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Scleroderma, Systemic clinical trials

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NCT ID: NCT02887495 Completed - Scleroderma Clinical Trials

The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)

Start date: July 2014
Phase:
Study type: Observational

The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.

NCT ID: NCT02837549 Completed - Scleroderma Clinical Trials

Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

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

The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.

NCT ID: NCT02835196 Completed - Scleroderma Clinical Trials

Optical Elastography of Systemic Sclerosis Skin

Start date: October 25, 2017
Phase:
Study type: Observational

The goal of this study is to develop a new way to assess skin thickness in patients with scleroderma (systemic sclerosis). The study will test how well a new imaging method called optical coherence elastography (OCE) compares to the current clinical method used to estimate skin thickness, the modified Rodnan Skin Score (mRSS).

NCT ID: NCT02801305 Completed - Clinical trials for Digital Ulcer of Scleroderma

Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers

Start date: June 2016
Phase: Phase 2
Study type: Interventional

Digital ulcers are one of the most prevalent complications of scleroderma (systemic sclerosis). There can be found few surveys on effect of topical agents on healing process of the ulcers. Thus, the aim of this study is to assess and compare the effects of topical diltiazem on SSc digital ulcers versus topical nitroglycerin.

NCT ID: NCT02800993 Completed - Systemic Sclerosis Clinical Trials

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

RAPIDS-2
Start date: October 2003
Phase: Phase 3
Study type: Interventional

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

NCT ID: NCT02789670 Completed - Multiple Sclerosis Clinical Trials

Analysis of the Distribution of Regulatory B Cells in Blood of Multiple Sclerosis Patients

B-MS
Start date: July 2014
Phase:
Study type: Observational

New therapeutic approaches of MS are emerging, targeting different actors of the immune system. Some of them target a specific population of white blood cells: B lymphocytes composed of different subpopulations. The subsets of B cells express different functional properties that control the immune response, but these regulation mechanisms have yet to be clearly described. Some subpopulations could amplify inflammation through IL-6 production for example, whereas some ones contribute to its regulation through the production of IL-10. Using samples collected in a large cohort of individuals with risk of MS and treatment-naive patients in the early onset of the disease, the investigators aim to develop a 2 year follow-up study of the different blood B cells subset distribution and their functional properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach can identify new biomarkers for monitoring of MS patients and lead to better define the indication use of depletive B cell drugs and not to counteract the regulatory action of these cells.

NCT ID: NCT02740569 Completed - Clinical trials for Sleep Apnea, Obstructive

Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

OSASPI
Start date: April 2016
Phase:
Study type: Observational

Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.

NCT ID: NCT02733978 Completed - Scleroderma Clinical Trials

Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis

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

Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes.

NCT ID: NCT02663895 Completed - Systemic Sclerosis Clinical Trials

Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.

NCT ID: NCT02655640 Completed - Clinical trials for Lupus Erythematosus, Systemic

The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis

Start date: October 2015
Phase: N/A
Study type: Observational

This research project has the overall objective to investigate the direction of the associations between illness perceptions, their influencing factors and health-related outcomes. Moreover, the investigators want to look at the direction of the associations between illness perceptions and health related outcomes such as psychological and physical functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc). The investigators want to know whether the outcome variables anxiety, depression, physical (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients' illness perceptions but also the illness perceptions of the General Practitioners (GP) and rheumatologists will be investigated. The researchers want to know if the doctors' perceptions have an impact on the physical and psychological functioning of the patient or vice versa. Much research in the field of illness perceptions is cross-sectional in nature which means that the direction of the relationships between variables is not known.