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50 active trials for Respiratory Disease

Yorkshire Enhanced Stop Smoking Study

Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.

Start: July 2017

Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients

Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.

Start: October 2020

Ventilation Imbalances in Mild to Moderate Chronic Obstructive Pulmonary Disease

The Investigators plan a single center study to get preliminary data to answer a number of fundamental questions directly related to management of COPD. The research will determine whether ventilation heterogeneity and distribution of ventilation inform, determine, assist or drive the: 1) status or clinical course in patients with COPD, 2) understanding of factors associated with activities of daily living and quality of life in patients , 3) risk of exacerbation or hospitalization in those with COPD, and 4) predictors of therapeutic pathway or treatment regime.

Start: May 2021

Infant Forced Oscillations Technique (iFOT)

The aim of this study is the implementation of Forced Oscillations Technique (FOT) in newborns and small infants using a novel commercially available device. The objective is to assess the feasibility of the method, provide normative data for the first months of life and describe short- and long-term changes in neonatal respiratory disorders. The study population will consist of term and preterm newborns admitted to the Neonatal Intensive Care Unit (NICU) or the Well-Baby Nursery of the University Hospital of Patras, Greece. It is estimated that 200 full-term and 150 preterm newborns will be enrolled during a period of 36 months (March 2021 - September 2022). Measurements will be performed using the TremoFlo N-100 via a face mask, with the infant in the supine position during natural sleep. At least 3 technically acceptable measurements (duration 10s each) will be obtained, as follows: Healthy full-term neonates: postnatal days 1, 2, 3 and at discharge Preterm neonates: NICU admission, postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge All participants will be also measured at the age of 3, 6 and 12 months.

Start: April 2021

AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion

The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion. Who is it for? You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion. Study details Consenting participants will be randomised to one of two treatment arms: Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be instructed to undergo a daily drainage regimen for 14 days at home. Arm 2: Surgical pleurodesis. Participants under a key-hole surgery to remove fluid and facilitate lung re-expansion. Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge. It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.

Start: May 2018

Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: Change care delivery Improve health outcomes Improve the experiences of young adult transition to adult care

Start: February 2018

Post COVID19 Functional and Cognitive Assessments

The main objective of the proposed study is to evaluate the impact of coronavirus (2019-nCoV), hereafter COVID -19, on patients' loss of functional capacity after completion of hospital treatment. Specifically, the research will focus on examining changes in musculoskeletal, cardiovascular, and respiratory function, as well as motor control. In addition, we aim to evaluate rehabilitation treatments after recovery from COVID -19 and consider additional preventive measures based on previous experience.

Start: January 2021

The Study Will Evaluate the Use of Nintedanib in Slowing Lung Fibrosis in Patients With Pulmonary Infiltrates Related to COVID-19

This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.

Start: November 2020

Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients

This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure. Primary Objective To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients. Secondary Objectives To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases. To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure. To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases. Exploratory Objectives To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site. To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.

Start: January 2021

UltraSound for Accurate Decisions in Chest PhysioTherapy

Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an analysis of blood gasses and chest imaging to determine the indication for chest physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management. Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate treatments. No study has evaluated the impact of LUS on clinical decisions in chest physiotherapy in ICU patients. Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU. Method: The physiotherapist carries out a clinical examination and analyses the complementary tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination, he will put forward one or several hypotheses concerning the respiratory deficiency and will confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is indicated, the physiotherapist will specify the protocol. A lung and diaphragm US will be done following the evaluation of the clinical physiotherapist, and will make it possible to answer the question: are the results of the lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol according to the results of the US-scan. The modification of the clinical decision will be assessed with the Net Reclassification Index (NRI). Expected results: We expect that decisions for chest physiotherapy will be modified by LUS. The expected benefit for patients is therefore that they will be given a chest physiotherapy protocol that is better suited to the type of respiratory deficiency they are suffering from.

Start: May 2017

SWISH Trial (Strategies for Weaning Infants on Supportive High Flow)

Bronchiolitis is a common type of chest infection that tends to affect babies and young children under a year old. In older children and adults, the same viruses that cause bronchiolitis lead to the 'common cold'. The symptoms of bronchiolitis are like a common cold and include a blocked or runny nose, a cough and a mildly raised temperature. Bronchiolitis affects the bronchioles which are the smaller breathing tubes in the lungs. They produce more mucus than usual and become swollen, leading to a cough and a runny nose. In more severe cases, the tubes become clogged up with mucus which causes breathing problems. In some babies, the breathing problems may present as breathing fast, with in-drawing of the muscles around the rib cage, and in rare cases, very young babies with bronchiolitis may stop breathing for brief periods ('apnoea'). The illness usually starts with a mild runny nose or cough, gets worse over three to five days or so, and then slowly gets better, usually lasting about 10 to 14 days in total. Around 2 in 100 infants with bronchiolitis will need to spend some time in hospital during the course of their illness. This is usually for one of two reasons: they need oxygen treatment to keep their oxygen saturations within acceptable levels or they cannot manage to feed from the breast or a bottle because of a blocked nose or difficulty breathing. Here at the Children's Hospital for Wales we are using 'High flow' to deliver oxygen. This is a relatively new concept on the general paediatric wards, and more established in a setting such as High Dependency Unit (HDU). However, we have been using it successfully on the wards for the last 3 years. High flow device delivering a mixture of oxygen and air at high flow to help open the child's airways so that their lungs can add oxygen to their blood. It is given through a set of prongs (short plastic tubes) inserted just inside the nostrils. Research has shown that the early use of high flow can reduce the chances of the child needing escalation of care to a high dependency unit or paediatric intensive care unit. The investigators are interested in studying the process of weaning high flow support once the child is over the worst of their illness. This will enable the investigators to use the most effective method of weaning babies from their high flow, and ready for discharge. This has the potential to reduce the number of hours spent in hospital for babies and their parents or guardians.

