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Scleroderma, Diffuse clinical trials

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NCT ID: NCT02212249 Completed - Systemic Sclerosis Clinical Trials

Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

Sclerocadh1
Start date: May 2014
Phase: N/A
Study type: Interventional

Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.

NCT ID: NCT02161406 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

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

The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.

NCT ID: NCT02105818 Completed - Systemic Sclerosis Clinical Trials

Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis

SWAMECO
Start date: March 2014
Phase: N/A
Study type: Observational

The purpose of this study is the validation of a newly developed self-report questionnaire which aims at determining the prevalence, location and intensity of SWAllowing difficulties with drug intake, and describing the impact on MEdication regimen focusing on COping strategies (SWAMECO).

NCT ID: NCT02062125 Completed - Scleroderma Clinical Trials

Calcinosis in a Single-Center Scleroderma Population

SSc-calcinosis
Start date: October 31, 2012
Phase:
Study type: Observational [Patient Registry]

This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis 2) to identify common complications associated with scleroderma-related calcinosis. .

NCT ID: NCT02047708 Completed - Clinical trials for Chronic Kidney Disease

Zibotentan Better Renal Scleroderma Outcome Study

ZEBRA
Start date: October 2014
Phase: Phase 2
Study type: Interventional

Many patients with scleroderma have damage to their kidneys caused by the disease. There is limited evidence for treatments to prevent this damage or stop it progressing. Blocking a substance in the blood called endothelin has helped treat some aspects of scleroderma. The purpose of this study is to see how effective a new endothelin blocker called Zibotentan is in treating patients who have scleroderma and have gone on to develop reduced kidney function as a complication. It will be given in addition to the accepted treatments used for scleroderma. There will be three parts to this study each for a different group of patients: - ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma - ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by scleroderma (scleroderma renal crisis) who do not require dialysis - ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis

NCT ID: NCT02006420 Completed - Scleroderma Clinical Trials

Scleroderma ARFI Imaging of the Skin

ARFI
Start date: December 2013
Phase:
Study type: Observational

Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening. Currently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy. The researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI). The investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin. This type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.

NCT ID: NCT01971294 Completed - Systemic Sclerosis Clinical Trials

Lower Urinary Tract Symptoms in Systemic Sclerosis

Start date: October 2013
Phase:
Study type: Observational

Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. In another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one (lcSSc). But prevalence or incidence is unknown. Urinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death. Thus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death. This study will also give basement to build an interventional study directed toward LUTS treatment in this population. In this prospective cohort we would like to: - Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited forms of systemic sclerosis. - Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS among patients suffering from systemic sclerosis. - Evaluate the impact of LUTS symptoms on Quality of life. - Compare the discrimination ability of Cochin-hand score and HAQ score to predict incontinence in this population. - Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.

NCT ID: NCT01959815 Completed - Clinical trials for Pulmonary Arterial Hypertension

Novel Screening Strategies for Scleroderma PAH

Start date: September 26, 2013
Phase:
Study type: Observational

Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.

NCT ID: NCT01933334 Completed - Systemic Sclerosis Clinical Trials

Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Start date: September 2013
Phase: Phase 2
Study type: Interventional

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD).

NCT ID: NCT01931644 Completed - Breast Cancer Clinical Trials

At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions

Start date: July 2013
Phase:
Study type: Observational

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