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NCT ID: NCT02193360 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Pilot Study of FFP104 Dose Escalation in PBC Subjects

Start date: May 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the initial safety, tolerability and pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC

NCT ID: NCT02187432 Recruiting - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe

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

EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.

NCT ID: NCT02175810 Recruiting - Obesity Clinical Trials

Impact of Bariatric Surgery on Cardiorespiratory Function

Start date: June 2014
Phase:
Study type: Observational

Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people. Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity. The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.

NCT ID: NCT02175147 Recruiting - Cancer Clinical Trials

Patient-centred Integrated Palliative Care Pathways in Advanced Cancer and Chronic Disease

InSup-C
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

Rationale: Palliative care integration in treatment pathways, palliative care networks and institutional collaborations in health services delivery seems a promising approach reducing fragmentation and discontinuity. Integrated Palliative Care (IPC) approaches in Europe are largely unknown and under-investigated. The investigators aim is to explore experiences of patients with advanced cancer, Chronic Obstructive Pulmonary Disease (COPD) and Chronic Heart Failure (CHF), family and professional caregivers within with IPC. This includes perceived quality of life, quality of care, burden/rewards of care giving, symptoms and collaboration between caregivers in the patient's care network. Objectives: To investigate how patients with advanced cancer, COPD and CHF, their family and professional caregivers within a selection of IPC initiatives in Belgium, Germany, Hungary, The Netherlands and United Kingdom experience care delivery in the last phase of disease. - To investigate what opinions patients and family caregivers have on the (continuity and) quality of care delivered - To investigate how patients rate their symptoms and quality of life - To investigate how family caregivers rate their burden / rewards of care giving - To investigate how the care network of the patient is organised with respect to the type, properties and quality of relationships between patients and family / professional caregivers Study design: Longitudinal multiple embedded case study. Study population: Adult patients with advanced cancer, COPD, and CHF under the care of IPC initiatives in five participating countries, their family and professional caregivers. The investigators aim to enroll up to 288 patients, 288 family caregivers and 192 professional caregivers in total. Study parameters: Experiences with IPC initiatives, quality of care, quality of life, perceived symptoms, perceived collaboration between professional caregivers, burden and rewards of care giving. Methods: Semi-structured interviews, patient diary, Social Network Analysis and the following questionnaires: Palliative care Outcome Scale; Canhelp Lite, Caregiver Reaction Assessment. Patients and family caregivers will be followed over 3 months at 4 consecutive contact points. The diary (containing two questions) will be kept weekly by patients. There will be group or individual interviews with professional caregivers. Analysis: The overall analysis will involve a synthesis of the qualitative and quantitative data. For more information see Detailed Description.

NCT ID: NCT02174965 Recruiting - Hip Osteoarthritis Clinical Trials

Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene

MiniHip
Start date: September 2012
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ECIMA Highly Cross-linked polyethylene.

NCT ID: NCT02174289 Recruiting - Heart Failure Clinical Trials

LV Endocardial Cardiac Resynchronisation Therapy

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

Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart failure with well documented benefits in symptom improvement and reduction of morbidity and mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the recommended indications. Lack of clinical response may be the result of imperfect left ventricular lead placement in the veins around the heart with conventional techniques. Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred heart muscle or may not be at the site of latest electrical depolarisation. In a further 10% of patients, conventional left ventricular lead placement is not possible for other technical reasons. Left ventricular endocardial lead placement may overcome the limitations and allow placement to be guided by echocardiography, electrical mapping and the pattern of heart muscle scarring. We aim to investigate if targeted left ventricular endocardial lead placement improves exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency and biochemical markers of heart strain. Each parameter will be assessed independently and as part of a composite cardiac performance score. Patients with heart failure will be enrolled who require an endocardial left ventricular lead on clinical grounds as either conventional left ventricular lead implantation has technically failed or they have clinically non-responded to CRT.

