Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Age ≥ 18 years old.
- - Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria.
- - Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion.
- - Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
- - Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
- - Patient capable of performing functional exploration during the year.
- - Affiliation to a social security system.
- - Patient who has given free and informed consent.
- - Any other connectivity associated to systemic sleroderma.
- - Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
- - All known fibrotic and/or obstructive respiratory pathologies.
- - Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria.
- - Diagnosis of left heart disease.
- - Cumulative smoking > 10 packs.
- - Infectious pneumonia within 90 days prior to inclusion.
- - Acute respiratory illness requiring hospitalization within one year prior to inclusion.
- - Pregnant or breastfeeding woman.
- - Refusal to participate in the study.
- - Refusal to use the data.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Tours|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Case group
The intervention of the research corresponds to the realization of a thoracic echography.
Other: - thoracic echography
The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.