View clinical trials related to Respiratory Tract Diseases.
Filter by:Rationale: COPD is increasing in prevalence among people living with HIV/AIDS (PLWHA) as widespread use of ART has increased longevity in this population. In rural Ugandan ART clinics, we report COPD prevalence of 6.22%. Currently, it's not fully known what drives chronic lung inflammation in PLWHA population despite being virologically suppressed on ART. There is need to explore factors driving chronic airway inflammation among PLWHA. Airway microbiome has been implicated in the pathogenesis of COPD. Preliminary analysis from our study revealed that, specific microbes were significantly enriched in PLWHA with COPD with more lung bacteria impacted by HIV than COPD. These findings suggest that HIV-associated changes in unique airway microbial genera may be driving COPD among PLWHA in our cohort. Currently, we don't know how such genera drive chronic airway inflammation. Study objectives: In this study, we will: (1) establish a relationship between airway microbiome and Th17/Treg cellular phenotypes among HIV-infected individuals with COPD; (2) investigate bacterial-mediated Th17 upregulation of pro-inflammatory and pro-fibrotic genes among HIV individuals with COPD and (3) explore the role of bacterial outer membrane vesicles (OMVs) in mediating microbiome driven Th17 immune responses among HIV individuals. Methods: We will conduct a 2-year case-controlled study, leveraging on the established lung microbiome cohort in rural Nakaseke district of Uganda. We will recruit 80 HIV-infected individuals ≥35 years attending the ART clinic at Nakaseke General Hospital screened for COPD as well as 80 HIV-negative controls ≥35 years attending the pulmonary clinic at Nakaseke General Hospital screened for COPD. In both cases and controls, we will consider 40 stable COPD participants and 40 participants with no COPD. Recruited participants will undergo sputum induction protocol at our newly established negative pressure sputum induction facility at Nakaseke General Hospital following established standard operating procedures. Using induced sputum samples, we will (i) perform 16S sequencing and metagenomics analysis to determine airway bacterial communities, (ii) RNA sequencing and analysis to determine gene expression profiles, mass flow cytometry and analysis to profile immune cells in induced sputum of study participants as well as (iv) ELISA tests to compare OMV levels between participants.
The aim of our study is to compare the effectiveness of the supervized pulmonary telerehabilitation program and the cognitive telerehabilitation method, which includes pulmonary telerehabilitation methods, in patients with severe stage COPD who have difficulty exercising heavily. The effects of pulmonary and cognitive rehabilitation on dyspnea, muscle strength, functional capacity, quality of life, anxiety and depression levels in this patient group will be examined. The number of studies in the literature in which the pulmonary rehabilitation program was applied as telerehabilitation is insufficient. Considering that this patient group is not motivated and has difficulty in exercising, motor imagery and movement observation methods from cognitive rehabilitation methods may be alternative methods for these patients. Although these methods have been very popular in recent years in terms of researching and demonstrating their effectiveness in various patient groups in the literature, no study has been found in which the effects of these methods have been applied in pulmonary disease groups. This study aims to contribute to the serious gap in the literature on the application of pulmonary telerehabilitation and its effectiveness, and to be an original study by investigating the effectiveness of motor imagery and action observation, which are popular rehabilitation methods of recent years, in COPD patients in the pulmonary disease group for the first time.
Pre-hospital emergency health workers, who are on the front line among healthcare workers, are at greater risk in epidemic situations, as they are the first team to come into contact with the patient and are responsible for making necessary interventions by staying in close contact with the patient during the transfer process (1, 2). Health workers need to improve their knowledge, attitudes and skills during the pandemic process; on the other hand, they experience mental and communicative problems more strikingly. It is essential to increase the continuity of development, mental resilience, and communication of healthcare professionals(3). A randomised controlled study was planned to prepare a training program to improve pre-hospital emergency health workers' knowledge, attitudes, and skills about pandemic preparations and evaluate its effectiveness. The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians(EMT) (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and EMT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study. The work consisted of five stages: 1. Determining the needs in education, 2. Development of educational materials, 3. Making pre-training measurements, 4. Implementation of the training program, 5. Performing post-training measurements. As a result of the evaluation, the subjects that healthcare professionals need to train were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and attitudes of healthcare professionals to the patient in a simulated case and pandemic. The appropriate data collection form was chosen after the training program's content was determined. Before the intervention, the first measurements were taken via the COVID-19 knowledge, attitude, skills, and perceived barriers to infection control questionnaire, the communication competence scale, the psychological resilience scale, and the data collection form, including the simulated case approach. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method. After the training program, a post-test was applied after a four-week follow-up.
This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.
This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine). The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.
