There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery (maximum of 14 weeks from surgery to start of radiotherapy).
The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus. About 10−30% of women carry GBS in the vagina or rectum. During labour this infection can be passed to the neonate. This can lead to the baby developing a serious infection. However, research has shown that if antibiotic treatment is given to GBS carrying women during labour most of these infections can be avoided. A new bedside test known as PCR has been shown to produce a GBS diagnostic result in less than an hour. In clinical trials conducted in the US and France this method has been shown to be more accurate than either prenatal vaginal swabs or risk factor assessment. For this reason, PCR may be helpful in screening and treating GBS positive women in the UK. In this study the investigators will compare each of the following three methods of diagnosis to a gold standard. - Prenatal vaginal culture swab (at 35 to 37 weeks gestation)− The US approach. - Risk factor assessment (at the time of admission for labour)− The UK approach - The new PCR test (at the time of your labour admission) The investigators will compare the accuracy of each of these methods with the most accurate method for determining the GBS status during labour. This 'most accurate' method is a highly sensitive swab test which unfortunately takes several days to produce a result. For this reason this test will not tell the investigators whether prophylactic antibiotics may be useful during labour (Receiving them after birth is ineffective). If PCR is shown to be a more accurate method of identifying GBS positive women this may help to reduce the number of infections in new born infants and as a result may help to save lives.
The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lapatinib ditosylate is more effective than a placebo in killing tumor cells. PURPOSE: This randomized phase II/III trial is studying how well lapatinib ditosylate works compared to a placebo in treating patients with stage IV bladder cancer.
RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required. PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.
This Phase 3 study is designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who have reached therapeutic goals with enzyme replacement therapy (ERT).
This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy, safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin (Eloxatin®), and fluoropyrimidine. After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a major healthcare problem with huge human and economic costs. It affects 3 million people, results in 1.4 million consultations, causes 30,000 deaths, and costs £800M per year in the UK. Considerable research expenditure is devoted to finding new and expensive interventions. However pulmonary rehabilitation (PR) is an available therapeutic option with good evidence of benefit for patients in terms of quality of life and daily functioning. The primary objective of the study is to evaluate the effectiveness and cost effectiveness of the addition of a maintenance programme following pulmonary rehabilitation in patients with COPD when compared to standard care. The secondary objective is to identify baseline characteristics that will predict improvement in pulmonary rehabilitation programmes and adherence to maintenance strategies. By measuring a series of demographic, clinical, physiological, psychological and biochemical parameters the researchers hope to be able to predict those patients who are likely to receive the greatest benefit from pulmonary rehabilitation. An additional objective will be to prepare a detailed maintenance programme manual. This will be available to other centres providing pulmonary rehabilitation at the conclusion of the study
Obstructive airways disease is a very common condition. This condition includes patients with asthma, chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis. Some patients with obstructive airways disease have problems with long term breathlessness, wheeze and cough with or without sputum production. Currently the researchers give treatments - usually inhalers - which are designed to open the airways and reduce the breathlessness and wheeze. Despite these available treatments many patients still have continuing symptoms. Anecdotal clinical evidence suggested that a herbal remedy (called AKL1) has beneficial effects in respiratory conditions, with patients diagnosed as having both asthma and COPD reporting reduced symptoms including breathlessness and cough and reduced frequency of attacks.The purpose of this study is to confirm whether AKL1 does indeed have a meaningful benefit to patients with obstructive airways disease. The researchers will mainly be measuring any effect of AKL by assessing any change in trial subjects' coughs, using a questionnaire, but the researchers will also looking at breathing tests, walking tests, blood and sputum tests.
The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate. Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice. Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative. The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide. The statistical analysis will be performed by Agendia and an independent research institute or hospital. Study Design Extension Study: This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power). Reporting of the Results: Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results. Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.