Start: October 2021

A Study of Patients With Chronic Disease

TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

Start: February 2020

COVID-19 Longitudinal Biomarkers in Lung Injury

Profile known and novel biomarkers in blood in COVID19 patients to characterize the host response to SARS-CoV-2 over time and in response to treatment. The investigators aim to: Better understand the disease. The investigators will achieve this by characterizing the biology of COVID-19 infection and the pathophysiology of the host response using clinical data together with cellular and molecular measurements over the course of the disease. This will allow better insights for the discovery and development of novel therapeutics. Understand why different patients have different phenotypes and disease presentations over time. The investigators will achieve this by analyzing for patient subgroups. This will allow targeted patient stratification and better matching of resources. Understand how patients are responding to the different medications being tested in clinical trials. The investigators will achieve that by co-enrolling with therapeutic trials. This will allow an understanding of the biological effects of these interventions. Study Design: Observational adaptive study of a translational nature, combining clinical data and basic science investigations in blood samples in the same patients, longitudinally, with serial interim analyses. Primary outcomes: 90 day ICU mortality. Secondary outcomes: measures of ICU utilization and disease severity, and 90 day in-hospital mortality. The study ends after 3 months from admission to the ICU, hospital discharge or death. Location: St. Michael's Hospital (Unity Health Toronto), an academic center in downtown Toronto affiliated with the University of Toronto. The investigators will collect: A) Detailed clinical data including investigations, mechanical ventilation and cardiovascular parameters. B) Blood samples for state-of-the-art multi-omics biomarker discovery and development: cytokines, anti-COVID19 antibodies, autoimmune serology, metabolomics, transcriptomics, epigenomics, deep immune phenotyping, viral loads. For those patients who die with COVID19 The investigators will perform bedside post-mortem biopsies of lung, heart, kidney and muscle. Sampling times: From admission to the maximal severity phase through convalescence, in order to capture the evolution and dynamics of the disease and the recovery process: days 0,1, 3, 5, 7, 10, 15 and 22, and then every 2 weeks until the end of the study (3 months from admission to the ICU, hospital discharge or death).

Start: March 2020

Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

Fiberoptic bronchoscopy (FOB) is widely used as a diagnostic or therapeutic procedure in intensive care units. Patients with ARDS or COVID-19 disease often undergoes to these procedures. However, intensive care patients might suffer from serious side effects such as prolonged oxygen desaturation and adverse change in lung compliance and resistance. This study aims to evaluate these changes and determine their impact on patient stability.

Start: September 2020

Effects of Integrative Medicine on Infectious Respiratory Diseases Including COVID-19

The outbreak of the novel coronavirus SARS-CoV-2 caused a health emergency of international proportions when it was declared by the World Health Organization (WHO) in January 2020. Since then, the virus has spread internationally and the WHO has classified the outbreak as a pandemic. In the context of the increasing reporting of this pandemic and the increasing governmental measures to limit or slow down the spread of SARS-CoV-2 by all means, there is so far little scientific evidence for the effects of a healthy lifestyle on the disease. The aim of this study is to compare the potential of different, possibly protective lifestyles using the example of the COVID-19 pandemic. We will conduct an online survey with 3.000 participants using mobile website technology.

Start: January 2021

Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate

Collect data from the CardiacSense1's sensors and Capnograph, for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) in patients while at hospital

Start: June 2020

Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

Assessment of lung function requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced oscillation technique (FOT) is increasingly being used in clinical settings to evaluate lung function noninvasively by measuring the mechanical input impedance of the respiratory system. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. Recently a new methodology (within breath analysis) has emerged to evaluate changes that occur in the impedance during the breathing activity. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters. The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.

Start: October 2018

Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe

This research study will evaluate the difference in effectiveness of nasal suction between two different suction devices (NoseFrida and bulb syringe) in infants that have bronchiolitis. Bronchiolitis (a virus infection that goes into the lungs, which subsequently causes difficulty breathing, difficulty sleeping, and difficulty eating and drinking in children) is a common infection in young children. After parents or guardians (caregivers) provide informed consent for their child, researchers will review the child's medical record for information regarding their history of respiratory distress. Caregivers will be asked to use one of the suction devices (the device received will be dependent on what week the child presents present to the Emergency Center) upon return home. The device should be used to clear nasal secretions as needed throughout the week following discharge from the Emergency Center. Caregivers will monitor how well their baby is breathing, eating/drinking, sleeping and how many times the baby has been seen by a medical provider in the 7 days post discharge from the Emergency Center. At 7 days after discharge from the Emergency Center, caregivers will complete a survey asking questions about how their baby has been doing over the past week. This completes study involvement.

Start: November 2020

Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology

The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patient's chest, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the care of the community respiratory team. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions: What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device? The investigators will also consider: Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores). These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals.

Start: February 2021

Children's Health in London and Luton (CHILL)

Investigating the impact of London's Ultra Low Emission Zone on children's respiratory health

Start: March 2018