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NCT06156462
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.
NCT07184372
The sequelae that occur in post-COVID-19 patients are multiple and, at a therapeutic level, these represent a new challenge within the general context of the pandemic that the world is suffering. The virus has managed to end thousands of lives today and many other cases are being charged as directly responsible for a multiplicity of multisystem damages that need to be diagnosed and treated. Among the most relevant, are those that can affect to respiratory levels in patients without previous pahologies, and in patients at risk who already had a pathology prior to infection. On the other hand, signs and symptoms have been observed characteristic in the organ systems described above in post-contagion patients, directly associated with sequelae SARV-CoV2. The radiofrequency (RF) of electromagnetic waves represents a technology of proven efficacy and safety in multiple fields of both human and veterinary medicine. These include neurological pathologies, respiratory disease and very especially those that affect the locomotor system. In therapeutics there are different RF modalities depending on the modality, polarity, type of signal and frequency, which in turn translate into different therapeutic profiles, clinical indications, efficacy and safety. Among the RF technologies most used today and that have a greater scientific background, is the one known as Resistive Capacitive Monopolar RadioFrequency at 448 kHz (INDIBA®) (RFMCR). This study aims to assess the efficacy and safety of RFMCR in the treatment of respiratory sequelae in patients presenting this type of pathologies that appear after contagion by COVID-19. Through this non-invasive technique, the investigators want to show that RF can help the physical rehabilitation of these patients through metabolic stimulation, increased vascularization and oxygenation of directly affected tissues, effects of deep hyperthermia generated by the interaction of the current with the treated biological substrate, as well as the activationof tissue regeneration, the result of subthermal action. It is thus intended to improve signs such as lung capacity, dyspnea, neuropathies and global muscle capacity, which are essential for the recovery of the post-COVID-19 patients. The hypothesis of this study is that current post-COVID-19 treatments can be significantly improved in order to prevent complications and ensure the patients' well-being.
NCT06495021
This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.
NCT04326114
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
NCT06921278
The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews
NCT04649736
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.
NCT03230968
Background. Mexico is lacking guidelines that provide an integral approach for the prevention and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a "Practical Approach to Lung Health" (PAL) using generic guidelines to be used in primary health care settings for diagnosis and treatment of respiratory diseases. These guidelines were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,. Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013 (phase 1), investigators recruited consenting subjects older than 15 years of age seeking medical care in primary care centers in Orizaba, Veracruz. Researchers investigated sociodemographic, epidemiological and clinical information before consultation. On patients who had been diagnosed with respiratory disease by a physician, researchers investigated prescribed treatment on leaving the physician´s office. A month later conducted a home visit to investigate clinical outcome. During 09/2014 we trained doctors from the participating health centers in "AIRE" guidelines. From 10/2014 to 03/2015 (phase 2) researchers again surveyed all consenting subjects older than 15 years of age who received health services in the same health centers following the same procedures as in phase 1.
NCT04851808
Chronic Respiratory Disease (CRD), particularly asthma and chronic obstructive pulmonary disorders (COPD) are leading causes of mortality and reduced quality of life due to its wide-reported association with other multi-morbidities.There is limited knowledge on the burden of CRD in the rural communities in Bangladesh due to poor awareness on the impact of CRD on quality of life and unavailability of diagnostic facilities due to weaker primary healthcare settings. The study aims to estimate the CRD burden in Bangladesh in a large representative population to draw the attention of policy makers to the creation of social awareness and improvement of primary healthcare infrastructure for respiratory disease in Bangladesh. The study is a prospective observational one in nature. The study will be implemented in Mirzapur, a rural sub-district of Tangail district in Bangladesh within the period of February to May 2021. A total of 981 participants will be enrolled from the study. Verbal consent will be taken initially. Participants who are assessed to be COVID-19 negative will be invited for a visit to the mobile clinic following national health guidelines to perform the spirometry. The study team will provide an information sheet (written in local language) that describes the study aim and objectives with potential risk benefits to the participants. All participants will be enrolled through written consent and satisfactory response to the patient information sheet. The Research Assistant (RA) will collect the relevant metadata such as demographics, information on risk factors, screening questionnaires relevant to asthma and COPD, reported health status and symptoms related to CRD etc. from the participant after obtaining the written consent. Data quality will be ensured by the Field Research Supervisor through checking all the collected information. The enrolled participants will undergo spirometry for the evaluation of their lung function. Spirometry will be collected by trained personnel and will be quality checked by an expert panel at CHRF. Repeated collection will take place in the event if the test results do not pass quality checking. Participant will also be invited to the study clinic within the next 10 days after assessment for any further clinical assessment that is deemed necessary by the study physician. The collected data and spirometry reports will be reviewed to evaluate the CRD patient in terms of their disease. The study will analyse the rate of CRD burden stratified by age, sex, and income group. The productivity loss will be measured in terms of work hours lost due to CRDs.
