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Fibrosis clinical trials

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NCT ID: NCT05786755 Completed - Liver Cirrhosis Clinical Trials

Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis

Start date: August 15, 2018
Phase:
Study type: Observational

Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.

NCT ID: NCT05779007 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Start date: April 18, 2023
Phase:
Study type: Observational

The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.

NCT ID: NCT05737433 Completed - NASH With Fibrosis Clinical Trials

Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects

Start date: March 1, 2023
Phase: Early Phase 1
Study type: Interventional

This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of [14C] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.

NCT ID: NCT05724485 Completed - Quality of Life Clinical Trials

Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized controlled trial is to compare the efficacy and safety of branched-chain amino acids (BCAA) versus placebo for treating muscle cramps in cirrhotic patients. The main questions it aims to answer are: - Compared the effect of BCAA versus placebo on muscle cramp frequency in cirrhotic patients - Compared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patients - Compared the effect of BCAA versus placebo on quality of life in cirrhotic patients with muscle cramps Participants with cirrhosis who have experienced muscle cramps at least once per week will be randomized to receive either a placebo or 12.45 grams of BCAA orally per day for 12 weeks.

NCT ID: NCT05719311 Completed - Cystic Fibrosis Clinical Trials

Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis

SPAN
Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis. The main question[s] the study aims to answer are: 1. Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study. 2. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use. Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).

NCT ID: NCT05711290 Completed - Pulmonary Fibrosis Clinical Trials

Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Approximately 1 in 5 (or 12.7 million adults) in the UK have longstanding respiratory illnesses, and 6.5 million patients report taking prescription medication to ease the burden. Many patients suffer from lung tissue damage, which impairs adequate blood oxygenation and reduces blood saturations, and causes breathlessness. The current method of treatment is palliative - with the patient breathing supplemental oxygen through an oxygen cylinder and tube. This severely compromises patients' quality of life, as they are tethered to a heavy, unwieldy oxygen cylinder, limiting their ability and willingness to leave home. Several recent studies in both animals and humans have indicated that orally administered oxygenated nanobubbles is a safe intervention that can improve tissue oxygenation. This randomized, double-blinded, cross-over, placebo-controlled study will evaluate the effect of an oxygen nanobubbles drink on the exercise performance of patients with chronic lung disease, such as pulmonary fibrosis. Patients will conduct the 6 Minute Walk Test (6MWT) twice, once with a placebo drink and once with the oxygen nanobubbles drink, based on a double-blind randomization protocol, and this study will evaluate the distance walked, heart rate, oxygen levels, breathlessness, and time to recovery in both cases. The investigators hypothesize that drinking the oxygen nanobubbles drink will improve the delivery of oxygen to vital organs, improving the distance a patient can cover in the 6 Minute Walk Test by 30m, which is the minimum clinically important difference.

NCT ID: NCT05700604 Completed - Cystic Fibrosis Clinical Trials

Hypoglycemia and Glucagon Response in CF

Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this clinical trial is to investigate the etiopathogenesis of isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance in children with Cystic Fibrosis (CF) and to evaluate the role of glucagon and pancreatic insufficiency on hypoglycemia in CF. The main questions it aims to answer are: 1. Do isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance have different etiopathogenesis? 2. What is the role of pancreatic insufficiency in these two conditions? Participants were asked to perform 3-h OGTT and to take blood samples. Researchers compared with healthy peers to see if there is isolated hypoglycemia in OGTT and how is the glucagon response to OGTT in healthy peers.

NCT ID: NCT05687409 Completed - Cirrhosis, Liver Clinical Trials

Synbiotics Interventions for Managing Cirrhosis and Its Complications

Start date: November 24, 2019
Phase: Phase 4
Study type: Interventional

Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated. Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.

NCT ID: NCT05674877 Completed - Liver Cirrhosis Clinical Trials

Opioid Sparing Anesthesia in Patients With Liver Cirrhosis Undergoing Liver Resection

Start date: December 1, 2022
Phase: Phase 3
Study type: Interventional

This randomized clinical trial will investigate the opioid sparing effect of dexmedetomidine and ketmine infusion in cirrhotic patients undergoing liver resection

NCT ID: NCT05670587 Completed - Pulmonary Fibrosis Clinical Trials

A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

This study is open to adults aged 18 years and older who have pulmonary fibrosis with or without a known cause (or other forms of pulmonary fibrosis). The purpose of this study is to better understand coughing in people with pulmonary fibrosis. To do this, a wearable cough monitor called Strados Remote Electronic Stethoscope Platform (RESP) is used. This device will measure how often and how forceful coughing is in people with pulmonary fibrosis. All participants in the study get the device. It is placed on their skin over the chest. Participants are in the study for 3 months. During this time, they visit the study site 2 to 3 times. 4 visits are done at the participant's home by video call with the site staff. During the study, the device measures coughing over 24 hours. This is done on 4 days. Participants fill in questionnaires about their coughing and doctors regularly check participant's lung function. A breathing test that measures how well the lungs are working is performed both in the office and during home visits. The doctors also regularly check participants' health and take note of any unwanted effects. This study will also record patients' experiences using the cough monitor and video assisted breathing tests at visits 3, 4, 5 and 6 at home.