View clinical trials related to Respiratory Tract Disease.
Filter by: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.
The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients
The purpose of this study is to examine if a new and simple method involving complete photo-protection of multivitamins only (since sampling through infusion) will result in a significant reduction of peroxide contamination of parenteral nutrition compared to standard method of parenteral nutrition preparation and infusion in extremely preterm infants.
This study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in CPAP-naïve obstructive sleep apnea patients. The aim of the study is to verify that this new modality achieves a lower titration pressure.
This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.
This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in New York State, through partnership with the New York State Health Department (excluding New York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this was decided as some of the intervention components are different enough that separate registrations were warranted. Despite U.S. guidelines for influenza vaccination of all children starting at 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using 4 clinical trials (2 per state) in two different states. The investigators will assess effectiveness and cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as compared to 4) standard of care control (no R/R).
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III, multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy naive and have Stage IIIB/IV non-squamous NSCLC. The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT population and population was indicated by high PD-L1 expression) compared to carboplatin and pemetrexed treatment .
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
Randomized clinical trial, controlled, double-blind, parallel two-arm.