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NCT ID: NCT01800409 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Abdominal Functional Electrical Stimulation Training and Its Effect on Mechanical Insufflation-Exsufflation

Start date: February 2013
Phase: N/A
Study type: Interventional

Compromised respiratory function as a result of tetraplegia is a leading cause of rehospitalisation for the tetraplegic patient group. Electrical stimulation of the abdominal muscles has previously been used to improve the respiratory function of tetraplegic patients in the chronic stage of injury. In this study the investigators aim to evaluate the optimum protocol for the use of electrical stimulation of the abdominal muscles to improve the respiratory function of the tetraplegic population. The investigators also aim to investigate whether abdominal functional electrical stimulation combined with mechanical insufflation-exsufflation can be used to help further improve the respiratory function of the tetraplegic population.

NCT ID: NCT01795768 Recruiting - Breast Cancer Clinical Trials

Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours

FGFR
Start date: September 2012
Phase: Phase 2
Study type: Interventional

To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy

NCT ID: NCT01792934 Recruiting - Clinical trials for Multi-organ Metastatic Colorectal Cancer

Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases

ORCHESTRA
Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare overall survival rates of colorectal cancer patients with multi-organ metastases with an indication for first line systemic treatment randomized for treatment with combination chemotherapy or treatment with combination chemotherapy and additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and SBRT, depending on best clinical judgement according to a standardized treatment algorithm. Our hypothesis is that maximal tumor debulking in addition to systemic treatment with chemotherapy and biologicals will provide an improvement in progression free and overall survival in this patient group.

NCT ID: NCT01792726 Recruiting - Early Breast Cancer Clinical Trials

A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.

TARGIT-B
Start date: June 2013
Phase: N/A
Study type: Interventional

TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.

NCT ID: NCT01792349 Recruiting - Stroke Clinical Trials

Increasing Physical Activity in Stroke Survivors Using STARFISH

Start date: February 2013
Phase: N/A
Study type: Interventional

There is good evidence of the effectiveness of regular physical activity in the primary and secondary prevention of stroke. STARFISH is a smartphone-based application designed as a behavioural change intervention to encourage the user to become more physically active. The study will investigate if using STARFISH for 6 weeks can increase physical activity in people after stroke. Subjects will be randomised to the STARFISH intervention or a control group. Control subjects will not have access to their daily activity count.

NCT ID: NCT01781260 Recruiting - Cardiac Output Clinical Trials

Effect of Prone Position on Liver Blood Flow and Function

PLiF
Start date: May 2014
Phase: N/A
Study type: Observational

Recent occurrence of significant post-operative liver impairment at Nottingham University Hospitals NHS Trust has prompted investigation into whether interaction between general anaesthesia and prone positioning (lying face down) for surgery can influence liver function. Historical research has shown that the heart does not function as efficiently when an anaesthetised patient is placed in the prone position for surgery. The techniques used for anaesthetising and monitoring these patients have changed remarkably, since these studies were first performed. It is important to know accurately how the heart functions to enable better understanding of the changes in blood flow to the liver when in the prone position. Studies looking at blood flow to the liver when lying face down have been done before but are mainly reporting patients on the intensive care unit. These intensive care patients are different to those in theatre undergoing routine surgery. The intensive care patients are usually received in different types of drugs and monitored with several different types of monitor at the time. Perhaps most importantly is that they are placed face down on a soft air cushioned mattress and pillows rather than the rigid support used for surgical patients. This study will look at whether the function of the liver changes when a patient is anaesthetised and is then rolled onto their front. The function of the liver will be measured by looking how it clears a specific drug from the blood. Also this study will look at how accurate a particular type of heart monitor is when an anaesthetised patient is placed onto their front.

NCT ID: NCT01780597 Recruiting - Heart Failure Clinical Trials

Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.

Start date: February 2013
Phase:
Study type: Observational

The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment. Ultimately this may lead to an increase the number of hearts available for transplantation.

NCT ID: NCT01774279 Recruiting - Clinical trials for Anaplastic Thyroid Cancer

interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT)

iNATT
Start date: June 2013
Phase:
Study type: Observational [Patient Registry]

Anaplastic thyroid cancer has historically proven very difficult to research due to a combination of its rarity and the associated short survival period for those affected. In 2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be the anaplastic subtype 1,2. For these patients average life expectancy is in the range of 2-6 months with only a very small number surviving for more than one year. It is a highly aggressive form of cancer that is refractory to current treatment options. By collecting tissue and blood samples along with clinical data across the UK we will be able to accumulate numerically significant numbers of samples and data points which will facilitate research opportunities. Researchers will be encouraged to apply for access to the collected samples in order to try and establish the causal mechanisms for disease development, potential therapeutic targets and to relate clinical course and outcome with specific molecular defects. Due to the rarity it is not feasible for a single cancer centre or cancer network to accumulate sufficient samples for research in a meaningful timeframe hence the need for national collaboration in order to try and offer patients with this disease hope in the future. All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is expected to run for at least 15 years and all thyroid cancer clinicians will be encouraged to participate. Patients will be asked to donate surplus thyroid cancer tissue following routine biopsy procedures along with an optional blood sample. 2. Objectives Primary Objectives The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities. There is no direct research question that the project itself addresses at this stage. The research proposals that subsequently arise as a result of this project will be generated by accredited research parties from the UK and potentially internationally. These research proposals will be submitted to the interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project (iNATT) Steering Committee for assessment. As the volume of material collected per patient is expected to be of small volume, by virtue of the specimen comprising core biopsy or fine needle aspirate material, research proposals will need to be prioritised according to the potential benefits the proposed research offers. Priority will be given to projects that may lead to the identification of potential therapeutic targets. Each research proposal will require their own ethical approval and research and development assessments before commencing. The steering committee will be multidisciplinary and will include nationally respected researchers and thyroid cancer clinicians. Scientific Justification The long term objective is to try and address the current lack of understanding about the aetiology and progression of this disease and ultimately to develop new therapeutic interventions that may slow the rate of disease progression, improve quality of life and prolong what is currently a very short survival. Due to the short prognosis following diagnosis it is notoriously difficult to run interventional therapeutic clinical trials in this patient population. Patients usually present with locally advanced and metastatic disease and as a consequence are often of poor performance status making clinical trial participation very problematic. If potential therapeutic targets could be identified in vivo it would potentially open up new therapeutic avenues whilst sparing some patients with the 'wrong' molecular profile futile treatment. This is a unique project within the setting of anaplastic thyroid cancer research.

NCT ID: NCT01770535 Recruiting - Ovarian Cancer Clinical Trials

Oxford Ovarian Cancer Predict Chemotherapy Response 01

OXO-PCR-01
Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.

NCT ID: NCT01761097 Recruiting - Colorectal Cancer Clinical Trials

Endocuff Adenoma Detection Rate Pilot Study

Start date: January 2013
Phase: N/A
Study type: Interventional

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope. The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.