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47 active trials for Pulmonary Disease

Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

Background: - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH. Objectives: - To study the natural history of PAH. Eligibility: Individuals at least 18 years of age who have PAH. Healthy volunteers at least 18 years of age. Design: Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues. The first visit will take up to 3 days. It will involve the following tests: Physical exam and medical history Blood and urine samples Heart and lung function tests and imaging studies Six-minute walk test Questions about exercise and physical activity Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH

Start: July 2013

Effects of Using Mask During the 6-minute Walking Test in Times of COVID-19

Since the beginning of the pandemic caused by SARC-CoV 2, more than 81 million cases have been diagnosed and caused around 1,7 million deaths. Currently, a drug is being sought for the treatment of coronavirus. The worldwide effort to create an effective and safe COVID-19 vaccine is beginning to yield results. Several vaccines now have been authorized around the globe; many more remain in development. Nonetheless, in the absence of effective pharmacological treatment and given the virus's transmission capacity, different alternatives have been proposed to stop the transmission of the virus. Therefore, these preventive measures against transmission are expected to remain in force for some time. The transmission of the virus occurs from person-to-person; different studies conclude that transmission occurs by aerosols from respiratory droplets. The optimal distance between people to stop person-to-person transmission is uncertain. For this reason and given that there is no effective drug, transmission prevention is of great importance especially for pandemic mitigation in community settings. The World Health Organization (WHO) established simple precautions to prevent the spread of the virus such as physical distancing, wearing a mask, keeping rooms well ventilated, avoiding crowds, cleaning your hands, and coughing into a bent elbow or tissue. For this reason, the use of the mask has been proposed in several countries, being mandatory in many of them, for use in the health environment and daily use. The WHO recommends different types of masks depending on the person, where it will be used, or the population incidence in the area. Wearing a medical /surgical mask is recommended for people over 60, those who have underlying medical conditions, feel unwell, and/or look after an ill family member. For health workers, respirator masks (such as FFP2, FFP3, N95, N99) should be used in settings where procedures are generating aerosols. The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling of discomfort in many people. It is responsible for an increase in the inspiratory and expiratory pressures generated. This feeling of discomfort and the increment of pressures causes shallow and forced breathing and increases the respiratory accessory musculature activation. Person et al. observed that the subjects who used a mask felt dyspnea clinically and significantly higher than those who did not use it. However, to our knowledge, no study has analyzed the parameters of physical effort, respiratory parameters, self-perceived dyspnea, and muscle activation using different types of masks in healthy subjects. For this reason, the present study hypothesis is that there are no changes between wearing and not-wearing a mask (surgical or N-95) in the effort and ventilatory parameters, even though there may be an increase in the tone of the cervical muscles or the perception of dyspnea using a face mask. This study aims to observe the effect that the surgical mask and the N-95 mask have in the distance walked, in the oxygenometry, in the heart rate, in the sensation of dyspnea, and the tone of the inspiratory accessory muscles during the 6 minutes walking test. Procedure After verifying that the subjects meet the inclusion criteria and sign the consent, they will be given a registration number. An investigator will observe the number in a random list and included the participant in one of the three groups (without a mask, with a surgical mask, and with N95 mask). This researcher will make an initial registration of demographic data (gender, age, weight, height, cardiorespiratory pathology, smoker, number of cigarettes per day, a sport performed, hours of daily sport, and days of sport per week). Before the test, all the subjects will have to remain for 30 minutes without a mask, breathing normally. This phase will be called the resting phase. Subsequently, the subjects will go to the area where the 6MWT will be carried out. Each one of them will be performed the test according to the group to which they will be assigned. An investigator, blinded to the subsequent assessment, will encourage the participants to take the 6MWT according to the recommendations mentioned above. After performing the 6MWT, all subjects will go to the assessment area. All the subjects will wear a surgical mask so that the researcher can not know to which group they have been assigned. Besides, this researcher will not have access to the registration number or the 6-minute walking test area. At the end of each resting phase, SpO2 and baseline HR will be recorded. After every 6MWT, the HR, SpO2, and self-perceived dyspnea will be recorded. The muscle tone will also be assessed with the MyotonPRO in middle scalene and SCM. Subjects will have the option of retaking the test, going through all the phases mentioned above.

Start: May 2021

A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders

Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited palliative care (PC) clinical expertise. Secondly, although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The purpose of this study is to compare a culturally-based Tele-consult program to usual hospital care to determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized African American and White older adults with a life-limiting illness.

Start: August 2020

E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease

This study is designed to enhance the understanding of the possible health effects of e-cigarette use by relating the acute and long-term use of e-cigarettes and conventional cigarettes ("products") to well-validated cardiovascular and pulmonary disease biomarkers. Participants will be enrolled in 3 groups: exclusive e-cigarette users, exclusive cigarette smokers, and a control group of never-users. Participants can expect up to 4 weeks of study participation.

Start: March 2019

Quantitative Lung Cancer Screening

The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.

Start: July 2021

The ESTxENDS Trial: Pulmonary Function Substudy

Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. The inhaled ENDS aerosol appears safe in laboratory conditions, its long-term effects on pulmonary function remains unknown. This study will therefore investigate the impact of ENDS on lung function in smokers, who attempt to quit using ENDS compared with smokers, receiving only smoking cessation counseling with nicotine replacement therapy (NRT). Multiple breath washout (MBW) is an established technique for assessment of peripheral airway function in pediatrics and its use is emerging in adult medicine, as it offers a better sensitivity to assess small airway disease before large airway involvement can be detected using conventional pulmonary function tests (PFT - spirometry, body plethysmography and diffusing capacity test). Preliminary evidence from limited studies suggest MBW parameters (LCI, Scond, Sacin) can be impaired in smokers with normal lung function and improve after smoking abstinence. Primary objective of this substudy is to assess changes in LCI from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group. For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive standard of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. Participants in the control group will receive only standard of care. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.

