiting - Health Behavior Clinical Trials

Lifestyle Interventions at Retirement

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

The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition. Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Our assessment of the literature shows that interventions with people of retirement age can effectively promote components of the Mediterranean diet (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87: 2013). This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking place in the North-East of England. We have developed an internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1) healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use of a step-counter, and 3) improving social connectedness. Participants recruited for this study will be allocated in random order with a ratio of 2:1 to the intervention group (LEAP) or to a control group. This study will evaluate the feasibility and acceptability of the LEAP intervention among people of retirement age and will pilot trial procedures. In this programme of research we have also defined a suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability, Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of these measures has yet to be determined and therefore will be formally assessed in this pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical activity and social roles). The hypotheses to be tested in the LiveWell programme are as follows: - A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) is an acceptable tool for behaviour change among people of peri-retirement age. - A suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.

NCT ID: NCT02136277 Recruiting - Clinical trials for Patients Undergoing Open Resection of Colorectal Tumours

Vascular Changes During Colorectal Surgery

MaMiFlo
Start date: January 2015
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether increases in the blood flow from the heart (the cardiac output), induced by the administration of intravenous fluids, lead to an increase in the blood flow to the vital organs, in patients undergoing bowel surgery. This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the research fellow (medical doctor) undertaking this study, who will check their suitability to participate in the study and who will obtain informed consent. The second phase is the study itself which will take place whilst volunteers are having their bowel operation. They will attend theatre in the normal way, but once they have been anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in bowel surgery to help assess how much intravenous fluid to administer to a patient by measuring the cardiac output (the amount of blood pumped out of the heart each minute). Using the cannula (drip) already inserted in the arm to allow administration of the anaesthetic, a special fluid, called an ultrasound contrast agent, will be injected into the drip, to allow a contrast enhanced ultrasound scan of the abdominal organs to be performed, to measure the blood flow to these organs. A small sample of blood will be taken from the earlobe to allow us to measure a chemical in the blood called lactate. After this, intravenous fluid will be administered in order to increase the amount of blood pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate amount of fluid has been given, a second ultrasound scan will be performed to measure whether blood flow to the abdominal organs has also increased. A further blood sample will be taken from your earlobe to measure any change in lactate level. At the completion of the operation, a third ultrasound scan will be performed and another sample of blood taken from the earlobe, to help assess blood flow to the organs.

NCT ID: NCT02135705 Recruiting - Clinical trials for Homozygous Familial Hypercholesterolemia

LOWER: Lomitapide Observational Worldwide Evaluation Registry

LOWER
Start date: March 18, 2014
Phase:
Study type: Observational [Patient Registry]

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.

NCT ID: NCT02132741 Recruiting - Hypertension Clinical Trials

Optical Coherence Tomography And NEphropathy: The OCTANE Study

Start date: May 16, 2014
Phase:
Study type: Observational

Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.

NCT ID: NCT02128295 Recruiting - Clinical trials for Duration of Exclusive Breast-feeding

Trial of Two Electric Breast Pumps in Mothers of Term Infants.

Start date: June 2015
Phase: N/A
Study type: Interventional

This is a randomised trial of two modern single electric breast pumps allocated to mothers who are exclusively breast feeding their healthy term infants. Mothers will be recruited when their infants are around a month old, they will be randomised either to use one of two state of the art modern single electric breast pumps or to act as controls with no breast pump (but will receive a baby care voucher of similar value). If allocated to a breast pump, mothers will be asked to take part in a physiological study when their babies are 6 weeks old. In this test the mothers will be asked to express breast milk for 10 minutes on each breast. The primary hypothesis is that the total weight of milk produced in a 20 minute period and the weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers using one of the pumps. A small sample of breast milk (~5ml) will be collected for analysis, the remaining expressed milk will returned to the mother. Each month between the age of 3 and 6 months, all the mothers will be asked to complete online questionnaires about their breast-feeding and the use of their breast pumps (if they have one). At the end of the six months the mothers will be given a small voucher for a child-care store as a way of saying 'thank-you' for the inconvenience caused.

NCT ID: NCT02126800 Recruiting - Clinical trials for Metastatic Breast Cancer

Rapid Medical Donation Programme for Breast Cancer

LEGACY
Start date: March 2014
Phase: N/A
Study type: Observational

Treatment of breast cancer has traditionally been based on the primary tumour's features in the breast. Only recently, when cancer returns at other sites, has there been an attempt to biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be technically difficult, painful and, when possible, only represents a small sample of one of many metastases. Even when one deposit responds to a new treatment, a neighbouring one may continue to grow. There is an urgent need to characterise all deposits, particularly the lethal ones which progress despite all treatments. This study will enable the comprehensive analysis of the metastatic process and the evolution of the breast cancer through the course of its treatment. Patients who have consented during life to donate their tissues for molecular analysis will provide the means for such an analysis. Main aims: - To comprehensively and systematically examine metastatic breast cancer by its detailed exploratory molecular characterization to elucidate the possible inter- and intratumoural heterogeneity between the primary tumour and the majority of metastatic sites. - To map the natural history of the metastatic breast cancer process

