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NCT ID: NCT01402440 Terminated - Clinical trials for Diffuse Large B-Cell Lymphoma

Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoint for this objective will be occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), assessment of clinical laboratory values, and vital sign measurements.

NCT ID: NCT01401673 Terminated - Cough Clinical Trials

Phase II Open-Label Pilot Study of V3381 in Chronic Cough

Start date: October 2009
Phase: Phase 2
Study type: Interventional

The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation is a hyper-excitability of the sensory nerves as they join the central nervous system, and is believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].

NCT ID: NCT01399593 Terminated - Clinical trials for Antibody Mediated Rejection

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Start date: November 2, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

NCT ID: NCT01398995 Terminated - Type 1 Diabetes Clinical Trials

Managing Insulin Pumps for Exercise (Study 2)

Start date: May 2011
Phase: N/A
Study type: Interventional

People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a background or basal level of insulin is constantly infused under the skin by a special pump, with bolus doses of insulin given to accompany food. Clinical experience suggests that this may be particularly useful for managing diabetes for exercise, but there is limited experimental evidence to support this. The aim of this research , which is divided into three parts, is to investigate the hypothesis that the physiological response to sub-maximal (moderate) exercise of a person with type 1 diabetes treated with CSII, can be made to approximate more closely to the physiological response of a healthy individual by a prior reduction of their basal insulin infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an immediate effect on levels of insulin in the body, and evidence from adults suggests that the level of insulin in the bloodstream at the start of exercise is an important factor in whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin infusion rate some time before exercise may be useful. The aim of this study is to compare the effect of a basal insulin reduction on blood glucose levels between visits when this reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90 minutes before. The null hypothesis to be tested is that there is no difference between these conditions.

NCT ID: NCT01397643 Terminated - Clinical trials for Olecranon Fractures in the Elderly

A Trial of Non-operative Versus Operative Management of Olecranon Fractures in the Elderly

Start date: October 2010
Phase: N/A
Study type: Interventional

Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures within the elderly population with one case series in the literature describing 13 patients. Our trial includes all patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two treatment methods. Patients in the nonoperative group will be place in a sling for two weeks and then allowed to mobilise under supervised physiotherapy as per normal protocol. For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Patients will be evaluated over a one year period following their treatment.

NCT ID: NCT01395264 Terminated - Migraine Clinical Trials

Saccadometry in Primary Headache Syndromes

Start date: August 2011
Phase: N/A
Study type: Observational

Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment. Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients. Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs. This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache. Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.

NCT ID: NCT01392495 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

Start date: June 2011
Phase: Phase 3
Study type: Interventional

This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

NCT ID: NCT01392352 Terminated - Breast Cancer Clinical Trials

HYPAZ: Hypertension Induced by Pazopanib

HYPAZ
Start date: April 2011
Phase: Phase 2
Study type: Interventional

Pazopanib is a new cancer drug that works by limiting the growth of new blood vessels in tumours. About half of patients who take pazopanib develop high blood pressure (hypertension). This side effect can make patients have to reduce or stop their cancer treatment, and can cause other health problems. The aim of this study is to find out exactly how the drug causes high blood pressure.

NCT ID: NCT01390545 Terminated - Clinical trials for Rheumatoid Arthritis

VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

VELVET
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

NCT ID: NCT01389856 Terminated - Clinical trials for Persistent Pulmonary Hypertension of the Newborn

Persistent Pulmonary Hypertension of the Newborn

FUTURE 4
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.