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Emphysema clinical trials

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NCT ID: NCT04302272 Recruiting - Emphysema Clinical Trials

STRIVE Post-Market Registry Study

Start date: October 9, 2021
Phase:
Study type: Observational [Patient Registry]

This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.

NCT ID: NCT04214587 Recruiting - Emphysema or COPD Clinical Trials

Biological Investigation of Explanted Endobronchial Lung Valves Study

Bio-EXCEL
Start date: March 16, 2021
Phase:
Study type: Observational

Rationale: COPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone/nitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions. Objective: The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.

NCT ID: NCT04200079 Recruiting - COPD Clinical Trials

Kingston Chronic Obstructive Pulmonary Disease (COPD) Multidimensional Long Term Follow up Cohort

KCOCO
Start date: January 14, 2020
Phase:
Study type: Observational [Patient Registry]

Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic complex patient. Their follow up can sometimes be difficult and challenging (1). There are patients with recurrent exacerbations that put an enormous burden on health care resources (2). They also have multiple comorbidities (3) that can sometimes make their management difficult. In an attempt to coordinate all these efforts KGH, HDH and Providence Care have numerous essential resources to take care of COPD patients like the nurse navigators, nurse practitioners and the pulmonary rehabilitation program. These programs provide an excellent support to the clinical activity of Respirologists and other health care providers. Rationale: The main rationale for the development of the Kingston COPD cohort is to translate that highly demanding clinical activity in a teaching and research oriented activity that could be used by clinicians, medical students, residents and fellows. Having a guideline complained established protocol in COPD patients that are usually follow at KGH and HDH could help in not only in unified the way COPD patients are seeing (preserving the importance of the personalized approach) but most importantly established a multidimensional (clinical, physiological, radiological, laboratory) database. This could help know not only the results of our clinical activity but also have a long term (>5yrs) database for clinical research projects in collaboration with national and international research groups. Therefore this proposal is important because it will help translate our busy daily clinical work in a highly productive teaching and research activity.

NCT ID: NCT03755505 Recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients

COPD
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

Extensive studies suggest composition of microbiome of respiratory samples or lung tissues in COPD patients is different from the composition of healthy smokers. Aim of this study is to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to describe difference of composition between COPD patients and healthy smokers.

NCT ID: NCT03680495 Recruiting - COPD Clinical Trials

Steroid Resistance During COPD Exacerbations With Respiratory Failure

Start date: July 21, 2017
Phase:
Study type: Observational [Patient Registry]

Chronic obstructive pulmonary disease (COPD) is a lung disease caused by cigarette smoke that affects millions of people. In the United States, COPD is the 3rd leading cause of death making it one of our most important public health problems. Some people with COPD get disease flares that are called acute exacerbations of COPD - or AECOPDs for short. When people get an AECOPD they experience increased shortness of breath, wheezing and cough; symptoms that often require urgent or emergent treatment by healthcare providers. In the most severe, life-threatening situations, people with AECOPDs are put on a ventilator in the emergency department and admitted to the intensive care unit. Most AECOPDs can be treated with low doses of medications called steroids. This is good because high doses of steroids can cause unwanted side effects. Unfortunately, recent studies suggest that the sickest people, those admitted to the intensive care unit needing ventilator support, need higher doses of steroids because they may have resistance to these important medications. The investigators are studying steroid resistance during very severe AECOPDs so that we can eventually develop better and safer therapies for these vulnerable people.

NCT ID: NCT03500731 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure

Start date: April 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.

NCT ID: NCT03455686 Recruiting - Asthma Clinical Trials

Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease

Start date: April 19, 2018
Phase: N/A
Study type: Interventional

This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in individual patients with and without lung disease to better understand lung structure and function and evaluate response to therapy delivered as a part of clinical care.

NCT ID: NCT03382106 Recruiting - Emphysema Clinical Trials

Smoking Cessation and Functional CT Assessment

Start date: March 19, 2018
Phase: Phase 4
Study type: Interventional

The investigators will study the effect of pulmonary arterial vasodilation to see if it eliminates indices of persistent lung injury in smokers that are susceptible to emphysema.

NCT ID: NCT03318406 Recruiting - Emphysema or COPD Clinical Trials

Post-Market BTVA Registry

Start date: March 22, 2018
Phase:
Study type: Observational [Patient Registry]

Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.

NCT ID: NCT03285100 Recruiting - Cystic Fibrosis Clinical Trials

The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation

Start date: October 31, 2017
Phase: N/A
Study type: Observational

Background: Elastin is a unique protein providing elasticity, resilience and deformability to dynamic tissues, such as lungs and vasculature. Elastin fibers are characterized by their high affinity for calcium. However, calcified elastin is more prone to the degrading effects of proteases and, in turn, partially degraded elastin has an even higher affinity for calcium. A disturbed balance between proteases and anti-proteases is a major underlying mechanism in the development of chronic obstructive pulmonary disease (COPD). Virtually the only protein that can protect elastin from calcification is matrix Gla-protein (MGP), which needs vitamin K for its activation. In COPD patients, a lower vitamin K status is found when compared to control subjects and an inverse association exists between vitamin K status and elastin degradation. In addition, vitamin K status is lower and elastin degradation is accelerated in Vitamin K antagonist (VKA) users. VKAs are widely used. Nowadays, an increasing number of patients uses direct oral anticoagulants (DOACs), which do not influence vitamin K status. The hypothesis of this study is that discontinuation of VKAs results in an improved vitamin K status and deceleration of elastin degradation. In order to test this hypothesis, an observational pilot study will be conducted in which the change in elastin degradation- quantified by plasma desmosine concentrations - in patients who discontinue use of VKAs will be used as primary endpoint. Study design: Observational study. Study population: A total of 30 VKA users who will discontinue the use of VKAs. Elastin degradation rate (quantified by plasma desmosine levels) and vitamin K status (quantified by measuring plasma levels of dephosphorylated uncarboxylated (dp-uc)MGP) will be measured during the use of VKAs and approximately 6 months after discontinuation of VKAs. Furthermore, the VKORC1 polymorphisms will be determined. Main study parameters: The primary endpoint is the change in the rate of elastin degradation quantified by the plasma desmosine assay. Secondary endpoints are the change in vitamin K status quantified by measuring plasma levels of dp-ucMGP, the relation between desmosine and dp-ucMGP and differences of desmosine and dp-ucMGP levels among subjects with different polymorphisms of the vitamin K 2,3-epoxide reductase complex 1 (VKORC1) gene.