NCT ID: NCT02123888 Recruiting - Prostate Cancer Clinical Trials

Simultaneous CBCT Acquisition During Arc Radiotherapy

SCART
Start date: June 2011
Phase: N/A
Study type: Interventional

The cone beam image is a part of the radiotherapy treatment machine and uses lower energy xrays as the head of the radiotherapy machine moves around the patient in a circle. This takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are better at showing the position of the tumour and surrounding soft tissues than the standard xrays that were previously used. Cone Beam Imaging Technology is not new and has been used regularly at The Christie for many years. The standard cone beam scan is taken before the actual radiotherapy treatment or after the treatment has been delivered. Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering radiotherapy that involves the continuous movement of the radiotherapy treatment machine head around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented at The Christie for prostate radiotherapy treatments and work is in progress for implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery makes this simultaneous imaging possible, although there are concerns associated with the impact that this may have on patient dose and image quality. The aim of this research is to assess whether the image quality of cone beam scans taken during treatment are as good as standard cone beam scans taken before or after treatment used to determine the accuracy of patient position and the tumour coverage by radiotherapy.

NCT ID: NCT02116842 Recruiting - Pregnancy Clinical Trials

Minimum Effective Dose (MED) & Epidural Bupivacaine

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose, accidental injection in a blood vessel or slow absorption from the area of injection. The risk of toxicity when performing regional anaesthesia can be reduced significantly by injecting the optimal dose of local anaesthetic at the correct site. To date most of the local anaesthetic dose finding studies for epidural labour analgesia has focused on ED50 ( the dose effective in 50% of patients). The purpose of this research study is to find out the ED95 dose (the dose effective in 95% of patients) of local anaesthetic for epidural analgesia in labour. The dose determined from this research trial will guide the anaesthetists to the optimal starting dose of the local anaesthetics for epidural analgesia in labour. This would lead to decreased chances of toxicity and will improve patient safety. We aim to recruit a total of 100 pregnant patients in early labour (cervical dilatation ≤ 5 cm) requesting epidural analgesia to answer the research question based on the continual reassessment method. Patients will be recruited according to well-defined criteria. They will be fully informed about the study and have the choice of not participating or opting out at any time during the study. It is not going to affect the kind of treatment they receive. The experts in the field with full safety precautions will perform this study at St James' Hospitals, Leeds.

NCT ID: NCT02114411 Recruiting - Stomach Neoplasms Clinical Trials

Gastropanel for Gastric Atrophy and Cancer Risk Assessment

Start date: January 31, 2017
Phase: N/A
Study type: Observational

Background: Atrophic gastritis (AG) is the single most important precursor condition for gastric cancer (GC) known so far. H. pylori infection is the most important causative agent of gastritis, and subsequent AG. The GastroPanel test (Biohit HealthCare, Helsinki, Finland), a blood test evaluating the four biomarkers specific for the gastric mucosa pepsinogen I (P-PGI), pepsinogen II (P-PGII), gastrin-17 (P-G-17) and H. pylori antibody (P-HpAb), is the first non-invasive diagnostic tool providing possibilities for detecting the patients at risk for GC and peptic ulcer as well as malabsorption of vitamin B12, iron, magnesium, calcium and some drugs. A well designed clinical study is warranted to fully assess the performance of GastroPanel examination in detecting the gastric lesions which can lead to GC. The investigators aim to perform a clinical study in an adult population in United Kingdom in order to determine the diagnostic accuracy of the GastroPanel test in evaluating AG and other specific gastric conditions associated with an increased risk for GC. Methods: Two hundred and fifty patients (45 years and older, both genders) will be enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United Kingdom). During the same visit, all patients are subjected to gastroscopy examination, with directed biopsies from the antrum and corpus, following the protocol of the operative link on gastritis assessment (OLGA) classification for chronic gastritis and Sydney Classification. Biopsies are examined at the Pathology laboratory of Homerton University Hospital and interpreted using the OLGA staging system as well as the Sydney system for classification of gastritis. Specific aims: The principal goal of this clinical trial is to establish the performance of the GastroPanel examination in detecting AG and other specific gastric conditions associated with an increased risk for GC. In particular, the investigators will evaluate AG in the antrum, AG in the corpus, AG in both antrum and corpus (=atrophic pangastritis), biopsy-confirmed dysplasia (intestinal metaplasia) of the gastric mucosa. For all these conditions, the investigators will calculate the diagnostic accuracy of the GastroPanel test.

NCT ID: NCT02112357 Recruiting - Clinical trials for Advanced Gastrointestinal Cancers

Feasibility of a Molecular Characterisation Approach to Treatment

FOrMAT
Start date: February 2014
Phase: N/A
Study type: Observational

This study will assess the feasibility of sequencing locally advanced/metastatic gastrointestinal cancers in real-time to enable future treatment stratification by molecular characteristics. Targeted next generation sequencing of a panel of genes will be performed on tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a patient is potentially suitable for a targeted therapy.