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NCT ID: NCT02029885 Recruiting - Hypertension Clinical Trials

Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

WAVE_IV
Start date: August 2014
Phase: N/A
Study type: Interventional

To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

NCT ID: NCT02029378 Recruiting - Clinical trials for Gullian Barre Syndrome

Inhibition of Complement Activation (Eculizumab) in Guillain-Barre Syndrome Study

ICA-GBS
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Guillian-Barre Syndrome (GBS) is the most frequent cause of acute neuromuscular weakness in the Western World and can occur at any age. GBS is a rpadily progressive 'inflammatory' disorder of the perihperal nerves often leading to sever paresis of the limbs. Most GBS patients also have sensory disturbances (tingling or dull feeling) and pain. Some patients also have double vision or problems with swallowing. GBS mau also involve the respiratory muscles, leading to insufficient ventilation and admission to an intensive care unit. GBS pateints have a vairable prognosis; 20-30% require mechnical ventilation for a period ranging from weeks to months, 20% are unable to walk after 6 months nad 3-5% dies. Progression of weakness in GBS is usually rapid and reaches its peak within 4 weeks in the majority of patients, but many develop their maximum deficit within 2 weeks. Thereafter, the patients have a variable prognosis. GBS is a treatable disorder. Intravenous immunoglobulin (IVIg) 2g/kg administered in 5 days was shown to be effective when administered within the first two weeks after onset of symptoms, and is considered the treatment of choice by most experts in the field. Although the standard treatment for GBS is a single course of IVIg (2g/kg administered in 5 days), many patients fails to recover abd remain with substantial disability. Patients with GBS and especially those with a poor prognosis potentially may benefit from more powerful abd when possible a more mechanistically rational therapy. Recent experimental evidence suggests that complement activation palys a crucial role in the development of neuromuscular weakness in GBS making complement inhibitors and regulators attracive therapeutic targets. Our hypothesis is that Eculizumab, with its function as a complement inhibitor, will be very effective in preventing progression of weakness in patients with GBS.

NCT ID: NCT02024009 Recruiting - Clinical trials for Pancreatic Neoplasms (Locally Advanced Non-metastatic)

Systemic Therapy and Chemoradiation in Advanced Localised Pancreatic Cancer - 2

SCALOP-2
Start date: March 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the role of increasing radiotherapy dose and addition of nelfinavir to chemoradiotherapy (CRT) in patients with inoperable pancreatic cancer that has not spread beyond the pancreas. Currently in the United Kingdom (UK), either chemotherapy alone or chemotherapy followed by CRT can be used in the management of inoperable pancreatic cancer that has not spread. CRT consists of 25-30 radiotherapy treatments in combination with chemotherapy. Although this treatment is effective in controlling local symptoms and slowing down the pace of cancer, in most cases it is unable to shrink it enough to make it operable. Some of the reasons for this could be the lack of oxygen and lack of blood flow within the tumour making it resistant to the effects of CRT. This study will investigate whether increasing the dose of radiotherapy, or increasing the oxygen and blood supply to the tumour by giving nelfinavir, or a combination of both, can improve outcomes. We also want to know what the additional toxicities from such intensive approaches are. All participants will initially receive 12 weeks of chemotherapy, and those with stable or responding disease will receive further study treatment. The treatment allocation to 1 of the 5 options outlined below will be done at random by computer and neither the doctor nor the patient can choose the treatment option. The process of randomisation ensures that all treatment arms are equally balanced in terms of patient and tumour characteristics, and to reduce the possibility of bias. The study will consist of 2 stages. In the 1st stage we aim to find the right dose of nelfinavir to combine with CRT, and this will require around 27 participants of whom up to 18 will receive nelfinavir together with CRT. In the 2nd stage, we want to find out the benefits of this approach over and above standard treatments and therefore we will recruit the order of 262 participants and allocate 170 to 1 of the 5 following treatment arms: Arm A: Nelfinavir together with CRT Arm B: CRT (without nelfinavir) Arm C: Nelfinavir together with CRT (but using a higher than conventional dose of radiotherapy) Arm D: CRT without nelfinavir (but using a higher than conventional dose of radiotherapy) Arm E: Chemotherapy alone (without radiotherapy) Participants who are ineligible or refuse randomisation will be treated as per local standard but will remain in the study for follow up at 26, 39 and 52 weeks. Their data will contribute to an Overall Survival (OS) analysis.

NCT ID: NCT02016924 Recruiting - HIV Infections Clinical Trials

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Start date: January 16, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV.

NCT ID: NCT02013063 Recruiting - Clinical trials for Malignant Neoplasm of Lung

Single Pulmonary Nodule Investigation

SPUtNIk
Start date: August 2012
Phase: N/A
Study type: Observational

A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis. This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN. The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years. The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018. The study is funded by the NIHR-HTA

NCT ID: NCT02012764 Recruiting - Clinical trials for Rheumatoid Arthritis

The CCP Study: Coordinated Programme to Prevent Arthritis - Can We Identify Arthritis at a Pre-clinical Stage ?

