View clinical trials related to Fibrosis.
Filter by:This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.
Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study.
General description of the study This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF. Primary objective The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19. Secondary objective To evaluate the efficacy of the initial treatment with SVF IV.
Newborn bloodspot screening (from now on referred to as screening) for cystic fibrosis (CF) became part of the national screening programme in 2007. Screening for CF is also well established internationally. The current process works well but has some disadvantages: carrier reporting - which is not the intention of CF screening in the UK (~200 pa); need for repeat samples which can be costly and contribute to parental worry (~300 pa.); mutation panels not fully reflecting the ethnic diversity of the birth population; identification of children designated as CF screen positive, inconclusive diagnosis (CFSPID) which can cause uncertainty (~20-30 pa). A trial of NGS in one centre in the UK, for one year found that it was technically feasible at reasonable cost and with an acceptable turn around time. In addition, the trial determined that using NGS could mitigate against some of the disadvantages described above. The purpose of this piece of work was to: 1. Gather, compare and analyse the views of a range of stakeholders on the proposed CF screening protocol incorporating NGS. 2. Use the outcomes to inform discussions and decisions by the fetal, maternal and child health (FMCH) group and UK National Screening Committee (NSC) about the proposed protocol 3. Consider what generalisable information on the views of stakeholders on newborn screening could be generated from this exercise to inform other FMCH and UK NSC discussions 4. Evaluate and learn from the exercise to inform future stakeholder engagement activities by the UK NSC and screening programmes.
The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.
The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis
This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed.
The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who maintain sedentary lifestyles. The primary research question is: 1) What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients? Additionally, the secondary research questions are: 1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients? 2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients? Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their sedentary lifestyle. The researchers will compare outcomes between these two groups.
The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.
Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers.In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months.