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Fibrosis clinical trials

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NCT ID: NCT03509194 Recruiting - Liver Cirrhosis Clinical Trials

Better Diagnostic Tools for Children and Adolescents With Acute Liver Failure and Chronic Liver Insufficiency

DAKL
Start date: December 17, 2017
Phase:
Study type: Observational

The aim of this study is to validate and develop a new diagnostic and prognostic approach for assessment of liver function in children and adolescents with acute liver failure and chronic liver insufficiency. A carefully selected panel of functional and genomic tests along with diagnostic imaging and analysis of the microbiota will be performed in children and adolescents with acute liver failure and chronic liver insufficiency at Rigshospitalet. The tests will be performed in a serial manner in order to detect changes in outcomes. The study is an unblinded descriptive study, and approximately 20 patients with acute liver failure and 100 patients with chronic liver disease will be included in the project. This study will be the first of it's kind worldwide. The investigators expect the study to improve future diagnostic and prognostic accuracy and help the clinicians in identifying those patients in which the liver will regenerate itself, from those patients in which a liver transplantation will be lifesaving. Furthermore this study aims to help the clinicians in defining the optimal time for pediatric liver transplant in a narrow window of opportunity.

NCT ID: NCT03506061 Recruiting - Cystic Fibrosis Clinical Trials

Trikafta in Cystic Fibrosis Patients

Start date: September 4, 2019
Phase: Phase 2
Study type: Interventional

This clinical study will enroll 42 participants without the F508del mutation, carrying partial function or N1303K mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the immediate future. Each participant will be given Trikafta for approximately four weeks. The study researchers will monitor clinical endpoints that include forced expiratory volume (FEV1) and sweat chloride. Additionally, the researchers will obtain skin biopsy material and/or blood sample from each subject so that induced pluripotent stem (iPS) cells can be modified into airway cell monolayers and tested for response to Trikafta. In this way, the study will evaluate an emerging and readily accessible in vitro endpoint as a predictor of clinical response. This study will serve as a pilot/test case for other clinical protocols relevant to patients with rare CFTR variants who do not currently receive modulator therapies. It is hypothesized that a robust correlation will be established between in vitro Trikafta responsiveness of iPS cells and in vivo benefit (FEV1) to patients, and will provide a new tool for utilizing iPS to identify patient populations most suitable for cystic fibrosis modulator therapy.

NCT ID: NCT03500731 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure

Start date: April 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.

NCT ID: NCT03487861 Recruiting - Clinical trials for Kidney Transplant Failure and Rejection

Urinary Transglutaminase 2 as a Biomarker for Kidney Allograft Fibrosis

Start date: August 29, 2017
Phase:
Study type: Observational

The aim of this study is to verify the ability of transglutaminase type 2 to predict rejection or chronic allograft nephropathy of renal allograft. On the basis of biomolecular mechanisms aggravating chronic allograft nephropathy, we eventually expect to develop the remedy to prevent chronic allograft nephropathy after kidney transplantation.

NCT ID: NCT03485456 Recruiting - Cystic Fibrosis Clinical Trials

DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis

Start date: May 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The goal is to investigate the pharmacokinetic properties of dry powder tobramycin via the Cyclops® at different dosages in children with cystic fibrosis, together with the local tolerability.

NCT ID: NCT03478553 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis (IPF)

The Genetics of Pulmonary Fibrosis

Start date: January 18, 2018
Phase:
Study type: Observational

This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.

NCT ID: NCT03472157 Recruiting - Obesity Clinical Trials

A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients

NASHSURG
Start date: June 20, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² > BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).

NCT ID: NCT03470389 Recruiting - Liver Cirrhosis Clinical Trials

Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM)

HVPGBFM
Start date: March 20, 2018
Phase: N/A
Study type: Interventional

This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics methods and validate the HVPGBFM model. A total of 200 patients will be recruited in this study and each patient will undergo computed tomography, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (100 patients) and validation cohort (100 patients). The researchers will establish and improve the HVPGBFM model in the original cohort and assess the model in the validation cohort.

NCT ID: NCT03437876 Recruiting - Cirrhosis, Liver Clinical Trials

Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis

Start date: October 31, 2016
Phase: N/A
Study type: Interventional

Chronic hepatitis B (CHB) is a common infectious disease affecting up to 2 billion people worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis B every year. 3%-5% compensatory liver cirrhosis develop to decompensated cirrhosis and suffer from series symptoms such as fatigue, edema, portal hypertension, splenomegaly, hemorrhage, hepatic encephalopathy, hepatorenal syndrome and so on. Chronic hepatitis B is closely related to the imbalance of intestinal microbiota, and the intestinal microbiota of patients is significantly different from healthy people. The response of patients to hepatitis B virus can be influenced by reconstructing intestinal flora, while Intestinal microbiota transplantation(IMT) is a significant method to achieve it. In a previous study using IMT to treat HBeAg positive chronic hepatitis B patients combined with antiviral therapy, 80% of them has reached HBeAg clearance. The investigators propose a randomized trial of IMT in patients with HBV induced cirrhosis. Patients will be randomized to either control group or IMT group over a 12 months period.

NCT ID: NCT03437486 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Mechanisms of Familial Pulmonary Fibrosis

Start date: January 1, 2009
Phase:
Study type: Observational

This a prospective, longitudinal study of first-degree family members of patients diagnosed with familial interstitial pneumonia (FIP). FIP is the familial form of idiopathic pulmonary fibrosis (IPF), which is defined as 2 or more bloodline relatives which have a diagnosis of idiopathic interstitial pneumonia (IIP). The most common form of idiopathic interstitial pneumonia in FIP families is IPF (approximately 70%). The inheritance pattern in FIP is consistent with autosomal dominant inheritance with incomplete penetrance. Therefore, individuals in this study have approximately 50% risk of carrying a disease-associated allele. The causative gene is currently only known approximately 20% of families. The main goal of this longitudinal study is to better establish the natural history of FIP and to identify risk factors for later development of symptomatic disease. The investigators' plan is to follow these at-risk individuals with yearly questionnaires and planned in person 2 year follow-ups through age 75 or until they develop symptomatic FIP.