NCT06070831
Background: Respiratory health problems are one of the main causes of morbidity and mortality in adult people with acquired brain injury (ABI). The influence of respiratory muscle training has not yet been studied in this population group. The objective of the study was to evaluate and compare the efficacy of two protocols with respiratory muscle training, inspiratory muscle training vs expiratory muscle training, to improve respiratory strength and pulmonary function in adults with CP. Methods: The study is a controlled, randomised, double-blind trial and with allocation concealment. 26 ABI patients will be recruited and randomly distributed in the inspiratory muscle training group (IMT) and the expiratory muscle training group (EMT). Over an 8-week period an IMT or EMT protocol was followed 5 days/week, 5 series of 1-minute with 1-minute rest between them. IMT trained with a load of 50% of the maximum inspiratory pressure (MIP) and EMT with 50% of the maximum expiratory pressure (MEP). Respiratory strength and pulmonary function were evaluated.
NCT03238209
To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and RMSsc.
NCT03595488
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score \> 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.
NCT05648227
A retrospective study to evaluate the diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.
NCT04681430
This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.
NCT05820776
Pulmonary rehabilitation is a program that helps people with lung disease improve their function. It uses exercise, education, and self-management strategies to improve physical ability and quality of life. Because some people are unable to visit West Park Healthcare Centre, we established a remote supervised pulmonary rehabilitation program that patients can access via an electronic device (computer, tablet or smart phone). Regular quality assurance is necessary to ensure that the program is effective. We plan to collect and summarize the program's results. The benefit of doing so is that it allows us to make any changes or improvements that may help patients with chronic respiratory conditions.
NCT05881590
Pulmonary rehabilitation is an exercise and education programme that helps improve breathlessness and quality of life for people living with lung and breathing problems. It improves exercise levels and breathlessness and is a recommended treatment for people with lung diseases and symptoms. Standard pulmonary rehabilitation programmes involve individuals attending group classes at hospitals or community centres, twice a week for 8 weeks. These classes are supervised by physiotherapists. At the moment, there are long waiting times for pulmonary rehabilitation in the NHS. Some patients may prefer more pulmonary rehabilitation based in their own home. This might be because they find it difficult to travel to classes. Some would like to do more home pulmonary rehabilitation in between supervised classes or continue pulmonary rehabilitation after the 8-week supervised programme. The blending between supervised classes and home pulmonary rehabilitation is known as HYBRID PULMONARY REHABILITATION. Hybrid pulmonary rehabilitation is not being provided routinely in the NHS, but the NHS would like to see it used more as it might help reduce waiting times and give patients more choice on how to access pulmonary rehabilitation. The study will assess the feasibility of a larger study to provide strong evidence on patients' uptake and adherence to the hybrid programme, and the impact on patients' health outcomes and service delivery. The investigators will also look at what measures would be best to use in a larger study. The study will recruit up to 100 patients. These individuals will be aged 18 years or older, have respiratory disease and a referral for pulmonary rehabilitation. Individuals with reasons why they cannot exercise will be excluded. Participants will be provided with an application (App) that can be installed on a mobile phone. This App is called Active+me REMOTE and is made by a company called Aseptika Ltd (www.activ8rlives.com). Active+me REMOTE provides live online, video exercise classes; pre-recorded exercise classes; a walking programme; educational talks; and a care plan personalised for the user. Data will be collected at the beginning and end of the hybrid pulmonary rehabilitation programme and will include routinely collected data as part of usual care. Additional data will be collected via the App and trial surveys. The investigators will ask staff and patients about the experiences of the new way of delivering rehabilitation and explore how cost effective it is.
NCT06470932
This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.
NCT04693091
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: 1. What is the feasibility of the Senti data-capture device? 2. Is this device usable in clinical practice? 3. What are the requirements to train patients to use the device? The investigators will also consider: 4. Does the device function technically and practically, in real-world clinical scenarios? 5. 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.
NCT07419555
Currently, it remains unclear how to manage serial lung function measurements in a clinical setting. The investigators aimed to tackle this problem by developing a machine learning (ML) model that can accurately predict population and individual lung function trajectories. These predictions would enable the investigators to identify positive or negative deviations, thereby revealing unexpected disease patterns. A prospective validation is needed that includes data on mortality, hospitalisations, emergency-room visits and patient-reported outcomes. Within this study, the goal is to validate the ML model with the data collected from this observational study.
NCT06726226
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary dysplasia, postnatal corticosteroids, ventilatory support, as well as nutritional aspect during NICU stay. Furthermore, it scrutinizes the incidence of chronic respiratory diseases stemming from these conditions, assessing their long-term impact on respiratory prognosis post-discharge. In addition to respiratory aspects, the research extends its focus to the growth and developmental outcomes of preterm infants. By synthesizing these multifaceted elements, the study aspires to enhance current treatments and preventative measures for respiratory conditions in preterm infants.
NCT00192439
\- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at \<2 years of age).