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NCT ID: NCT01088165 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis

CASTIP
Start date: May 2010
Phase: Phase 4
Study type: Interventional

Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a central role in the pathogenesis of associated comorbidities such as diabetes and cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha which not only plays a central role in the pathogenesis of psoriasis but has also been linked to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have investigated the positive effects of TNF alpha blockers on associated cardiovascular disease in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic agents in patients with moderate to severe chronic plaque psoriasis. The present study aims at determining the effects of adalimumab, a potent and frequently prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation. The effects of adalimumab will be compared with those of fumaric acids, which represent an established traditional systemic treatment option for moderate to severe psoriasis. Study hypothesis: Therapy with adalimumab will lead to an improvement of several parameters that reflect the risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids, hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid intima-media thickness will be secondary outcomes. Aim: If adalimumab and/or fumaric acids will show a significant impact on the above mentioned parameters, these findings would offer a new perspective for the long term management of psoriatic patients and their comorbidities. Study design: Randomized, prospective, controlled, parallel group study Study population: 66 patients

NCT ID: NCT01080495 Recruiting - Clinical trials for Ventricular Function, Left

Evaluation of Radial Strain for Assessment of Left Ventricular Function in Transesophageal Echocardiography

Strain
Start date: February 2010
Phase: Phase 4
Study type: Interventional

Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography. Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC). Radial strain is a new parameter to asses left ventricular function. The investigators want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.

NCT ID: NCT01078194 Recruiting - Morbid Obesity Clinical Trials

Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

Start date: January 2010
Phase: N/A
Study type: Observational

This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.

NCT ID: NCT01078181 Recruiting - Morbid Obesity Clinical Trials

Banded Versus Non-banded Roux-en-Y Gastric Bypass

Start date: November 2009
Phase: N/A
Study type: Interventional

This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.

NCT ID: NCT01066208 Recruiting - Clinical trials for Giant Cell Arteritis

American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis

DCVAS
Start date: January 2011
Phase: N/A
Study type: Observational

Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large group of patients with vasculitis and comparing them to a large group of patients that present in a similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of items to differentiate between vasculitis and 'vasculitis mimics'. We also aim to update the current classification criteria. Classification criteria are used to group patients into different types of vasculitis, once a diagnosis of vasculitis has been made, and are useful for studying patients in clinical trials with similar or identical diseases. The current classification criteria (American college of Rheumatology 1990 criteria) were developed 20 years ago, before the availability of some important diagnostic tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with some of the current disease definitions. Therefore to progress future research in vasculitis, it is important that the classification criteria are updated. We will recruit 260 patients with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the 5 other types of vasculitis), in order to determine the optimal combination of symptoms, signs and investigations that classify each person into the appropriate group.

NCT ID: NCT01065194 Recruiting - Clinical trials for Chronic Stable Heart Failure

Efficacy and Safety of Pulsed Infusions of Levosimendan in Outpatients With Advanced Heart Failure

LevoRep
Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of a pulsed application of Levosimendan versus placebo on the composite end-point functional capacity and quality of life.

NCT ID: NCT01058889 Recruiting - Insulin Resistance Clinical Trials

Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus

Tele-Diab
Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to show if telemonitoring and automated feedback regarding glucose management, physical activity, blood pressure, and body weight improves treatment of patients with insulin dependent Type 2 Diabetes mellitus.

NCT ID: NCT01046448 Recruiting - Clinical trials for Cardiovascular Disease

The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study

4C
Start date: July 2009
Phase: N/A
Study type: Observational

Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities. The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still elusive. In this multicenter, prospective, observational study the prevalence, degree and progression of CV comorbidity in children will be characterized and related to CKD progression. The morphology and function of the heart and vessels will be monitored by sensitive, non-invasive methods and will be compared with aged matched healthy controls. Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors will be monitored prospectively and will be related to CV status. Genotyping might identify predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.

NCT ID: NCT01034969 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

Start date: July 10, 2009
Phase:
Study type: Observational

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

NCT ID: NCT01016002 Recruiting - Clinical trials for Non-curative Resectable Bile Duct Carcinoma

Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Start date: January 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.