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Scleroderma, Diffuse clinical trials

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NCT ID: NCT03644225 Completed - Systemic Sclerosis Clinical Trials

Suction Based Characterization of Healthy and Diseased Skin

Start date: June 11, 2018
Phase: N/A
Study type: Interventional

The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.

NCT ID: NCT03614208 Completed - Systemic Sclerosis Clinical Trials

Individualized Home-based Exercise Program for Patient With Systemic Sclerosis.

ESSE2016
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is an uncommon chronic rheumatic disease with an unknown cause and unpredictable course. The inability, in addition to easy fatigability, starts a vicious circle that leads to a fast deterioration of physical conditions that cause a reduction of aerobic exercise capacity and, consequently, of health-related quality of life (HRQoL). Aerobic exercise has already been shown to be safe and effective in improving exercise capacity and HRQoL of patients with chronic cardiovascular and pulmonary diseases. However, few studies have evaluated the role of specific exercise programs on the muscular impairment in SSc. Nevertheless, the results obtained in preliminary reports are promising, and, for these reasons, the management of muscular impairment in SSc could include an appropriate rehabilitation program besides pharmaceutical and surgical treatments. The primary aim of this study will be to evaluate the effect of an individualized exercise program performed at home on aerobic capacity evaluated by 6 minutes walking test. Secondary aims will be to evaluate: 1- VO2max, measured by cardiopulmonary test; 2- the effect of the same program on the muscular strength of upper and lower limbs; 3- the efficacy of a self-administered stretching program for finger joint motion. Secondary aims will be also 1-to ascertain whether a comprehensive exercise program may affect, besides physical function, HRQoL; 2- and to evaluate the adherence during two periods of three months, one whit and one without supervision and reinforcement by a phone call. All the patients with a diagnosis of SSc, according to the criteria of American College of Rheumatology (ACR), who attended the Rheumatologic outpatient clinic of our institution will be evaluated in order to participate in the rehabilitation program. The pneumological examination and two days of screening and testing will take place at the outpatient's clinic of Respiratory Medicine and Sport of our institution.

NCT ID: NCT03601520 Completed - Clinical trials for Diffusion Limitation of Pulmonary Gas Exchange in Systemic Sclerosis

Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis

DL-SSc
Start date: March 1, 2014
Phase:
Study type: Observational

This study was designed to test the hypothesis that, irrespective of the degree of interstiaI lung disease and/or pulmonary arterial hypertension, the combined measurement of lung diffusing capacity for nitric oxide and carbon monoxide, might be useful to provide a mechanistic interpretation of changes of diffusion subcomponents in systemic sclerosis (SSc).

NCT ID: NCT03575156 Completed - Clinical trials for Systemic Lupus Erythematosus

Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

MICROLUPS
Start date: September 20, 2018
Phase: N/A
Study type: Interventional

Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

NCT ID: NCT03561233 Completed - Systemic Sclerosis Clinical Trials

Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Start date: May 2013
Phase: Phase 1
Study type: Interventional

Proton pump inhibitor (PPI) twice daily dosing regimen—a standard dose therapy for gastroesophageal reflux disease (GERD)—is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.

NCT ID: NCT03558854 Completed - Systemic Sclerosis Clinical Trials

Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients

Start date: August 28, 2018
Phase: Phase 4
Study type: Interventional

Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.

NCT ID: NCT03543956 Completed - Systemic Sclerosis Clinical Trials

Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

VISSEXPOSITION
Start date: June 4, 2018
Phase:
Study type: Observational

Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.

NCT ID: NCT03537105 Completed - Systemic Sclerosis Clinical Trials

Analysis of Cytokine Expression Pattern in Systemic Sclerosis

SCLEROKINE
Start date: July 12, 2018
Phase: N/A
Study type: Interventional

By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.

NCT ID: NCT03531216 Completed - Systemic Sclerosis Clinical Trials

Topical Rosemary Oil Application in Systemic Sclerosis

Start date: November 2, 2015
Phase: N/A
Study type: Interventional

The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.

NCT ID: NCT03508661 Completed - Systemic Sclerosis Clinical Trials

The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial

SPIN-SSLED-F
Start date: April 18, 2018
Phase: N/A
Study type: Interventional

Many people living with a rare disease turn to peer-led support groups to cope with their condition and access educational resources. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease where peer-led support groups play an important role. There are currently approximately 200 SSc support groups in Canada and the US, most of which are led by people with SSc. Many SSc patients, however, cannot access support groups. In other cases, support groups are not sustained due to factors that include the burden on group leaders living with a serious, unpredictable disease and limited group leadership skills of some untrained leaders. Our partners from Scleroderma Canada and the Scleroderma Foundation in the US are committed to improving support group accessibility and effectiveness. These organizations maintain a list of active support groups, but currently do not provide training or other resources to groups or their leaders. To address this gap, our team, including investigators and patients from the Scleroderma Patient-centered Intervention Network (SPIN), developed the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program, which is designed to improve support group leader confidence and self-efficacy, reduce burnout, improve emotional well-being, and improve health-related quality of life. In the planned full-scale randomized controlled trial (RCT) that will follow our feasibility trial, we will evaluate whether the SPIN-SSLED Program is effective in improving SSc support group leaders' self-efficacy for carrying out their leader role (primary) and if it reduces burnout, improves emotional well-being, and improves health-related quality of life (secondary). Thus, the SPIN-SSLED Feasibility Trial answers the following research questions: (1) Is a full-scale SPIN-SSLED RCT feasible? (2) Are adaptations needed to the research design for the planned full-scale RCT? (3) Are there ways to improve the SPIN-SSLED Program for delivery in the planned full-scale RCT based on input of support group leaders who participate in the feasibility trial?