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Fibrosis clinical trials

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NCT ID: NCT05012306 Active, not recruiting - Cystic Fibrosis Clinical Trials

Covid-19 Antibody Responses in Cystic Fibrosis

CAR-CF
Start date: May 28, 2021
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The investigators will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. As pwCF receive COVID-19 vaccination the investigators will perform a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time.

NCT ID: NCT05010577 Active, not recruiting - Cystic Fibrosis Clinical Trials

Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

Start date: June 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.

NCT ID: NCT04999865 Active, not recruiting - Cystic Fibrosis Clinical Trials

Cystic Fibrosis Reproductive and Sexual Health Collaborative: Building Online Research Partnerships

Start date: April 19, 2019
Phase:
Study type: Observational

This is a Patient-Centered Outcomes Research Institute engagement effort aimed at training researchers/providers and patients to work in research teams together online throughout the research process (including: development, design, and dissemination) to address critical gaps in their care. This is a change from the typical research done with people with CF as they are frequently isolated from other members of the CF community because of infection control guidelines that restrict in-person contact to avoid the spread of bacteria between patients. This project has four aims: 1. build capacity for PCOR knowledge and skills applicable for longitudinal online engagement, 2. create and disseminate a best practices PCOR user guide for populations that solely engage online, 3. to create an interactive web-based version of our User Guide through a survey and three modified Delphi rounds, and 4. to create a comprehensive training manual for conducting PCOR online (step-by-step instructions), which will incorporate the aforementioned user guide.

NCT ID: NCT04998500 Active, not recruiting - Fibrosis Clinical Trials

Growth Hormone as a Model for Reversible Activation of Adipose Tissue Fibrosis

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Background: Adipose tissue fibrosis denotes excessive pathological accumulation of extracellular matrix (ECM) in adipose tissue and is a marker of dysfunction. Growth hormone (GH) activates adipose tissue lipolysis and stimulates collagen synthesis in lean tissues. Intriguingly, we have novel pilot data to suggest that GH excess (acromegaly) also induces reversible fibrosis in vivo and potently activates the expression of fibroblast activation protein alpha (FAPα). Hypothesis: GH induces adipose tissue fibrosis by increased FAPα expression together with proliferation and fibrogenic differentiation of fibro-adipogenic progenitor (FAP) cells. Aim: To unravel the mechanisms underlying GH-induced adipose tissue fibrosis with emphasis on FAPα expression and proliferation of FAP cells. Subjects and methods: In a single blinded, randomized, double-dummy crossover design, 10 adult, moderately overweight individuals will be subjected to one week of GH and GH receptor blockade (Pegvisomant). We will use single-cell technologies, fluorescence-activated cell sorting (FACS), RNA sequencing, and cell culture studies on adipose tissue samples, combined with in vivo assessment of adipose tissue turnover and metabolism. Perspectives: Understanding fibrosis formation in human models may identify new targets for treatment of obesity-associated disorders.

NCT ID: NCT04992234 Active, not recruiting - Covid19 Clinical Trials

COVID-19 Antibody Responses in Cystic Fibrosis

CAR-CF
Start date: August 31, 2021
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. We will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination we will perform a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time.

NCT ID: NCT04987528 Active, not recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Pulmonary Fibrosis During Severe COVID-19 Pneumonia

FIBRO-COVID
Start date: March 11, 2020
Phase:
Study type: Observational

The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), an emerging coronavirus, which has already infected 192 million people with a case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have a critical form with organ failure. Among critical patients admitted to intensive care, about 70% of them will require ventilatory assistance by invasive mechanical ventilation (MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severe lung damage resulting from SARS CoV-2 infection is the acute respiratory distress syndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelial cells leading to an activation of endothelium, hypercoagulability and thrombosis of pulmonary capillaries. This results in abnormal ventilation / perfusion ratios and profound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonia lay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist, which both reduce the need of MV and mortality. The risk factors of death in Intensive Care Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer, severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, the death rate is doubled in those with both reduced thoracopulmonary compliance and elevated D-dimer levels. Patients with severe alveolar damage are at risk of progressing towards irreversible pulmonary fibrosis, the incidence of which still remain unknown. The diagnosis of pulmonary fibrosis is based on histology but there are some non-invasive alternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim to assess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 related pneumonia. We will investigate the prognostic impact of fibrosis on mortality and the number of days alive free from MV at Day 90. Finally, we aim to identify risk factors of fibrosis.

NCT ID: NCT04974255 Active, not recruiting - Thyroid Fibrosis Clinical Trials

Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. In our study we tried to find if there is any correlation in between Anti-tTG and degree of fibrosis in thyroid tissue (Post-operative specimen).

NCT ID: NCT04939441 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

Start date: April 20, 2021
Phase: Phase 4
Study type: Interventional

Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). All enrolled subjects will be treated with TAF monotherapy for 96 weeks. After 96 weeks of therapy, the second liver biopsy will be performed to evaluate the rate of liver fibrosis regression. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.

NCT ID: NCT04904445 Active, not recruiting - Cystic Fibrosis Clinical Trials

COVID-19 Antibody Responses In Cystic Fibrosis

CAR-CF
Start date: May 21, 2021
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.

NCT ID: NCT04895943 Active, not recruiting - Obesity Clinical Trials

Bariatric Endoscopy and NAFLD

Start date: April 29, 2021
Phase:
Study type: Observational

Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.