NCT ID: NCT02169518 Recruiting - Diabetes Mellitus Clinical Trials

Paraoxonase and HDL Qualities in Glycaemia and Inflammation

PON1
Start date: July 5, 2012
Phase:
Study type: Observational

The incidence of coronary heart disease (CHD) is significant in the super-obese and diabetics. Inflammation is believed to play an important part in the development of CHD, and the large collection of abdominal fat in the obese person is a vast source of inflammation. Diabetics have abnormal glucose and cholesterol metabolism which ultimately compromise their bodies' circulatory system and nerve function. Cholesterol plays a vital role in CHD. Low-density lipoprotein (LDL) particles carry cholesterol and deposit it in blood vessel walls which become damaged as a result. When LDL particles undergo changes chemically (called oxidation) or as a result of high circulating blood glucose (called glycation), they become more harmful to the body. High-density lipoprotein (HDL) particles have a protective function in CHD. Not only do they transport cholesterol away from the blood vessels to the liver to be broken down, they have properties against oxidation and inflammation. These properties are related to the activity of an enzyme on HDL called paraoxonase 1(PON1). Super-obese patients are increasingly treated by weight-reducing surgery (bariatric surgery). In this study we examine whether weight loss following bariatric surgery results in reduced inflammatory state, improved HDL function (higher PON1 activity), better control of blood glucose and less nerve damage. We will study PON1 activity, inflammation and glucose control in patients with type 1 diabetes (with and without kidney damage) and type 2 diabetes. We will also study the effects of rapidly rising blood glucose levels on PON1 and glycated LDL in patients undergoing oral glucose tolerance test.

NCT ID: NCT02163109 Recruiting - Critical Illness Clinical Trials

Oxygen Consumption in Critical Illness

Start date: September 2015
Phase:
Study type: Observational

Many serious illnesses are characterised by a lack of oxygen delivery to the body's tissues. This can be due to problems with the circulation, such as when the heart fails to pump blood efficiently or if the blood pressure is very low, or due to changes in the lungs preventing them from transferring oxygen effectively from the air into the blood. Many of the treatments used in critically ill patients are aimed at improving the supply of oxygen-rich blood to the tissues. These include drugs to increase the blood pressure or make the heart pump more forcibly, blood transfusions to increase the amount of oxygen that the blood can carry, and ventilators (breathing machines) to help the lungs introduce more oxygen into the bloodstream. Decisions to use such treatments are based on a number of factors. One of the most important is an assessment of how much oxygen an individual patient is using at a given time. Whilst it is possible to measure average oxygen consumption over a long period of time in healthy individuals, the equipment and techniques needed are simply not practical for routine use in the clinical setting of a critical care unit. Critical care doctors and nurses therefore have to rely on a number of different indicators of the adequacy of the amount of oxygen that is being provided in order to make decisions about how best to treat patients. Unfortunately, all of these have their limitations, are affected by other treatments patients may be receiving, and can be difficult to interpret. Examples include 'mixed venous oxygen saturation' (SvO2), that is the amount of oxygen in the blood coming back to the lungs from the body, ready to have more oxygen added, and blood lactate levels, which give an indication of whether the tissues have enough oxygen to produce the energy they need to function in an efficient manner. Our group has developed a device which can be added easily to the normal equipment used on a critical care ward when a patient is on a ventilator, which can accurately and rapidly measure the amount of oxygen the individual is consuming. This study will provide us with data so the investigators can define a "normal" range of oxygen consumption in these patients, and treatments which alter consumption. In a future study, once the investigators know what the normal range is, they can introduce new techniques to improve oxygen consumption in those patients whose consumption is less than ideal.

NCT ID: NCT02145494 Recruiting - Prostate Cancer Clinical Trials

The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

SPARC
Start date: June 2013
Phase: Phase 2
Study type: Interventional

Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

NCT ID: NCT02136394 Recruiting - Systemic Sclerosis Clinical Trials

The Role of Gastroesophageal Reflux in Scleroderma Pulmonary Fibrosis

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

Scarring of the lungs is common in patients with scleroderma and is one of the main causes of death. Patients with scleroderma very frequently have problems with their gullet (esophagus), the food pipe that leads into the stomach. Normally, a small circular muscle at the base of the esophagus opens to allow food to pass into the stomach and closes to keep the digestive fluids from flowing back up into the gullet. In patients with scleroderma, the muscle may become weak and no longer close properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents into the esophagus. Our hypothesis is that small amounts of GER can move back up into the esophagus and get inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look for certain substances normally only found in the stomach in the "exhaled breath condensate" which is collected by breathing comfortably into a cooled cylinder, allowing the breath to condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar lavage, a more widely studied test in which a small amount of fluid is introduced into a small part of the lungs through a fine tube, and then removed for examination, to evaluate whether the two tests provide similar measurements. We will also evaluate the correlation between these molecules and other tests, including lung function, and markers of lung scarring activity, and tests to look at how the esophagus is working so that we can get a clearer picture of how this affects patients' daily lives. Finally, we will be following up patients over time with lung function to see whether evidence of GER into the lungs is linked with a greater likelihood of worsening of lung scarring in the future.