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Fibrosis clinical trials

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NCT ID: NCT03104855 Completed - Cystic Fibrosis Clinical Trials

Clearance of 25-hydroxyvitamin D in Cystic Fibrosis

CF
Start date: April 3, 2017
Phase: Phase 1
Study type: Interventional

The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of this work is to provide the first comprehensive characterization of vitamin D metabolism in CF patients and promote novel hypotheses for subsequent studies.

NCT ID: NCT03104322 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis

Start date: June 15, 2017
Phase: N/A
Study type: Interventional

Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of patientMpower platform from patient & healthcare professional perspective, impact of active engagement and self-monitoring using patientMpower platform on Patient Reported Outcome Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and correlation between patient-reported PROMs & FVC and clinical outcomes.

NCT ID: NCT03100214 Completed - Cystic Fibrosis Clinical Trials

Effects of an Early Rehabilitation Program During Hospitalization in Patients With Cystic Fibrosis

Start date: August 2016
Phase: N/A
Study type: Interventional

Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen consumption, reduce effort-induced lactic acid production, and increase skeletal muscle oxidative capacity, as well as psychological aspects such as increased self-esteem and improvement of the quality of life. In the literature there is only one study involving rehabilitation in hospitalized pediatric patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is required in adult cystic fibrosis patients. The present study aims to evaluate the effects of an early rehabilitation program, based on aerobic training and muscle strength training, in adolescent and adult patients with cystic fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung disease.

NCT ID: NCT03093974 Completed - Clinical trials for Non Cystic Fibrosis Bronchiectasis

Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)

PROMIS-I
Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

The objective of the trial was to investigate the effect of the use of inhaled CMS, administered b.i.d. via a specific nebuliser for 12 months, compared to placebo in subjects with NCFB chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.

NCT ID: NCT03093714 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects

Start date: August 23, 2017
Phase: Phase 1
Study type: Interventional

This is a multicenter, randomized, placebo-controlled, dose-escalation study. Enrollment is planned to occur at approximately 14 global sites. Approximately 24 subjects with CF.

NCT ID: NCT03091738 Completed - Cirrhosis Clinical Trials

Ramelteon for Treatment of Insomnia in Cirrhosis

Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

To study the effect of ramelteon, a melatonin receptor agonist, on sleep quality, duration and cognitive function in cirrhotics with insomnia. Patients with cirrhosis have difficulties with their sleep quality, which adversely affects their health-related quality of life. It is assumed the sleep disturbances are related to hepatic encephalopathy (HE) in these patients. However, several recent reports have indicated that this is not a perfect concordance and that cognition is not related to sleep disturbance. The mechanism for this change is not clear, although there is evidence of melatonin-delayed phase in these patients as well as difficulties with the excretion pattern of cortisol. Ghrelin is an orexigenic hormone produced by the stomach which stimulates the appetite and also has a profound effect on sleep. Our group has demonstrated a substantial alteration in ghrelin secretion in cirrhosis that correlates with poor slow-wave sleep. In healthy individuals, ghrelin injection encourages slow-wave sleep while sleep deprivation increases ghrelin levels. The role of ghrelin in the sleep disturbances of cirrhosis has not been determined. Prior studies have also lacked the use of overnight polysomnography as a tool and have relied on either actigraphy or questionnaires. There is a need for detailed mechanistic and therapeutic approaches to analyzing sleep disturbances in cirrhosis. Also the therapy of sleep disturbance in cirrhosis is largely empirical. Prior studies have evaluated hydroxyzine which runs the risk of precipitating HE. Ramelteon is a melatonin analog that is FDA-approved for use in insomnia and will potentially be useful to restore the sleep-wake cycle in cirrhosis-associated sleep disturbance. The investigators aim to study the impact of the FDA-approved ramelteon on the sleep quality (using questionnaires and sleep diaries) on these patients with cirrhosis.

NCT ID: NCT03089944 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

EXPEDITION-8
Start date: April 28, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

NCT ID: NCT03088917 Completed - Chronic Hepatitis c Clinical Trials

'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'

Track&Trace
Start date: September 27, 2017
Phase:
Study type: Observational

Objective: To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options. Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.

NCT ID: NCT03087344 Completed - Clinical trials for Chronic Liver Disease

Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.

NCT ID: NCT03078426 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Lung MRI in the Management of Idiopathic Pulmonary Fibrosis

PIC'IRM
Start date: February 16, 2017
Phase: N/A
Study type: Interventional

High resolution computed tomography (HRCT) plays a major role in the management of idiopathic pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural alterations using a non invasive technique, it is nonetheless a radiating exam which provides limited functional information regarding inflammation. In this trial, the investigators aimed to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an alternative to HRCT in the assessment of the four morphological criteria required to define an UIP pattern. The investigators also planned to study the clinical value of the additional informations derived from MRI such as contrasts and lung perfusion using functional MRI.