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Fibrosis clinical trials

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NCT ID: NCT05433467 Recruiting - Clinical trials for Hepatocellular Carcinoma

CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection

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

In this project, the preoperative anatomical location of micro hepatocellular carcinoma under the guidance of CT can provide guidance for accurate surgical resection. It may also shorten the operation time and reduce intraoperative bleeding.

NCT ID: NCT05431946 Enrolling by invitation - Quality of Life Clinical Trials

Palliative Care for Patients With Liver Cirrhosis

LiverCare
Start date: August 1, 2023
Phase:
Study type: Observational

Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment. Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services. Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services. Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status. Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention. Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.

NCT ID: NCT05428826 Recruiting - Clinical trials for Idiopathic Retroperitoneal Fibrosis

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis

METRO
Start date: November 25, 2022
Phase: Phase 4
Study type: Interventional

Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.

NCT ID: NCT05428267 Recruiting - Clinical trials for Sexual Dysfunction in Patients With Cirrhosis Awaiting Liver Transplantation

Sexual Dysfunction in Cirrhosis

SEDYC
Start date: May 26, 2023
Phase: N/A
Study type: Interventional

The prevalence of erectile dysfunction (ED) is about 10% in the general population, but increases with age, ranging from 9.1% in men 40-49 years to 55% in men >70. The major risk factors for ED are as follows: diabetes; heart conditions; tobacco use; obesity; injuries to the nerves that control erection; medications such as antidepressants; psychological conditions such as stress, anxiety, or depression; and drug or alcohol use (4). The International Index of Erectile Function (IIEF5) is a simple and well-validated tool for the evaluation of ED (5) and is considered the gold standard for the diagnosis and evaluation of symptom severity. The link between cirrhosis and ED has been suggested in a recent study, showing ED was also impacted by liver failure, portal hypertension and other known risk factors. In the investigators team, they showed, additionally, that neurocognitive impairment is associated with ED in cirrhosis (data not published). The prevalence of ED after liver transplantation (LT) varies among series, ranging from 66 to 86%. After LT, on the one hand, improvement of liver function and bioavailable testosterone favours the improvement of ED. On the other hand, immunosuppressive agents are suspected to worsen it. ED's reversibility has also been discussed; nevertheless, data are scarce and heterogeneous. In the investigators group, they can perform in routine a neurocognitive evaluation of patients with cirrhosis thanks to a neuropsychologist experienced in cognitive disorders occurring in patients with cirrhosis. The aims of this study are: 1) to compare the prevalence of erectile dysfunction (ED) in a population of patients with cirrhosis before liver transplantation (LT) and one year after LT; (2) to describe factors associated with ED before and after LT, with a special focus of hormonal profile, neurocognitive impairment, multimodal brain Magnetic resonance imaging (MRI) and of the type of immunosuppressive therapy used; (3) to assess the impact of ED on sexual partner; (4) to evaluate the efficacy of the treatment with phosphodiesterase-5 inhibitors (PDE-5) drugs after LT. Methods: neurocognitive tests will be performed by an expert neuropsychologist. Biological evaluation will include an evaluation of liver function, hormonal assessment (bioavailable testosterone). MRI acquisition protocol will include anatomical sequences (3D-T1, FLAIR, T2, T2 *), diffusion tensor imaging (DTI) and two single voxel MR spectroscopy acquisitions. Evaluation will be performed before LT and 1 year after LT.

NCT ID: NCT05424887 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis

Start date: July 2022
Phase: Phase 2
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, multi-center phase II clinical study conducted in China to compare the efficacy and safety of two different dose groups of AK3280 in IPF patients compared to the placebo control group.

NCT ID: NCT05422222 Active, not recruiting - Cystic Fibrosis Clinical Trials

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

Start date: June 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

NCT ID: NCT05420844 Active, not recruiting - Cystic Fibrosis Clinical Trials

Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis

Start date: July 29, 2022
Phase: N/A
Study type: Interventional

The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.

NCT ID: NCT05420753 Recruiting - Sarcopenia Clinical Trials

Body Composition Changes After TIPS and Associated Clinical Outcomes

Start date: May 1, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to prospectively assess the impact of TIPS creation on muscle mass and physical function in patients with cirrhosis, and to determine whether these changes correlate with improved outcomes in patients awaiting liver transplantation. Retrospective observational studies have shown improvement in muscle mass and body composition in cirrhotic patients undergoing TIPS. The investigators aim to now prospectively study this through a pilot randomized controlled trial tracking patients managed with TIPS creation compared to those managed without TIPS to determine whether these observational findings can be seen in a randomized cohort. The investigators hypothesize that TIPS creation will lead to improved muscle mass, body composition and muscle function within the first 12 months after the procedure compared to a control group without TIPS, and that these changes will improve liver disease outcomes in patients awaiting liver transplantation.

NCT ID: NCT05413083 Active, not recruiting - Cirrhosis Clinical Trials

Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis

DYNACORD-AD
Start date: June 6, 2022
Phase:
Study type: Observational [Patient Registry]

This project aims to investigate cardiac function in patients with cirrhosis in the acute setting. Acute decompensation and acute-on-chronic liver failure are major events in the life of a patient as they herald disease progression and negative prognosis. Cardiocirculatory function will be assessed by serial assessments in patients admitted for acute decompensation of cirrhosis.

NCT ID: NCT05408910 Not yet recruiting - Cystic Fibrosis Clinical Trials

Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis

Start date: July 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Gastrointestinal symptoms are commonly reported in as much as 65% of people with CF even independent of pancreatic enzyme replacement therapy (PERT) and the most frequent of these symptoms are bloating/distension, flatulence, abdominal pain and bowel habit changes. An alteration in the intestinal microbiome due to intestinal dysmotility, inflammation or other changes including pH changes in the intestine related to CFTR gene mutation may cause intestinal dysbiosis leading to a bacterial overgrowth in the proximal small intestine which may explain some of the findings of distension and bloating in CF. Our small pilot study aims to investigate use of the only FDA-approved antibiotic, rifaximin for a GI syndrome- IBS, to treat bloating and global GI symptoms in CF patients with bloating and distension. Our goal is to recruit patients >12 years and age/sex matched into rifaximin and placebo arms with total of 100 recruited subjects recruited.