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NCT ID: NCT02062684 Completed - IgA Nephropathy Clinical Trials

BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

Start date: June 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

NCT ID: NCT02062619 Completed - Stroke Clinical Trials

Brain Mechanisms Underlying Reading Improvement in Central Alexia

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

Central alexia is a common reading disorder caused by stroke. Patients with central alexia (CA) are slow to read and make frequent errors, and have additional problems with their spoken language. This study has 3 aims: 1. Investigating the neural networks that support reading in patients with CA Despite being a relatively common syndrome, there have been no functional brain imaging studies of CA. This project will use magnetic resonance imaging (MRI) and magnetoencephalography (MEG) to understand which brain regions are damaged and whether preserved parts of the reading network can be encouraged by therapy to support reading recovery. 2. Testing a new treatment for CA The research team has developed training software called 'iReadMore', which uses a crossmodal approach (written words paired with spoken words) to train reading. This therapy has been shown to be effective in patients with a similar form of reading disorder called pure alexia. The iReadMore software will be adapted to address the reading deficit in CA, and the research will test whether it significantly improves reading ability. 3. Using brain stimulation to enhance behavioural training Transcranial direct current stimulation (tDCS) is a brain stimulation technique that has been shown to improve language performance in healthy controls and stroke patients. This study will test whether tDCS (delivered simultaneously with the 'iReadMore' therapy) significantly enhances reading rehabilitation. Patients will be split into two groups: one will receive a 4 week block of training plus real tDCS first, followed by a 4 week block of training plus sham tDCS; the other group will receive the two therapy blocks in the opposite order. Both groups will ultimately receive the same amount of behavioural therapy and tDCS stimulation. Comparing the reading improvement over the real and sham tDCS blocks will demonstrate whether tDCS enhances the behavioural improvements in reading ability. Hypothesis: iReadMore reading therapy will significantly improve single word reading speed in patients with central alexia. tDCS brain stimulation will significantly enhance the effect of iReadMore therapy, compared to sham stimulation.

NCT ID: NCT02062593 Completed - Stable Angina Clinical Trials

Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

ORBITA
Start date: December 2013
Phase: N/A
Study type: Interventional

In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

NCT ID: NCT02062463 Completed - Asthma Clinical Trials

Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma

ELIOT
Start date: May 28, 2014
Phase: Phase 3
Study type: Interventional

This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.

NCT ID: NCT02062346 Completed - Vasculitis Clinical Trials

Endothelin Antagonism in ANCA Vasculitis

Start date: August 2016
Phase: N/A
Study type: Interventional

Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are not clear and is not adequately treated with current drugs. It is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk. Endothelin is a chemical produced by blood vessels that contributes to the development of hypertension and cardiovascular disease Higher than normal levels of endothelin are seen in patients with vasculitis but how this contributes to cardiovascular disease in patients with vasculitis is not clear. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular disease in patients with vasculitis. The purpose of the study is to ascertain if endothelin receptor antagonists improve blood vessel function in patients with vasculitis.

NCT ID: NCT02061540 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis

CAMEO
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.

NCT ID: NCT02061527 Completed - Breast Cancer Clinical Trials

Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

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

To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.

NCT ID: NCT02061345 Completed - Prostate Cancer Clinical Trials

PET Imaging in MCI Following ADT for PCa

Start date: April 2014
Phase:
Study type: Observational

Mild cognitive impairment (MCI) with ageing is thought in part to be related to reduced serum sex hormones which is well-recognized, especially in females, but poorly understood. International studies assessing hormone replacement therapy (HRT) to prevent/reduce MCI are ongoing. MCI leads to morbidity, reduced quality of life and substantial healthcare costs. The commonest therapeutically induced reduction in sex hormone level in men is treatment of prostate cancer (PCa). PCa is androgen dependent and androgen deprivation therapy (ADT) suppressing testosterone to castrate levels is key therapy for advanced disease. About one million men worldwide have received ADT for PCa, mostly using luteinising hormone releasing hormone agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps 4% of Caucasians may be castrated. MCI as a side effect of castration in men remains poorly researched. This study aims to demonstrate that pathological changes occur in the brains of a significant proportion of prostate cancer patients subjected to ADT that correlate with MCI symptoms. Highlighting the pathological changes of MCI should improve understanding and interventions for slowing/preventing MCI in PCa survivors. Brain scans employing positron emission tomography (PET) imaging technique will be used to detect the presence of pathological changes in the brain that relate to ADT induced MCI. MCI will be assessed by neuropsychological assessments (standard paper-based questionnaires and online) and its neural basis will be investigated using magnetic resonance imaging (MRI).

NCT ID: NCT02061241 Completed - Heart Failure Clinical Trials

A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation Therapy

IDEAL-CRT
Start date: April 2014
Phase: N/A
Study type: Observational

Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT. Targeting the position of the left ventricular (LV) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT. Several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP occurs. Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information. The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR. It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed. This study will also be able to contribute towards several important secondary questions. In particular the investigators will study the possibility of using non-invasive cardiac output monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure monitor wire. The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.

NCT ID: NCT02060799 Completed - Dyspnea Clinical Trials

European Dyspnoea Survey in the EMergency Departments

EuroDEM
Start date: February 2014
Phase: N/A
Study type: Observational [Patient Registry]

Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms patients can experience; and it is one of the main complaints in the patients presenting to the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac, pulmonary or metabolic etiologies or a combination of them, since several diseases can cause dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary disease (COPD). Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure (HF) is one of the most important causes of morbidity and mortality in the industrialized world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general European population. The incidence increases rapidly with age, and in Europe. Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to hospital have been adequately described, in Europe and in the United States. The Euro Heart Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively. This same sensation of breathlessness is what also drives patients with asthma and chronic obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD) exacerbation accounts for approximately 1.5 million ED visits in the United States per year. It is the third most common cause of hospitalization, with an estimated 726 000 hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences between guideline recommendations and actual management of COPD exacerbation, either in the ED or during hospitalization. The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low sensitivity of the clinical signs associated with the aging of the population and the variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED at the European level. Diagnosis, prevalence and treatment of the patients may vary among European countries.