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Scleroderma, Systemic clinical trials

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NCT ID: NCT04401943 Active, not recruiting - Systemic Sclerosis Clinical Trials

Online Fatigue Intervention Program for People With Scleroderma

FAME-ISS
Start date: May 13, 2020
Phase: N/A
Study type: Interventional

This research is being done to evaluate if an online fatigue intervention program will decrease fatigue, pain and increase confidence managing fatigue and being able to do daily tasks. This study involves competing a series of questionnaires before and after the intervention , and attending and participating in the online videoconference fatigue program for 1 1/2 hour meetings each week over a 6-week period of time.

NCT ID: NCT04388176 Completed - Systemic Sclerosis Clinical Trials

Cold Challenge With C21 in RP

Start date: January 3, 2020
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis. The purpose of the trial is to achieve a vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R (angiotensin II type 2 receptor) with C21.

NCT ID: NCT04387825 Completed - Systemic Sclerosis Clinical Trials

Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis

Start date: August 13, 2015
Phase: Phase 2
Study type: Interventional

Systemic sclerosis (SS) causes microvascular alteration in the hand and subsequently pain, skin fibrosis, and osteoarticular deformities. These injuries initiate functional decline of the hand and decrease patient quality of life. Local application of adipose-derived stromal vascular fraction (ADSVF) has been proposed as an emerging treatment. There are reports about the good results obtained after ADSVF treatment in this kind of patients. For these reasons , we aimed to evaluate the safety and clinical effect of application of fat micrografts enriched with ADSVF to the hands of patients with SS.

NCT ID: NCT04380831 Recruiting - Clinical trials for Systemic Scleroderma

TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis

Start date: February 24, 2022
Phase: Early Phase 1
Study type: Interventional

This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.

NCT ID: NCT04368403 Active, not recruiting - Systemic Sclerosis Clinical Trials

A Study of KHK4827 in Patients With Systemic Sclerosis

Start date: October 6, 2017
Phase: Phase 1
Study type: Interventional

Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis

NCT ID: NCT04363021 Completed - Preeclampsia Clinical Trials

Is a History of Pre-eclampsia a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?

PREVASCLERO
Start date: July 6, 2020
Phase:
Study type: Observational

Background: Pre-eclampsia, defined by the association of an arterial hypertension and significant proteinuria after 20 weeks of gestation, complicates 1 to 2% of pregnancies in France. Its pathophysiology involves angiogenesis impairment, upregulated maternal systemic inflammatory response, activation of oxidative stress and endothelial dysfunction. In a recent Danish nation-wide cohort study, pre-eclampsia was associated with a 69% increased risk of later developing scleroderma. Type of study: prospective observational case-control study. Primary objective of the study: to determine if a history of pre-eclampsia before systemic sclerosis diagnosis is an independent risk factor for vascular phenotype in sclerodermic women. Secondary objective: to describe all risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months before scleroderma diagnosis.

NCT ID: NCT04356755 Recruiting - Systemic Sclerosis Clinical Trials

Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

ADUSE
Start date: September 22, 2020
Phase: Phase 2
Study type: Interventional

Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.

NCT ID: NCT04356287 Recruiting - Clinical trials for Mesenchymal Stem Cells

Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis

CARE-SSc
Start date: January 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).

NCT ID: NCT04336475 Completed - Systemic Sclerosis Clinical Trials

The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients

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

Systemic sclerosis is a systemic disease which may involve multiple organ systems and cause functional disabilities. Microstomia is one of the most common complications of the disease which may result in difficulties performing oral self-care, complication in professional dental care and even malnutrition in the advanced cases. Since the disease is rare and the studies are limited, there is still not an agreed upon orofacial exercise program to improve the oral aperture of the patients. Therefore, we aimed to investigate the effect of a newly diseased home-based exercise program for improving microstomia in those patient population.

NCT ID: NCT04335396 Recruiting - Diabetes Mellitus Clinical Trials

Screening Patients With Diabetes Mellitus for the Presence of Skin Disorder of Scleredema

Start date: May 28, 2018
Phase:
Study type: Observational

Scleredema is a scleroderma-like skin disorder appearing in 2.5-14% among patients with type 1 or 2 diabetes mellitus. This is a single centre study to screen consecutive patients with diabetes mellitus for the presence of scleredema,and to compare the clinical-laboratory data of patients with and without scleredema. Metabolic and vascular complications of these patients will be focused on.