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Fibrosis clinical trials

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NCT ID: NCT06267794 Completed - Cirrhosis, Liver Clinical Trials

Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis.

ODISEA
Start date: June 26, 2015
Phase: Phase 2
Study type: Interventional

This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov.

NCT ID: NCT06243965 Completed - Clinical trials for Lymph Node Metastasis

Is Desmoplastic Stromal Reaction Useful to Modulate Lymph Node Dissection in Sporadic Medullary Thyroid Carcinoma?

DSR-MTC
Start date: January 1, 1997
Phase:
Study type: Observational

The oncologic benefit of lateral neck dissection (LND) during index operation for sporadic medullary thyroid carcinoma (MTC) basing on basal calcitonin (bCT) levels has been questioned due to the potential post-operative complications. This study aims to evaluate desmoplastic reaction (DSR), as predictor of nodal metastases, for definition of surgical strategy. Data from pathological report of MTC after operations between 1997 and 2022 were collected. The primary endpoint of the study was evaluating the risk factors for nodal metastases. The secondary endpoints analyzed the correlations between DSR and nodal metastases and the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of DSR for nodal metastases.

NCT ID: NCT06242951 Completed - Clinical trials for Cystic Fibrosis in Children

Cardiopulmonary Fitness in Children With Cystic Fibrosis Compared to Healthy Children

VOmuco
Start date: January 31, 2023
Phase:
Study type: Observational

Cystic fibrosis is the most common severe genetic disease with autosomal recessive transmission in the Caucasian population. Its prognosis has improved considerably since the creation of Cystic Fibrosis centers (CF centers) and the improvement of symptomatic management (nutrition, antibiotic therapy, transplantation, etc.). Thus, the median survival rate is now 46 years, whereas it was 5 years in 1963. The current challenges for cystic fibrosis patients are therefore twofold: to continue to improve their survival, and to improve their quality of life (QoL) to promote "healthy ageing" with this pathology that begins in childhood. In 1980, the World Health Organization (WHO) stated that functional capacity explorations best reflected the impact of chronic disease on health-related quality of life. Impairment of physical activity is common to chronic diseases, as in cystic fibrosis, where respiratory impairment and denutrition have been shown to contribute to reduced exercise tolerance and increased dyspnoea. Measurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET) is regarded as the gold standard exercise test in the measurement of aerobic exercise capacity. In 2005 Pianosi et al. found that for children with cystic fibrosis, the rate of decline of VO2max measured by CPET was predictive of poorer quality of life. Continuing to study the determinants associated with impaired aerobic fitness in cystic fibrosis offers the hope of considering appropriate therapies to further improve the quality of life of these patients. In recent years, the arrival and widespread use of CFTR protein modulators in children has been a real turning point and makes it possible to envisage a drastic change in the history of this disease and its prognosis in the long term. Thus, in this study, the investigators aimed to assess the aerobic fitness, assessed by a CPET, of children with cystic fibrosis, and to compare the results with healthy controls. Secondly, investigators wanted to identify the predictive factors of VO2max in children with cystic fibrosis.

NCT ID: NCT06238856 Completed - Cystic Fibrosis Clinical Trials

Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa

Start date: May 12, 2004
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.

NCT ID: NCT06179342 Completed - Asthma Clinical Trials

Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Start date: June 21, 2021
Phase:
Study type: Observational

Comparison of the new multiple-breath washout method (ndd Medizintechnik Zürich, Trueflow™/Truecheck™) with established methods of lung function diagnostics in patients with idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, asthma and cardiopulmonary healthy individuals.

NCT ID: NCT06160440 Completed - Pulmonary Fibrosis Clinical Trials

The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects.

Start date: June 3, 2021
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy subjects.Food effect in healthy subjects.Participants will complete the study including screening period, dosing period, and observation period. Researchers will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.

NCT ID: NCT06135363 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

Start date: August 11, 2022
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.

NCT ID: NCT06122025 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Patient Access to People With Cystic Fibrosis (CF) and Healthcare Professionals

Start date: December 11, 2017
Phase: N/A
Study type: Interventional

Cystic fibrosis (CF) is one of the most common inherited conditions in the United Kingdom (UK). There are 10,810 people living with CF in the UK, with median predicted survival now 47 years old. People with CF have multiple medical treatments to do on a daily basis, and the treatment burden is increasing. Adherence to treatment plays an important role in health outcomes and survival in CF. Online access to their own health care records gives people an increased control over their own health, greater understanding of their conditions and has a potential to improve adherence to care plans and medications. Whilst implementation of electronic records is established in primary care, there has been a much poorer roll out of electronic care records in the secondary care system. Leeds Teaching Hospitals CF Unit is a regional centre with around 650 adult and paediatric registered patients. Handwritten and typed paper records of patients under the care of the CF unit in Leeds were replaced in 2007 by electronic healthcare records (EHR; EMIS®). Patients view and obtain graphical feedback at each clinic visit including trends in parameters such as lung function, weight and inflammatory markers. In partnership with Egton Medical Information Systems (EMIS) web (EMIS®), a modification allowing secondary care access to patient records has been developed. In a structured programme of research, the Leeds Adult CF Unit have firstly evaluated the implementation of the EHR in secondary care in terms of service delivery and cost improvement. In the second phase, the investigators sought patient feedback regarding which aspects of their EHR people with CF wish to access, and their priorities for development. This has informed the third phase in which the aim is to explore the impact of patient access to their EHR. The aims of the trial are 1. To evaluate the feasibility, benefits and acceptability to patients and health care professionals of providing secure access of linked secondary care and patient's Personal Health Records in CF, and 2. To explore technological usability, future functionality and the impact of the shared records on clinical resources, communication and patient and health care professional satisfaction.

NCT ID: NCT06112717 Completed - Cystic Fibrosis Clinical Trials

The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis

Start date: February 14, 2019
Phase: N/A
Study type: Interventional

The present study evaluates the effect of nursing care based on the Self-Care Deficit Nursing Theory on the knowledge and skills related to self-care among adolescents with Cystic Fibrosis.

NCT ID: NCT06109675 Completed - Clinical trials for Cystic Fibrosis in Children

Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status

Start date: September 2, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to to assess the nutritional status of children diagnosed with cystic fibrosis between the ages of 2-14, to determine the changes in the nutrition education given to the mothers of the patients on the nutritional status of the children and the nutritional knowledge of the mothers, and to compare them with the control group.. The main questions it aims to answer are: 1. Will be better the nutritional status of children of mothers in the education group will be better compared to the control group? 2. Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of children with cystic fibrosis in education group increase after nutrition education? 3. Will the nutrition knowledge test scores of mothers of children with cystic fibrosis in education group on "Nutrition in Cystic Fibrosis" increase after nutrition education? Mothers of children diagnosed with cystic fibrosis will participate in the study as a result of the call of the Cystic Fibrosis Association in Turkey. Mothers participating in the study will be divided into 2 groups. While the mothers in the first group will be given nutrition education 3 times a week, 1 hour a day, no education session will be given to the mothers in the control group. The nutritional status and nutrient consumption of children in the training group and the control group will be compared.