Machine Learning-based Models in Prediction of DVT and PTE in AECOPD Patients
Machine LearningChronic Obstructive Pulmonary Disease4 moreChronic Obstructive Pulmonary Disease (COPD) is a common respiratory system disease characterized by persistent respiratory symptoms and irreversible airflow restriction, which seriously endangers people's health. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) refers to individuals who experience continuous deterioration beyond their daily condition and need to change their routine medication. AECOPD is usually caused by viruses and bacteria, and patients require hospitalization, which brings a huge economic burden to society. AECOPD patients often have limited activities. Because long-term chronic hypoxia causes venous blood stasis, siltation causes secondary red blood cell increase, and blood hypercoagulability, AECOPD patients have a high risk of pulmonary embolism (PE). Pulmonary Thrombo Embolism (PTE) refers to a disease caused by blockage of the pulmonary artery or its branches caused by a thrombus from the venous system or right heart. AECOPD patients experience elevated hemoglobin levels and increased blood viscosity due to long-term hypoxia. At the same time, such patients have decreased activity, venous congestion, and are prone to thrombosis. After the thrombus falls off, it can travel up the vein, causing PTE to occur in the right heart PTE is often secondary to low deep vein thrombosis (DVT). About 70% of patients were diagnosed as deep vein thrombosis in lower limb color ultrasound examination. SteinPD conducted a survey on COPD patients and general patients from multiple hospitals. The results showed that by comparing adult COPD patients with non COPD patients, the relative risk of DVT was 1.30, providing evidence for AECOPD being more likely to combine with PTE AECOPD patients with PTE have similarities in their clinical manifestations. It is difficult to distinguish between the two based solely on symptoms, such as cough, increased sputum production, increased shortness of breath, and difficulty breathing. They lack specificity and are difficult to distinguish between the two based solely on symptoms, which can easily lead to missed diagnosis. CT pulmonary angiography (CTPA) is the gold standard for the diagnosis of PTE, but due to the high cost of testing and high equipment prices, its popularity in grassroots hospitals is not high. Therefore, analyzing the risk factors of AECOPD patients complicated with PTE is of great significance for early identification of PTE. At present, although there are reports on the risk factors for concurrent PTE in AECOPD patients, there is no specific predictive model for predicting PTE in AECOPD patients. In clinical practice, risk assessment tools such as the Caprini risk assessment model and the modified Geneva scale are commonly used for VTE, while the Wells score is the PTE diagnostic likelihood score. The evaluation indicators of these tools are mostly clinical symptoms, and laboratory indicators are less involved, It is difficult to comprehensively reflect the patient's condition, so the specificity of AECOPD patients with PTE is not strong. The column chart model established in this study presents a visual prediction model, which is convenient for clinical use and has positive help for the early detection of AECOPD patients with PTE. In addition, medical staff can present the calculation results of the column chart model to patients, making it easier for patients to understand. It helps improve the early identification and treatment of AECOPD combined with PTE patients, thereby improving prognosis.
Real-world, 52-week Prospective Study to Capture the Reasons for Switch to Triple Combination Therapy,...
Pulmonary DiseaseChronic Obstructive (COPD)Chronic obstructive pulmonary disease (COPD) is a debilitating and progressive respiratory condition characterized by irreversible airflow limitation. The overall 5-year survival for COPD patients is 56-92%, depending on disease severity. Considering the recent introduction of the Budesonide, Glycopyrronium bromide and Formoterol fumarate Metered-Dose Inhaler (BGF MDI) in COPD therapeutic arsenal as well as the increasingly important role of real-world (RW) data in health care decisions, as it bridges gaps not addressed by randomized clinical trials, there is a need for RW evidence studies that can serve as inputs for Health Technology Assessment (HTA) submissions. In view of this need, this study is designed to generate RW evidence on the clinical and patient-reported outcomes of treatment with BGF MDI over a 52-week treatment period in routine care settings in Greece as well as to shed light on the reasons for switching from dual to triple therapy with BGF MDI, aiming at further characterizing the multifactorial aspects of inadequate COPD management that lead physicians to step-up treatment. The study is mainly descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis. This is a single-country, non-interventional, multicenter, 52-week prospective cohort study, mainly based on primary data collection, which will include adult patients with moderate to severe COPD newly prescribed maintenance treatment with BGF MDI in routine care settings of Greece. This study design has been selected on the basis that such studies essentially, through collecting data generated in the course of routine clinical care about management practices and their outcomes from both the physician and patient perspective, help to bridge the knowledge gap between clinical research in controlled randomized settings and daily clinical practice. In line with the purely observational and non-interventional nature of the study, no changes to the current standard of care will be required and all aspects of treatment and clinical management of patients will be in accordance with local clinical practice and at the discretion of the participating physicians. The conduct of this study will adhere to the applicable national regulatory requirements governing the conduct of such type of clinical research. In addition, the study has been designed and will be conducted and reported in accordance with the ethical principles laid down in the Declaration of Helsinki, the Guidelines for Good Pharmacoepidemiology Practice (GPP) of the International Society for Pharmacoepidemiology, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines where applicable, the European Union (EU) General Data Protection Regulation (GDPR), and the local rules and regulations. Patients will have been prescribed BGF MDI (Trixeo Aerosphere™) prior to informed consent (IC) obtainment and will be treated according to the local prescribing information (Summary of Product Characteristics [SmPC]) of the study medication and routine medical practice in terms of visit frequency and type of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of BGF MDI is clearly separated from the physician's decision to include the patient in the current study. In addition, every medical decision including the course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation according to the product's SmPC. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 12, 24, 36, and 52-week data collection timepoints post-index (i.e., after BGF MDI treatment initiation) with an allowable time window of ±2 weeks for each data collection timepoint. Data collection at the aforementioned timepoints will be performed in the context of on-site routine visits at the private practices/hospital clinics. In addition, a telephone contact will take place at 4 (±1) weeks post-index for the sole purpose of administering COPD Assessment Test (CAT) by phone interview with the patient. Any visits/contacts occurring at other times not pre-planned in the context of the study will not be captured for the purposes of this study, except for safety-related information, exacerbation data, information on BGF MDI and concomitant COPD-related treatments, that will be collected on a continuous basis. Data collection at all indicated timepoints will be performed in the context of on-site routine visits at the private practices/hospital clinics. There are no dose regimens or diagnostic procedures pre-defined within this study plan. Participation in this observational, real-life study and its documentation procedure will not affect the routine treatment situation in any way.
Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease
Chronic Lung Disease of PrematurityRespiratory Distress Syndrome in Premature Infant1 moreThe purpose of this study is to identify the safest dose of recombinant surfactant protein D (drug name: rfhSP-D) that can be administered to preterm infants born at less than 28 weeks gestation, and to help identify whether this can prevent the development of neonatal chronic lung disease.
Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Pulmonary HypertensionChronic Obstructive Pulmonary DiseaseERASE PH-COPD is a randomized double-blind study, with 2 parallel groups. Patients with severe pulmonary hypertension due to chronic obstructive pulmonary disease, will be randomly assigned to receive Tadalafil orally or placebo.
Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease
Non-Tuberculous Mycobacterial PneumoniaNon-tuberculous mycobacterial (NTM) pulmonary disease (PD) is an emerging condition with heterogeneous manifestations from both the microbiological and the clinical point of view. Diagnostic and therapeutic guidelines are available but there are still unmet patients' and physicians' needs, including the exams to perform in the nutritional evaluation and intervention to improve health-related QoL and to control gastrointestinal side-effects during antimicrobial therapy, particularly in those with low body mass index and history of weight loss.
Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation
Lung DiseasesThis study aims to evaluate the efficacy and ease of placement of two different endobronchial blockers(Arndt and Tappa blocker) for pediatric patients undergoing thoracotomy. Time from laryngoscopy to successful insertion of the blocker by an experienced anaesthetist will be recorded and the difficulty of placement of the blocker will be assesed. We plan to evaluate the lung collapse and also observe the effect of two different bronchial blockers on patients' ventilation and oxygenation and adverse events such as desaturation, failed one lung ventilation.Our primary outcome is the time from laryngoscopy to successful insertion of the bronchial blocker by an experienced anaesthetist. Our secondary outcomes are effects of two different bronchial blockers on lung isolation score, ease of placement of the bronchial blocker, mechanical ventilation parameters (tidal volume, respiratory rate, peak airway pressure, plateau pressure, compliance), intraoperative blood gas analysis (paO2, pCO2, saO2, lac), frequency of malposition after successful blocker placement, surgical exposure and complications.
Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post...
Mixed Anxiety DepressionDiabetes Mellitus4 moreThe health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers. The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue. The concentrated interdisciplinary rehabilitation is characterised by three phases; Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below) Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living The concentrated intervention: The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely: Initiate treatment when the patient is ready for change Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices"). Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others. Use long sessions to ensure that they face a broad range of potential micro-choices Work side-by side with others going through an analogous pattern of change Prepare them for taking responsibility for integrating the change into every-day living Main outcomes will be Completion rates Patient satisfaction Changes to perception of illness Patient activation Secondary outcomes will be Level of functioning Qualitative description of participants' experiences
Inspiratory Muscle Training Immediately After Lung Transplantation
Lung TransplantationChronic Lung Disease2 moreFollowing lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life. Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease. The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.
Trikafta Exercise Study in Cystic Fibrosis
Cystic FibrosisLung DiseasesShortness of breath (dyspnea) during exercise is a major source of distress and is a commonly reported symptom in patients with cystic fibrosis (CF). A recent drug treatment option known as Trikafta, which contains elexacaftor, tezacaftor, and ivacaftor, may be used in patients with CF to help improve lung health. However, the effects of this combination therapy on dyspnea and exercise performance, a known predictor of survival in CF, are not clear. The investigators aim to understand the effects of Trikafta on these symptoms and to gain new insight into the potential health improvements in CF from using this treatment option.
Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome...
Nontuberculous Mycobacterial Lung DiseaseMycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome