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Scleroderma, Diffuse clinical trials

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NCT ID: NCT04684225 Completed - Rehabilitation Clinical Trials

Telerehabilitation on Hand-Affected Scleroderma

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

NCT ID: NCT04675502 Completed - Systemic Sclerosis Clinical Trials

Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis

Start date: June 10, 2018
Phase: N/A
Study type: Interventional

Scleroderma, also called systemic sclerosis (SSc); It is a heterogeneous multiorgan disease of unknown etiology characterized by vasculopathy, autoimmunity and fibrous tissue. It is stated in studies that cardiac and pulmonary systems are affected in patients with SSc and these effects affect the aerobic capacity, physical functions and quality of life of patients negatively by disrupting their pulmonary and musculoskeletal functions. However, considering the treatment approaches in scleroderma patients, the number of studies evaluating the effectiveness of pulmonary rehabilitation and exercises is limited. Therefore, the purpose of our study; Comparison of the effects of a supervised exercise program and a home exercise program in patients with Systemic Sclerosis.

NCT ID: NCT04647890 Completed - Clinical trials for Scleroderma, Systemic

Effects of FT011 in Systemic Sclerosis

Start date: July 19, 2021
Phase: Phase 2
Study type: Interventional

FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).

NCT ID: NCT04588714 Completed - Scleroderma Clinical Trials

Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention

Start date: October 27, 2020
Phase: N/A
Study type: Interventional

Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better.

NCT ID: NCT04532151 Completed - Systemic Sclerosis Clinical Trials

Optical Coherence Tomography Imaging in Systemic Sclerosis

OCTISS
Start date: February 2, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). The severity of skin involvement in SSc is correlated with functional prognosis and survival. To date, there is no validated tool for a reliable quantitative assessment of skin fibrosis. Optical coherence tomography (OCT) is an innovative non-invasive skin imaging technique that allows micrometric analysis of the superficial layers of the skin. Previous study showed that OCT could detect the loss of the dermal-epidermal junction in an objective and non-invasive way, which is correlated with severity of skin fibrosis. The aim of OCTISS study is to evaluate the skin involvement of patients with early SSc using OCT imaging. This will be early diagnosis of fibrosis lesions and help identify patients at an early stage.

NCT ID: NCT04523506 Completed - Scleroderma Clinical Trials

The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma

Start date: May 8, 2020
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the use of botulinum toxin for microstomia (also known as reduced oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study will include three arms: the temporomandibular joint (TMJ) group who will receive injections of Botox to the masseter, the perioral group who will receive injections of Botox around the lips, and a control group who will receive no treatment for ROA. Outcome measurements will include measurement of oral aperture size through measurement inter-labial distance and between the upper and lower lips and the inter-incisal distance, patient satisfaction via a Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The maximum number of subjects to be consented for this study is 30. The study is expected to last four months per subject from time of consent to last clinical evaluation. Conditions that may result in a subject exiting the study prior to completion date include non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result of treatment.

NCT ID: NCT04484948 Completed - Systemic Sclerosis Clinical Trials

Utility of Breath-holding Test in Systemic Sclerosis

Start date: August 12, 2020
Phase: N/A
Study type: Interventional

This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

NCT ID: NCT04481984 Completed - Rehabilitation Clinical Trials

Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis

Start date: July 15, 2016
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a heterogeneous autoimmune disease characterized by fibrosis of the skin and internal organs. Hand involvement is one of the most observed musculoskeletal involvements in patients with SSc, which can impact on general health, quality of life, and psychological status. Hand exercise programs can help patients to improve not only hand function but also general health status; nevertheless, further randomized control trials (RCTs) are needed to clarify its effect. Hence, the investigators aimed to investigate the effectiveness of home-based, self-administered exercise program for hands in patients with SSc and demonstrate the improvements in general health status.

NCT ID: NCT04440592 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Start date: February 5, 2021
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52

NCT ID: NCT04411498 Completed - Fibromyalgia Clinical Trials

Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

Start date: January 2, 2019
Phase:
Study type: Observational

Systemic sclerosis [SSc]; is a multisystem disease characterized by immune activation, microvascular disease and fibroblast dysfunction, which is thought to occur as a result of complex and not fully understood interaction between genetic and environmental factors, leading to fibrotic changes in the skin and some internal organs. It is characterized by the deposition of collagen and other matrix components in the skin and some internal organs. It has been shown by evaluating the health assessment questionnaire that it causes disability with increasing frequency over time. Although pain cannot be localized too well to be attributed to a particular anatomical area, there are several musculoskeletal pain syndromes that can be detected in patients with systemic sclerosis. These are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and fibromyalgia. While there are several studies on others, the relationship between fibromyalgia syndrome and SSc is not known clearly. As with other connective tissue diseases, fibromyalgia is not considered to be rare in SSc.