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UVA1 Light for Scleroderma and Similar Conditions

The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study

The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma annulare or other similar skin conditions. This UVA1 dosing schedule has been used successfully in Germany for various skin diseases, such as the above mentioned scleroderma.

NCT00476697 — Scleroderma
Status: Terminated
http://inclinicaltrials.com/scleroderma/NCT00476697/

Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis

T Cell Immunity in Collagen Biosynthesis of Scleroderma

Progressive systemic sclerosis (SSc) is an immune-based disease that causes abnormal connective tissue growth of the skin and internal organs. At this point, there are no effective therapies for treating SSc. Thalidomide is a medication that has been shown to stimulate an immune response that reduces the body's synthesis of collagen, the main component of connective tissue. This study will determine the effectiveness of thalidomide in treating adults with SSc.

NCT00418132 — Scleroderma, Systemic
Status: Terminated
http://inclinicaltrials.com/scleroderma-systemic/NCT00418132/

Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients

The Natural History and Outcome of Patients With Scleroderma at High Risk for or With Early Pulmonary Hypertension

The purpose of this study is to determine the timeline of progression from pre-pulmonary hypertension to diagnosable pulmonary hypertension based on right heart catheterization. Moreover, to determine the timeline for progression from diagnosable pulmonary hypertension to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT symptoms.

NCT00377949 — Pulmonary Hypertension
Status: Completed
http://inclinicaltrials.com/pulmonary-hypertension/NCT00377949/

Placebo Controlled Trial of Bosentan in Scleroderma Patients

Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

NCT00377455 — Pulmonary Hypertension
Status: Terminated
http://inclinicaltrials.com/pulmonary-hypertension/NCT00377455/

Premature Coronary Atherosclerosis in Scleroderma

Premature Coronary Atherosclerosis in Scleroderma: A Case Control Study

The purpose of this trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls.

NCT00372398 — Scleroderma
Status: Completed
http://inclinicaltrials.com/scleroderma/NCT00372398/

Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma

Trial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized Trial

Scleroderma is a systemic disorder categorized as an immunologically mediated disease that causes collagen deposition of skin and visceral organs. The molecular pathogenesis of scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are thought to be important. Once extensive cutaneous or visceral disease occurs, prognosis is significantly shorter than the general population. Although various treatments have been tried, none of them seems to have changed the natural history of scleroderma. Standard dose immunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2 mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effective in treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation with autologous peripheral blood stem cell transplantation (PBSCT) showed some promising data, but the exact efficacy is undetermined (2,3). We now propose, as a phase II randomized study, autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients with systemic scleroderma.

NCT00278525 — SYSTEMIC SCLERODERMA
Status: Completed
http://inclinicaltrials.com/systemic-scleroderma/NCT00278525/

Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death. In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc. The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.

NCT00213460 — Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/systemic-sclerosis/NCT00213460/

Scleroderma: Cyclophosphamide or Transplantation - SCOT

A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)

SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma.

NCT00114530 — Scleroderma, Systemic
Status: Completed
http://inclinicaltrials.com/scleroderma-systemic/NCT00114530/

Scleroderma Registry - Registry

Scleroderma Family Registry and DNA Repository

Scleroderma is likely caused by a combination of factors, including an external trigger (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will conduct genetic analyses for disease-related genes in patients with scleroderma and their family members (parents, brothers, and sisters).

NCT00074568 — Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/systemic-sclerosis/NCT00074568/

Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.

NCT00070590 — Pulmonary Fibrosis
Status: Completed
http://inclinicaltrials.com/pulmonary-fibrosis/NCT00070590/