This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
The COVID-19 pandemic caused by SARS-CoV-2 since December 2019 has caused more than 210 million cases worldwide as of September 1, 2021. New Caledonia (NC) is an ultramarine French territory in the South Pacific so far relatively spared by this pandemic thanks to the establishment of a health lock. The vaccination campaign started locally on 20/01/2021 with the exclusive use of Pfizer's COMIRNATY mRNA vaccine. Vaccination is now offered to anyone over the age of 12. Vaccination against COVID-19 will be mandatory in New Caledonia as of October 31, 2021 for certain exposed populations and for the entire adult population as of December 31, 2021. Clinical trials of COVID-19 vaccines, including those of mRNA vaccines, have taken care to maintain ethnic diversity within their samples. Efficacy studies have not shown a significant difference in the efficacy of Pfizer COMIRNATY vaccine in white, black American, or Hispanic populations. The response of non-European non-Asian Oceanian populations to Pfizer COMIRNATY vaccination has not been specifically studied at this time. According to the 2019 census in New Caledonia, 41.2% of the population identified themselves as Kanak (Melanesian), 24% as European, 8.3% as Wallisian-Futunian (Polynesian), 11% as mestizo, and 8% as belonging to other communities including Tahitian (Polynesian), Indonesian, Ni-Vanuatu (Melanesian), and Vietnamese communities (8). Some recent data are in favor of a significant variability of susceptibility to pathogens in Oceanian populations, stemming from a genetic inheritance from Neanderthal man and his cousin Denisova man. In a context of vaccine hesitancy, it is therefore important to ensure that the immune response of the New Caledonian population (Melanesian, Polynesian, European or other communities) to vaccination against COVID-19 is similar to that of populations studied in large clinical trials.
The need for multiple night testing is well recognized in sleep medicine because of a considerable and relevant night-to-night variability. In a study with multiple recordings using WatchPAT®, the OSA severity of 24% of patients was misclassified when using one night compared to the average of three nights. On average, pAHI varied by 57% from night-to-night. The variability of pAHI could partially be explained by the variability of time spent in the supine position with more time supine leading to a higher pAHI (Tschopp et al 2021). Smith (2007) suggested that the AHI should be indicated with a confidence interval to indicate the uncertainty regarding its true value. The Minimal Detectable Difference (MDD) is of special interest in sleep medicine, especially when assessing treatment effects. MDD was found to be 12.8/h and the standard error of measurement was 4.6/h for 4 nights of polysomnography (Aarab et al. 2008). For WatchPAT®, measuring two and three nights showed a small reduction in MDD from 19.1/h to 18.0/h (Tschopp et al. 2021, in press). Only one study using pulse oximetry assessed the night-to-night variability over 14 days (Stöberl A. et al 2017). The study confirmed the enormous variability and focused mainly on its impact on OSA severity. While the night-to-night variability has been extensively studied for polysomnography, respiratory polygraphy, and WatchPAT®, little is known about the optimal number of nights to be recorded. There is convincing evidence from the literature, that the recording of multiple nights is the only way to assess the severity of the patient's disease with clinically reasonable accuracy. Moreover, the MDD with only one night's recording is astonishingly high. The question is how many nights should be recorded to achieve acceptable diagnostic accuracy. The precision of the OSA measurement depends on the clinical situation. For example, to diagnose severe OSA, a higher variability might be acceptable without influencing the treatment decision. However, when comparing treatment effects, the MDD should be as small as possible. The recording of multiple nights might be cumbersome for patients (e.g. with polysomnography or respiratory polygraphy) as well as costly. These factors have to be taken into consideration for the clinically feasible number of recordings. Sleepiz One Connect offers the unique opportunity for a contactless recording of breathing combined with conventional pulse oximetry and is a minimally invasive diagnostic tool that allows measurements over several nights. Studies with multiple night recordings will offer a basis for diagnostic recommendations in future guidelines. The study aims to investigate the variability of obstructive sleep apnea at-home sleep apnea testing. By investigating the variability, we want to quantify the improvement in diagnostic accuracy by additional measurements. The hypothesis is that additional recordings offer a significant improvement in diagnostic accuracy by reducing the variability. The reduction in variability will diminish with each additional recording.
Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. NAVA is a ventilation mode that uses the electrical activity of the patient's diaphragm (Edi-signal) to guide both timing and magnitude of the support. However, it is unknown whether NIV-NAVA is superior to NIPPV in preventing extubation failure and preventing BPD. Hence, the investigators aim to compare the effect of NIPPV and NIV-NAVA on diaphragm function in premature infants with RDS or evolving BPD. Our hypothesis is that infants treated with NIV-NAVA will have improved diaphragmatic function and lung scoring.
Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.