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Fibrosis clinical trials

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NCT ID: NCT06076330 Not yet recruiting - Liver Cirrhosis Clinical Trials

Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

Cirrhotic patients with sepsis represent a very sick subset of patients and septic shock in such patients is associated with high mortality. Early initiation of intravenous fluids and antibiotics is the key to management in these patients. The choice of fluid in cirrhotic patients with sepsis induced hypotension has been studied in the past. The choice of fluid, crystalloid vs colloid, for resuscitation in such patients has been a matter of debate. In the previous study, the ALPS trial, 20% albumin use was associated with a better reversal of hypotension but was associated with an increased incidence of pulmonary complications and 5% albumin was better when compared to normal saline(FRISC study) for fluid resuscitation. No study in the past has evaluated 5% albumin against 20% albumin in combination with crystalloid. Investigator aim to study the efficacy and safety of 20% albumin with plasmalyte against 5 % albumin for fluid resuscitation in cirrhotic patients with sepsis induced hypotension.

NCT ID: NCT06069947 Not yet recruiting - Liver Cirrhosis Clinical Trials

SALT for Liver Cirrhosis With HCC

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

HCC is the third leading cause of cancer deaths worldwide. Although surgical treatment may be effective in patients with HCC, the five-year survival rate is only 50-70%. Moreover, due to the lack of early diagnostic marker, most patients with HCC are often diagnosed in an advanced stage with poor prognosis. Therefore, there is an urgent need to further understand the possible aetiological factors and surgical treatment methods to improve the prognosis of patients with HCC. Liver transplantation is an ideal choice for patients with liver cirrhosis with HCC, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of patients with liver cirrhosis with HCC. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.

NCT ID: NCT06066723 Not yet recruiting - Clinical trials for Cystic Fibrosis in Children

19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

Start date: June 2024
Phase:
Study type: Observational

This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children. Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.

NCT ID: NCT06057870 Not yet recruiting - Clinical trials for Liver Cirrhosis, Alcoholic

Feasibility of Wearable Biosensors for Monitoring Daily Activity, Heart Rate, and Sleep Among Patients With Decompensated Cirrhosis

Start date: April 10, 2024
Phase:
Study type: Observational

In this protocol, the investigators will determine compliance, acceptability, and patient satisfaction regarding the use of remote monitors and summarize changes in activity over time among patients with decompensated cirrhosis. This is a feasibility pilot study that will recruit 20 patients. The investigators plan to determine the feasibility of wearable devices to remotely monitor daily activity (e.g., physical activity, sedentary time, sleep), cognitive function, blood pressure, and weight in patients with decompensated cirrhosis, by assessing patient compliance. A patient is considered compliant if they wear the wristwatch at least 10 hours per day and use the Apps, body weight scale, and blood pressure monitor for at least 4 of 7 days

NCT ID: NCT06050993 Not yet recruiting - Liver Cirrhosis Clinical Trials

Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis

HEMCITAP
Start date: October 15, 2023
Phase:
Study type: Observational

Haemostasis of cirrhotic patients is disturbed at different levels: primary haemostasis, coagulation and fibrinolysis, leading to a new haemostatic balance. Thrombocytopenia and thrombopathy are counterbalanced by elevation of Von Willebrand factor (VWF) and diminution of ADAMTS13 activity. Exploration of primary haemostasis is difficult in the laboratory, and non-interpretable in case of thrombocytopenia. Moreover, these tests are not performed under flow conditions. The T-TAS®01 system analyses the total haemostatic capacity in whole blood under shear stress, with chips coated with type 1 collagen. Platelets transfusion performs poorly in cirrhotic patients and is not recommended before invasive procedure. Platelets mimicking nanoparticles (PMNs) have been developed by Pr Sen Gupta (Case Western Reserve University, Cleveland, Ohio (OH), USA). PMNs have been proven to collaborate with platelets and enhance haemostasis in different shear conditions in vitro and in different models of haemorrhage in vivo. The assumption of this study is that the perfusions characteristics of cirrhotic patients in the T-TAS®01 system will be different from those of non-cirrhotic patients, and that platelets mimicking nanoparticles will improve these characteristics.

NCT ID: NCT06049004 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients

Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

The Londrina Activities of Daily Living Protocol was first developed for Chronic Obstructive Pulmonary Disease patients and was found to be valid and reliable, but there is no validity and reliability study of the Londrina Activities of Daily Living Protocol in IPF patients. The purpose of the study is to Examine the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis (IPF) patients.

NCT ID: NCT06035055 Not yet recruiting - Cystic Fibrosis Clinical Trials

Ceftolozane/Tazobactam Continuous Infusion for Infective Exacerbations of Cystic Fibrosis and Bronchiectasis

CERTAIN
Start date: October 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to assess the feasibility of ceftolozane/tazobactam (C/T) administered on an outpatient parenteral antibiotic therapy programme to patients with a current infective exacerbation of bronchiectasis or cystic fibrosis related to pseudomonas aeruginosa or burkholderia cepacia spp. organisms. The main question[s] it aims to answer are: - Is C/T effective, safe, well-tolerated and able to induce clinical and microbiologic response? - What are mechanisms of antimicrobial resistance are induced by administration of C/T?

NCT ID: NCT06026267 Not yet recruiting - Liver Cirrhosis Clinical Trials

Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis

Start date: September 5, 2023
Phase: N/A
Study type: Interventional

The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined, which decreases the morbidity and mortality. However the conventional dose recommended by the guidelines is usually not tolerated by the Indian population. Investigator propose that the low dose is as beneficial as the standard dose in patients with high risk SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk spontaneous bacterial peritonitis. If confirmed, these results could support a significant cost reduction in the management of ascites in cirrhotic patients and decrease the side effects of the volume overload in the patient of the cirrhosis.

NCT ID: NCT06022237 Not yet recruiting - Liver Cirrhosis Clinical Trials

Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Hepatic osteodystrophy(HOD) is a common but frequently overlooked complication of liver cirrhosis with a prevalence rate ranging from 13-70%. Bisphosphonates acting by inhibiting bone resorption are frequently used. Intravenous infusions of bisphosphonates may cause prolonged arthralgia and myalgia whereas oral bisphosphonates may cause digestive mucosal damage causing dysphagia, esophagitis and ulcer. Such side effects have discouraged the prescription of oral bisphosphonates for patients of cirrhosis mainly due to risk of upper GI hemorrhage arising from esophageal variceal rupture. All studies done in past with bisphosphonates are either open labelled RCT/ non- randomized control trial or have enrolled patients of primary biliary cirrhosis only. So, there is a need to have double blind RCT assessing efficacy and safety of oral bisphosphonates in non-cholestatic liver cirrhosis. In this study, we hypothesize that oral ibandronate significantly improves BMD in patients of liver cirrhosis & is safe in patients with low risk esophageal varices. With this study, we aim to assess the efficacy and safety of oral ibandronate in patients of liver cirrhosis with hepatic osteodystrophy

NCT ID: NCT06021860 Not yet recruiting - Clinical trials for Edema Due to Heart Failure or Cirrhosis

A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients

Start date: June 2024
Phase: Phase 4
Study type: Interventional

This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis. Both study parts will evaluate the safety, PK and PD of multiple doses of spironolactone in patients aged from birth to ≤17 years of age.