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NCT ID: NCT02275221 Recruiting - Hepatitis C Clinical Trials

Immune Response in Patients With Hepatitis B and C Infection

Start date: August 2013
Phase:
Study type: Observational

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, the investigators hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression.

NCT ID: NCT02275195 Recruiting - Hepatitis Clinical Trials

Immune Cell Dysfunction in Severe Alcoholic Hepatitis

Start date: November 2013
Phase:
Study type: Observational

Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.

NCT ID: NCT02273271 Recruiting - Clinical trials for Non-small Cell Lung Carcinoma

Evaluation of FLT-PET and DWI-MRI in Patients With NSCLC Treated With a Platinum-based Doublet as Preoperative Chemo

EVIDENCE
Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to qualify, independently, tumor cell proliferation by 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological quantification (% of viable tumor cells) of the primary tumor after pre-operative chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).

NCT ID: NCT02272478 Recruiting - Clinical trials for Myelodysplastic Syndrome

Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations

AML18
Start date: October 30, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The AML18 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years considered fit for an intensive chemotherapeutic approach, but younger patients who may not be considered suitable for the concurrent NCRI AML Trial for younger patients may also enter. Patients for whom intensive chemotherapy is not thought suitable may enter the concurrent NCRI trial of less intensive therapy (LI1). Approximately 1600 patients will be recruited. At entry, a randomisation will compare a standard chemotherapy schedule DA (Daunorubicin/Ara-C) combined with 1 dose of Mylotarg (gemtuzumab ozogamicin, or GO) in course 1 against CPX-351. Patients who have known adverse risk cytogenetics (using Grimwade 2010 classification favourable/intermediate/adverse) at diagnosis may enter a Phase 2 evaluation of the combination of Vosaroxin plus Decitabine. Patients who achieve complete remission (CR) and who are MRD negative by flow cytometry after course one of DA will receive one further course of DA, with a randomisation to receive, either a course of DA or intermediate dose Cytarabine (IDAC) as a third course. Patients who are MRD negative by flow cytometry after course one of CPX-351 will receive up to 2 further course of CPX. Patients who fail to achieve a CR after course 1 of DA or who are MRD positive by flow cytometry or for whom MRD information is not available, are eligible to be randomised to compare DA with DA plus Cladribine (DAC) or FLAG-Ida for up to two courses of therapy. Patients who fail to achieve a CR after course 1 of CPX-351 or who are MRD positive by flow cytometry or for whom MRD information is not available are eligible to be randomised between a second course of standard dose CPX versus a repeat of the course 1 schedule. Patients receiving Vosaroxin and Decitabine are excluded from these post course 1 randomisations . Following the outcome of course 1, patients who received DA chemotherapy on course 1 will be randomised to receive further chemotherapy with the 2nd generation FLT3 inhibitor AC220. Patients randomised to AC220 will be allocated a maximum of 3 courses (short AC220) or 3 courses plus maintenance for 1 year (long AC220). Patients receiving Vosaroxin and Decitabine are excluded from this randomisation. Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable HLA matched donor is available.

NCT ID: NCT02270190 Recruiting - Clinical trials for Pelvic Floor Disorders

PTNS as a Treatment for Tenesmus

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

The main research question is to see if Percutaneous Tibial Nerve Stimulation (PTNS) can improve the symptom of tenesmus in patients with pelvic floor disorders. This includes those who have rectal cancer in situ or who are post-rectal cancer treatment and have Anterior Resection Syndrome. The secondary research questions are to see if other pelvic floor symptoms and quality of life improves for this patient group and if levels of anxiety and depression improve for these patients.

NCT ID: NCT02267590 Recruiting - Clinical trials for Mantle Cell Lymphoma

Tissue Collection for Biomarkers Determining Resistance to Ibrutinib

CLARITY
Start date: October 2014
Phase: N/A
Study type: Observational

Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.

NCT ID: NCT02266992 Recruiting - Clinical trials for Acquired Immune Deficiency Syndrome Virus

Exploring Novel Mechanisms of Vaccine Failure LAIV Pilot Study

LAIV
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Influenza ('flu) can cause severe infections, especially in people with weakened immune systems such as those with HIV. For this reason, yearly vaccination is recommended with the standard 'inactivated' influenza vaccine to try and prevent infections in these populations. It is also recommended in all health care workers, to help prevent the spread of influenza within healthcare settings. However, having HIV infection may mean vaccines work less well in some people and the investigators do not completely understand why. An alternative to the standard 'inactivated' annual influenza vaccine is the 'live attenuated influenza vaccine' (LAIV), which means it consists of weakened versions of the influenza virus. Unlike the standard vaccine, which is given by injection, LAIV is a spray that is given into each nostril. It is now given to children in the UK in preference to the standard vaccine as it results in greater protection from influenza. In some other countries, like the USA, adults are also given LAIV, where it seems to work just as well as the standard vaccine. A few studies in the past have shown that LAIV is safe and effective in HIVinfected children and adults. The investigators want to give LAIV to HIVinfected and HIV negative individuals, to try to find out new information about how HIV infection may change the way in which people respond to vaccines. The investigators will do this by comparing both the early genetic response to the vaccines and later responses from cells specifically targeted to fight influenza ('Tcells'), in these groups. In the long term, the investigators hope that this will lead to designing new ways of improving the response to vaccines in HIVinfected people. As LAIV is given into each nostril, rather than an injection, the investigators also want to see if LAIV results in Tcells in the lung that are specifically targeted to fight influenza

NCT ID: NCT02266316 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Use of an Air Warming Mask for Exercise in Patients With COPD V1.0

Start date: March 2012
Phase: N/A
Study type: Interventional

The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not one single disease but an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004) that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK. COPD results from damaged airways in the lungs, causing them to become narrower and making it harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of air that can be expelled in the first second of breathing out (FEV1) in litres per second. COPD is a progressive disease and the condition can have a serious impact on the quality of life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and increased breathlessness. This is a randomised crossover controlled trial of participants with COPD. It compares the effectiveness of an air-warming face mask which covers the mouth compared with no face covering, in increasing participants exercise capacity and quality of life in cold weather. The mask warms air at the mouth by drawing on air warmed beneath the participants clothing, through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air is expired through the nose. 24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate days. Two tests will be in an environmentally controlled chamber performed at 5°C with participants wearing either the mask or no face covering. The third test will be performed at ambient temperature outside the chamber. The order will be determined by random allocation. Participants will undergo the Treadmill 6 Minute Walk Test; various measurements will be taken, all of which will be non-invasive.

NCT ID: NCT02265770 Recruiting - Clinical trials for Childhood Ependymoma

An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma

SIOP-EP-II
Start date: June 2, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to improve the investigators understanding of the underlying biology thereby informing future treatment. The program will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations. Patients will be stratified into different treatment subgroups according to their age, the tumour location and the outcome of the initial surgery. Each subgroup will be studied in a specific randomised study to evaluate the proposed therapeutic strategies. Stratum 1: The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression free survival in patients who are > 12 months and < 22 years at diagnosis, with completely removed intra cranial Ependymoma. Stratum 2: This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving to all patients the benefit of VEC chemotherapy whilst randomising half of patients to receive additional HD-MTX. Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the residual tumour will be delivered immediately after the end of the cRT. Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of postoperative dose intense chemotherapy administered alone or in combination with valproate in children <12 months of age or those not eligible to receive radiotherapy .

NCT ID: NCT02264743 Recruiting - Insulin Resistance Clinical Trials

Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy

OPTIMISE
Start date: November 2013
Phase: Phase 4
Study type: Interventional

Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will be avoided.