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Scleroderma, Systemic clinical trials

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NCT ID: NCT06231433 Completed - Systemic Sclerosis Clinical Trials

Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

SCLERDERMCO2
Start date: May 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days. At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.

NCT ID: NCT06095921 Completed - Systemic Sclerosis Clinical Trials

The Effect of a Self-Management Program on Individuals With Scleroderma

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Introduction: Individuals with systemic sclerosis (SSc) have problems with perceived occupational performance and satisfaction in daily life activities due to many symptoms caused by the disease. Purpose: This study will plan to examine the effect of a self-management program for individuals with SSc on perceived occupational performance and satisfaction. Materials and Methods : Twenty-nine individuals with SSC, 28 females and 1 male will participate in the study. Perceived occupational performance and satisfaction levels before and after the program will evaluate with the Canadian Ocupational Performance Measure (COPM). The training programme will design according to the activities of COPM, the needs of the patients, and the literature. The programme consists of 8 sessions for 8 weeks, 1 day a week for 45 minutes.

NCT ID: NCT06037577 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

Start date: March 5, 2019
Phase: Phase 1
Study type: Interventional

CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.

NCT ID: NCT06032754 Completed - Clinical trials for PSVD With or Without SSc

PortoSinusoidal Vascular Diseases and Systemic Sclerosis

Start date: February 1, 2023
Phase:
Study type: Observational

Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.

NCT ID: NCT05963048 Completed - Clinical trials for Interstitial Lung Disease

Rituxmab Versus IL-6 in Treating ILD

Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

NCT ID: NCT05907200 Completed - Systemic Sclerosis Clinical Trials

Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are: • Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life? Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if: • Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?

NCT ID: NCT05622578 Completed - Clinical trials for Scleroderma, Systemic

Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

PAIN SSc
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain. As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.

NCT ID: NCT05617066 Completed - Scleroderma Clinical Trials

Stress, Scleroderma and Quality of Life

Start date: November 26, 2022
Phase: N/A
Study type: Interventional

150 patients of legal age will participate in this project, diagnosed with systemic sclerosis. Patients will be randomly assigned, as will be detailed later, to one of the following three groups: Therapy Group (GT): This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress (online modality) in groups of 10-12 people during twelve sessions Consecutive weekly courses of 1.5 to 2 hours duration taught by psychology professionals. of this mode 4 subgroups will be made. Psychological Support Group (AP): This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma. It will have a duration of twelve weekly sessions. Consecutive sessions of 1.5 to 2 hours in length taught by professional psychologists. In this way they will 4 subgroups. Usual Care Group (CG): This group will be made up of 50 patients who will follow their usual care. Later, once the study is over, they will be offered to participate in coping with stress to the person who is interested.

NCT ID: NCT05453071 Completed - Systemic Sclerosis Clinical Trials

The Effect of Cognitive Exercise Therapy Approach in Individuals With Systemic Sclerosis

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis and to present a named exercise model for this disease group with objective results.

NCT ID: NCT05171114 Completed - Clinical trials for Scleroderma, Systemic

Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

SCLERO-HAND
Start date: December 28, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.