View clinical trials related to Respiratory Tract Diseases.
Filter by:Aim is to to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of respiratory disease in the study's clinical setting compared to a clinical adjudication committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for respiratory disease diagnosis in an emergency department. Eligible subjects will be consented/enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF). The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0 diagnoses. Additional medical information will be collected from the treating team, from the subject and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a clinical adjudication committee (CAC) will determine the final clinical diagnosis using the disease case definitions, eCRF data and the subject's medical record. Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed. The blinded ResAppDx v2.0 diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0 diagnoses compared to agreement with the CAC's final clinical diagnoses.
Aim of study is to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of paediatric respiratory disease in the study's clinical setting compared to a Clinical Adjudication Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for paediatric respiratory disease diagnosis in an emergency department. Eligible subjects/parents will be assented/consented, enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF).The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0diagnoses. Additional medical information will be collected from the treating team, from the subject/parent and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a CAC will determine the final clinical diagnosis for each enrolled subject using the disease case definitions, eCRF data, the subject's medical record and cough sound recordings.Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost and time of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed.The blinded ResAppDx v2.0diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0diagnoses compared to agreement with the CAC's final clinical diagnoses for this cohort.
This research was planned as a randomized controlled experimental type to determine the effect of using a projector caleidoscope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. The data of the research will be collected using the following data collection tools; Child Information Form and Fear Rating Scale
The Mucopolysaccharidoses (MPS) are a family of genetic metabolic disorders, caused by specific enzyme deficiencies which result in accumulation of partially degraded glycosaminoglycans (GAGs) within various tissues. As GAGs are common in the body a number of different organ systems can be affected. Involvement of the upper and lower respiratory tract in MPS Type II results in significant airway compromise, with progressive airway obstruction being responsible for a significant proportion of the morbidity and mortality associated with this condition. Hearing loss is a universal finding in MPS, with a third of patients suffering with severe profound hearing loss. There is an unmet need for strong clinical evidence to guide treatment of head, neck and respiratory disease in MPS disorders. A Core Outcome Set (COS) describes the minimum outcome data that should be measured in a clinical study for a particular condition. The lack of an agreed COS for MPS II in general, and specifically head, neck and respiratory disease, makes comparison between studies difficult. There is also a lack of information detailing patient and parent perspectives on the MPS disorders. The ideal COS for head, neck and respiratory disease associated with MPS II would combine both patient/parent and clinician opinion and could be used in the design of all subsequent clinical studies. Following literature review the investigators have created a list of outcomes previously reported for qualitative and quantitative studies investigating head, neck and respiratory disease in MPS II. For the proposed research the investigators will seek opinions of patients, parents, clinicians and scientists to rate these outcomes via the Delphi method. Outcomes scored highest by patients, parents, clinicians and scientists will form a COS for head, neck and respiratory disease in MPS II. The development of a COS can help limit variability outcomes in studies investigating different interventions in MPS II.
Respiratory diseases are very common and are the third leading cause of death in England. As such, there is strong interest in understanding how respiratory disease occurs. This study intends to understand the changes that occur within diseased/injured lungs obtained from humans. The end goal of this will be to create new drugs to help treat these disorders. Diseased lungs will be obtained from patients receiving a lung transplant. Lungs will either be placed onto a heart-lung machine, or surgically cut in order to create a model of the lung that can be used experimentally in the laboratory. Using a heart-lung machine, lungs can be maintained outside of the human body for a maximum of 12 hours, allowing the direct assessment of the organ. Using this procedure, we aim to understand the processes that occur within a disease, as well as during repair. Using the model of the lung, we will look at how the body's immune system interacts within a diseased lung.
The purpose of this clinical study is to determine if a learning effect exists when the 5STS is assessed remotely via videoconference in patients with COPD.
Pulmonary Arterial Hypertension is a progressive disease that has no cure. Patients die young and are limited in their daily activity. Current treatments only treat the symptoms of the disease rather than the underlying cause. At least 1 in 5 patients has a change in a gene called the bone morphogenetic type 2 protein (or BMPR2). Extensive evidence supports the concept of addressing the reduced levels of the BMPR2 protein to reverse disease. Through work already undertaken by this group, two potential therapies which increase BMPR2 have been identified for use in a future randomised control trial. In order for a clinical trial to be informative we need an accurate way of measuring the protein or the effects of the protein (known as a biomarker). This study will use blood samples taken from 17 patients and 30 healthy participants over various time-points (2-5 visits over 5 weeks for healthy controls; 2 visits, approximately four months apart for patients). Laboratory work will help identify the best biomarkers for subsequent therapy studies. By defining the best biomarkers we can speed up the drug development in this rare disease.
The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.
In August 2021, the Italian Ministry of Health published the Ministerial Decree to define the "Criteria for the appropriateness concerning the access to hospital rehabilitation admission" (in neurological, respiratory, cardiological, and orthopedic Units), classifying patients by complexity, the severity of disability and the number of ICD-9 discharge codes. The Appropriateness Decree adopted some fundamental criteria used in the United Kingdom for over 10 years (2009) where the Ministry of Health defined 3 levels of specialized rehabilitation based on the different complexity of the patient's needs. Among the scales, the Rehabilitation Complexity Scale (RCS) has been proposed by the British Society of Rehabilitation Medicine (BSRM), clearly oriented to patients with motor disabilities (neurological and orthopedic), of which the RCS-E (i.e. Extended version) is the more up to date. The Italian Ministry of Health has proposed the application of the RCS scale as a tool for measuring rehabilitation complexity based on the intensity and level of skills required in terms of nursing, medical and therapeutic care. In this Clinical Study the Investigators intend to 1. test the application of the new RCS scale to rehabilitation admissions in 16 Italian Pulmonary Rehabilitation Units 2. correlate this scale to the most universally used clinical and functional measures evaluated in the respiratory field 3. investigate the responsiveness of the RCS scale at the end of rehabilitation 4. promote an audit to revise the clinical and rehabilitation conditions -described by items of the RCS-E- to get a specific RCS referable to respiratory patients with MDC4.
This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method