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Lung Diseases clinical trials

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NCT ID: NCT05661435 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of COPD

Start date: March 15, 2023
Phase:
Study type: Observational

Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow and discharge patients from hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home spirometry

NCT ID: NCT05466747 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema

Start date: January 1, 2024
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of RYMPHYSIA [Alpha1-Proteinase Inhibitor (Human)] compared to another available alpha-1 proteinase Inhibitor (A1PI) in adults with A1PI deficiency and COPD-emphysema. In Part A of the study, participants will be randomly assigned to receive either RYMPHYSIA or another available A1PI for 104 weeks. Participants who were randomized to another available A1PI will enter a 2-week follow-up period after the treatment phase is completed; participants who were randomized to RYMPHYSIA will enter Part B. In Part B, participants will be randomly assigned to one of two groups and will receive either the same dose of RYMPHYSIA as in Part A or a different dose for an additional 104 weeks, followed by a 2-week follow-up period.

NCT ID: NCT05100160 Withdrawn - Pulmonary Disease Clinical Trials

Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)

NCT ID: NCT05009485 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.

NCT ID: NCT04854967 Withdrawn - Clinical trials for Pulmonary Disease, Chronic Obstructive

Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD

RELIEF Pilot
Start date: April 18, 2022
Phase: N/A
Study type: Interventional

The investigators want to decrease inappropriate oxygen use for patients with COPD. The investigators are testing a new program that will stop oxygen prescriptions for patients that no longer need it and will instead provide them with training in skills that have been shown to help patients breathe better. Participants will be randomly assigned to receive the intervention program or usual care. After 12 weeks the investigators will determine if the program helped stop unnecessary oxygen prescription. The investigators will also determine if health status, distance walked during six minutes, and symptoms of breathlessness after walking are different between participants who received the program and those who did not. The investigators will meet with participating patients and their providers after the study is complete to find out how they feel about this program and if it would be possible to put this change into practice.

NCT ID: NCT04446637 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD

Start date: September 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare acute bronchodilator effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination in Patients with stable moderate-severe-very severe COPD.

NCT ID: NCT04440488 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study

Start date: March 8, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous lung tissue measured by lung density change in participants with A1PI deficiency and COPD-E.

NCT ID: NCT04419428 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

A40 Expiratory Flow Limitation Registry

Start date: February 2024
Phase:
Study type: Observational [Patient Registry]

This prospective observational multicenter registry study will include adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as part of standard medical care. For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic respiratory failure consisting of historical spirometry vales (FEV1 <60% predicted and FEV1/VC < 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked to participate. The anticipated study duration will be 6 months. The study will involve an initial visit for the standard of care initiation of home noninvasive ventilation. At this time, potential participants will be screened for participation. If eligible once consented, medical history will be collected and baseline questionnaires related to their respiratory disease will be completed. The registry study will include 6 month of home use of the noninvasive ventilator using the BiPAP A40 EFL device. Study staff will reach out to participants on a monthly basis to review any issues, medication changes, unscheduled visits, and device data download. Additional phone calls and or visits may occur on an as needed basis if issues arise. The final visit will be an in facility visit. The primary endpoint will be the overall prevalence of Expiratory Flow Limitation (EFL) in ventilated hypercapnic COPD patients, as defined as the percentage participants exhibiting a DeltaXrs value greater than or equal to 2.8 during one or more nights of therapy.

NCT ID: NCT04221100 Withdrawn - Pulmonary Disease Clinical Trials

xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation by Radiologists

Start date: March 2021
Phase: N/A
Study type: Interventional

xrAI (pronounced "X-ray") serves as a clinical assistance tool for trained clinical professionals who are interpreting chest radiographs. The tool is designed as a quality control and adjunct, limited, clinical decision support tool, and does not replace the role of clinical professionals. It highlights areas on chest radiographs for review by an interpreting clinician. The objective of this study is to utilize machine learning and artificial intelligence algorithms (xrAI) to improve the quality and efficiency in the interpretation of chest radiographs by radiologists. The hypothesis is that the addition of xrAI's analysis will reduce inter-observer variability in the interpretation of chest radiographs and increase participants' sensitivity, recall, and accuracy in pulmonary abnormality screening.

NCT ID: NCT04143776 Withdrawn - Acute Kidney Injury Clinical Trials

Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction

REPARE
Start date: June 1, 2020
Phase:
Study type: Observational

An incisional hernia is technically challenging to operate and is the most frequent long-term complication after open surgery, resulting in impaired quality of life and reduced physical ability. Large hernias contain large amounts of abdominal volume, which similarly are missing from the abdominal cavity. Due to adaptations of the abdominal wall muscles and decreased space in the abdominal cavity, abdominal wall reconstruction lead to increased tension and thereby increased intraabdominal pressure. Reduced renal and lung function after surgery is one of the leading causes of prolonged hospitalization, increased costs and mortality. Elevated intraabdominal pressure is a known risk factor for kidney injury, but relationships between hernia surgery, increased intraabdominal pressure, renal and lung function are still unclear. Therefore, in patients undergoing surgery for incisional hernia, we will investigate the extent and consequences of elevated intraabdominal pressure, as well as its relation to renal injury and reduced lung function. We will also investigate the relationship between hernia dimensions and the development of increased intraabdominal pressure, as well as identifying patients at particular risk of developing elevated intraabdominal pressure. From April 2020 to October 2021, we will include 100 patients at Bispebjerg Hospital, Denmark, diagnosed with medium to giant incisional hernia, who will undergo scheduled surgery. Patients are followed from before to 30 days after surgery. They will be examined with CT scans before and after surgery. Blood tests, pulmonary function tests and measurement intraabdominal pressure will be performed before and until 3 days after surgery. Thirty days after surgery, lung function tests and blood tests are repeated at a final examination at the out-patient clinic. During follow-up, differences in hospital stay, complications, reoperations, and mortality will be investigated. Participation in the project is not associated with any side effects and risks. The study is expected great scientific gain, as the results can help identify particularly vulnerable patients in need of extended observation and treatment. The results obtained by the project are sought to be published in relevant scientific journals and conferences. The project is expected to extend over a 3-year period, which will include commissioning, data collection, analytical processing, dissemination of results and conduction of PhD thesis.