Name (Synonyms) | Correlation | |
---|---|---|
drug433 | CFTR Modulators Wiki | 0.45 |
drug1543 | N-acetylcysteine+Placebo Wiki | 0.45 |
drug2601 | Unsupervised exercise Wiki | 0.45 |
drug1542 | N-acetylcysteine+ Fuzheng Huayu Tablet Wiki | 0.45 |
drug869 | Esomeprazole 20mg Wiki | 0.45 |
drug880 | Exercise Wiki | 0.32 |
drug1243 | Interview Wiki | 0.26 |
drug1978 | Questionnaire Wiki | 0.09 |
drug1822 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D003550 | Cystic Fibrosis NIH | 0.52 |
D008103 | Liver Cirrhosis, NIH | 0.45 |
D011658 | Pulmonary Fibrosis NIH | 0.20 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001395 | Hepatic fibrosis HPO | 0.45 |
HP:0002206 | Pulmonary fibrosis HPO | 0.20 |
There are 5 clinical trials
Inflammation is the early stage of fibrosis. Serious patients are more likely to develop into pulmonary fibrosis, which affects the recurrence of lung function or even threatens life and health. This study is planned to observe the efficacy and safety of Fuzheng Huayu tablets in the treatment of pulmonary fibrosis after COVID-19.
Description: Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.
Measure: High-resolution computed tomography (HRCT) score Time: Week 24Description: Evaluation of Lung Function Improvement
Measure: Lung function including FVC, FVC as a percentage of projected value and DLco Time: Week 24Description: Times of acute exacerbations during treatment
Measure: Times of acute exacerbation Time: Week 24Description: Measured by a 6-minute walking test
Measure: Six-minute walk distance Time: Week 24Description: Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
Measure: Dyspnea Scores Time: Week 24Description: Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.
Measure: Composite physiological index Time: Week 24COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Description: 7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis
Measure: All-cause mortality of COVID-19 patients with liver cirrhosis Time: From illness onset of COVID-19 to death from any cause, up to 365 daysDescription: 7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis
Measure: Liver-related mortality of COVID-19 patients with liver cirrhosis Time: From illness onset of COVID-19 to death from liver-related cause, up to 365 daysDescription: Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis
Measure: Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis Time: From hospital admission to death, up to 365 daysDescription: Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis
Measure: Baseline characteristics of COVID-19 patients with liver cirrhosis Time: 1 DayThis study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
Description: Changes in strength will be measured using a five repetition maximum test (5RM)
Measure: Change in Strength Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Measure: Change in Cardiorespiratory Fitness Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory volume in 1 second (FEV1) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced vital capacity (FVC) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in FEV1/FVC ratio (FEV1%) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory flow (FEF) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S
Measure: Sweat chloride level Time: Four assessment points throughout the study: baseline and after each 8-week interventionProton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections. However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia. Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported. Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis. Therefore, generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding. The STOPPIT trial is the first prospective, randomized, controlled, double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy. Importantly, patients with an evidence-based indication for PPI therapy are excluded from the trial. All study participants (n=476) stop their previous PPI treatment and are then randomized (1:1) to receive either placebo (intervention group) or esomeprazole 20mg/day (control group) for 360 days. The primary hypothesis anticipates a delay of re-hospitalisation and/or death (composite endpoint) in patients who discontinue PPI treatment as compared to patients who continue PPI therapy. Secondary objectives include the assessment of mortality, re-hospitalisation rates, infection rates, rate of acute hepatic decompensation and ACLF, as well as rates of upper and lower gastrointestinal bleeding events in both groups. Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment.
Description: Infection rates by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus-infection, Sars-CoV-2-infection)
Measure: Infection rates differentiated by site Time: 360 days after randomizationDescription: The gut microbiota composition will be analyzed by PCR
Measure: Changes of intestinal microbiota between baseline and day 90 Time: 90 days after randomizationImpacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),
Measure: Cancellation or postponement of consultations by the health professional or patient, Time: Up to 6 monthsDescription: Number of consultations cancelled by the teleconsultation/replacement patient,
Measure: Patient cancellation of teleconsultations/telecare replacement, Time: Up to 6 monthsDescription: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)
Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled), Time: Up to 6 monthsDescription: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).
Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration). Time: Up to 6 monthsDescription: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)
Measure: The reduction of each of the elements of care provision and health care utilization: Time: Up to 6 monthsDescription: Intravenous instead of intravenous administration
Measure: The change of modality of administration of antibiotic cures Time: Up to 6 monthsDescription: Questionnaire about taking or not taking treatment during confinement
Measure: Compliance Time: Up to 6 monthsDescription: Scale 0-21
Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well) Time: Up to 6 monthsDescription: A questionnaire on the presence or absence of toxic consumption
Measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown Time: Up to 6 monthsDescription: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)
Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19 Time: Up to 6 monthsDescription: Role of social inequalities in the consequences of containment assessed by qualitative methods
Measure: Assessing the role of social inequalities in the consequences of lockdown Time: Up to 6 monthsDescription: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis
Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis. Time: Up to 6 months