CCP
Start date: January 2007
Phase:
Study type: Observational

This is a 12-month, prospective, observational cohort trial involving Primary Care Trusts (PCTs) wishing to take part in the study and the Early Arthritis Clinic (Anti-CCP sub-clinic) at Chapel Allerton Hospital. The approximate duration of subject participation will be 12 months and the approximate total duration of the study will be 10 years. Patients who have not developed inflammatory arthritis within the 12 month period will have the opportunity to continue follow up within the clinic on an annual basis with additional visits as clinically indicated until the development of IA.

NCT ID: NCT02010892 Recruiting - Clinical trials for Thoracic Aortic Aneurysm

Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study

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

This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described. Aims We aim to answer the following questions: 1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)? 2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death? 3. How does QoL change from pre- to post intervention? 4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined? 5. What is the most cost-effective strategy in: 1. Patients eligible for either ESG or OSR? 2. Patients eligible for either ESG or best medical therapy (BMT)? 3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)? 6. What further research is required? What would be the most important research to pursue?

NCT ID: NCT02006134 Recruiting - Clinical trials for Microscopic Polyangiitis

Pediatric Vasculitis Initiative

PedVas
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most knowledge about them comes from adult patients. Severe disease requires aggressive life-saving treatments with steroids and some cancer drugs which can themselves cause damage, and increase risks of cancer and severe infections. Conversely, milder disease can be treated with less toxic drugs. Different classification and "scoring tools" are used to define the types and severity of vasculitis and to measure damage caused by disease or drugs. These in turn help direct how aggressively to treat a patient and to measure outcome. None of these tools however have been assessed in children and the best balance of disease and treatment risks against outcome for children is not known. Although causes of these diseases in children and adults are probably the same, the effects of the disease and the response (good and bad) to drugs will differ in growing children. Because specialists may see only one new child with vasculitis each year, obtaining enough information to learn about childhood vasculitis requires cooperation. We will use an international web-based registry to which doctors from 50 or more centers can contribute patient data. We will determine the features which help better classify and diagnose children compared to adults. Through the web we will collect and analyze information on patients similarly classified and "scored" so that most successful treatments can be identified. Children with vasculitis are less likely to have diseases associated with aging, alcohol and smoking etc., and therefore may be a better group in whom to study the underlying biology of vasculitis. We will use this opportunity and collect spit, blood and tissue from registry patients for laboratory study with an aim to find biomarkers to better classify, define and direct optimal treatment and outcomes.

NCT ID: NCT02001493 Recruiting - Clinical trials for Renal Cell Carcinoma

Metabolomic Profiling in Renal Cell Carcinoma

Start date: January 2014
Phase: N/A
Study type: Observational

Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy. Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that are useful surrogates for clinical response and also to identify patients early on who will benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in patients and also in reducing cost implications of this expensive group of drugs. The investigators wish to explore the variability of baseline metabolomic profile in the blood and urine of patients with mRCC and characterise the inter-subject and intra-subject variability. The study of the baseline levels has not been performed in this cohort previously. This is extremely important in interpreting the emerging data of changes in the levels of the various biomarkers from various trials. This will in turn help in the development of future targeted therapies, especially Phase I/II studies where an early demonstration of target modulation is vital. This study will also help to identify the number of patients required for appropriate statistical evaluation in pharmacodynamic studies to assess biological activity, optimisation of dosing, and investigation of potential mechanisms of resistance. Study of the urinary and blood metabolomic profile in conjunction will give us an insight into the potential use of urine as a diagnostic and prognostic tool. OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after nephrectomy or antiangiogenic treatment during 2 months

NCT ID: NCT01999998 Recruiting - Clinical trials for Improve the Radiotherapy Planning Process

FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3

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

Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent cure rates. However, a significant proportion of these patients develop cancers and heart diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible. In order to safely minimise the volume treated with radiotherapy it is necessary to accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning' CT scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent of the lymphoma, but is taken in a different position to the radiotherapy treatment position. This aim of this study is to explore whether a PETCT scan taken prior to chemotherapy in the radiotherapy treatment position, in conjunction with advanced software to combine this scan with the subsequent radiotherapy planning CT, can be used to more accurately identify the lymphoma target. The study aims to recruit up to 20 patients with early stage Hodgkin lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will be followed at the same session by a PETCT in the radiotherapy treatment position appropriate radiotherapy immobilisation devices. Participation in the study will not affect treatment decisions or the radiotherapy planning process. The PETCT in the radiotherapy planning position will be made available to the treating clinicians. The process of planning radiotherapy will not be systematically altered by the study. The study is aimed at determining how to improve the radiotherapy planning process in the future, in the hope of a reducing in the long term side effects of treatment whilst retaining high cure rates.