Start: April 2019

Non-Invasive Measurement of Cardiac Output and Stroke Volume in PE

Pulmonary embolism impacts over 1 in 1000 adults annually and is the third leading cause of cardiovascular death after heart attack and stroke. The consequence of each PE is widely variable. Physiologically, the morbidity and mortality of PE is ultimately caused by failure of the right ventricle. The acute rise in pulmonary vascular resistance caused by a PE can overwhelm the right ventricle, resulting in a drop in cardiac output and death from failure of the heart to provide vital perfusion. Despite the importance of stroke volume and cardiac output in the current understanding of PE mortality, they are notably absent from risk stratification scores because they historically could only be measured invasively. Novel non-invasive methods of estimating stroke volume and associated cardiac output have the potential to revolutionize PE risk stratification and care. Non-invasive blood pressure (NIBP) monitors can even measure stroke volume beat to beat, allowing for continuous evaluation of cardiac function. NIBP systems are typically composed of a finger cuff with an inflatable bladder, pressure sensors, and light sensors. An arterial pulse contour is formed using the volume clamp method of blood pressure measurement combined with calibration and brachial pressure reconstruction algorithms. The stroke volume with each heart beat can be estimated as the area under the systolic portion of the blood pressure curve divided by the afterload. NIBP monitors may improve clinical care of PE because they allow for assessment of dynamic cardiac changes in real time. Detection of worsening stroke volume in acute PE could inform providers of impending cardiac collapse, and improvement of stroke volume may function as a positive prognostic factor or marker of therapeutic success. Use of NIBP monitors during acute PE to identify clinically significant changes in cardiac function may advance both PE prognostication and management. Our clinical study proposes to monitor hemodynamic parameters including stroke volume in patients with acute pulmonary embolism using non-invasive blood pressure monitors. The relationship between hemodynamic parameters and PE outcomes will be assessed, as well as the changes in hemodynamic parameters with PE intervention. To our knowledge, interval monitoring of stroke volume during acute PE with NIBP monitors has never been reported before.

Start: May 2021

DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and non-invasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.

Start: August 2020

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Start: August 2017

DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer

The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.

Start: September 2011

MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery

Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.

Start: March 2021

Robotic-assisted Exercise Training in Heart Failure

Background: Regular physical activity is an evidence-based adjuvant therapy of chronic heart failure or chronic lung diseases. Structured exercise training is safe, increases exercise capacity and quality of life, relieves symptoms and reduces hospitalization rates. Even a trend towards reduction of mortality has been identified. However, dyspnea and fatigue, typical symptoms of heart or lung failure, force patients to physical inactivity which fatally aggravates deconditioning and exercise intolerance, leading to an increased risk of hospitalization and a loss of independence and quality of life. To break through this vicious circle physical activity must be restored, since exercise intolerance can be successfully improved by physical training. Purpose: This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (fig. 1) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The investigators hypotheses that an exosuit-supported training increases exercise capacity and quality of life in a greater degree than non-supported training. Methods: The study will consist of two parts investigating i) the feasibility, tolerance and safety (n= 30) and ii) the efficacy of an exosuit device-supported training (n=30). In i) patients will perform a walking test and a set of everyday life skills or participate in a standardized rehabilitation sports program. In ii) patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed.

Start: March 2021

Measurement of Physical Activity in the First Days After Thoracic Surgery

Objective measurement of physical activity has several advantages compared to declarative measures: exemption from memory bias and desirability bias, more precise evaluation, taken into account activities of low intensity, measurement of physical activity and sedentariness profiles (number and duration of periods of activity, number of breaks in sedentary lifestyles). The aim of this study is to assess the early postoperative mobility of patients who have undergone pulmonary excision by thoracoscopy or robot surgery using ActiGraph GT3X accelerometer. This assessment will serve as a reference element for further studies.

Start: November 2020

Accessing Mobility Using Wearable Sensors

This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention. The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as Chronic obstructive pulmonary disease (COPD) or Congestive Heart Failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (e.g., LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via tele-medicine (tele-rehabilitation) can enhance motor-cognitive performance.

Start: May 2018

The Effect of Hospital Fit 2.0 on Patients Physical Activity

The primary objective of this study is to investigate if using Hospital Fit 2.0 as part of the usual care physiotherapy treatment of patients hospitalised at the department of Internal Medicine and the department of Pulmonology in MUMC+ will result in an increase in the amount of PA performed compared to patients who do not use Hospital Fit 2.0 as part of the physiotherapy treatment.

Start: March 2021

CENTR(AR): Lungs Moving

Chronic Respiratory Diseases (CRDs) are associated with substantial morbidity and mortality, ranking as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a fundamental evidence-based intervention for the management of a variety of CRDs, such as Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Diseases (ILDs). However, the benefits of PR tend to decline over time and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. There is an urgent need for evidence-based interventions to promote physical activity (PA) participation, whilst maintaining PR positive effects in the long-term. Community-based PA interventions adjusted to the local context, as well as patients' needs and preferences, might be a key strategy to meet this target. CENTR(AR) will be a sustainable response to support healthy lifestyles and enhance long-term PR benefits, by providing access to PR within Primary Healthcare Centres (PHC), followed by the inclusion in a community-based PA program, which embraces urban facilities and available resources.

Start: April 2021

Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.

The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

Start: December 2020

A Non-pharmacological Cough Control Therapy

Coughing affects almost all individuals with ILD leading to physical, psychological and social distress and prevents individuals from performing their activities of daily living, working or socialising in public places. Unfortunately, there are no licensed medications available to treat chronic cough and the few drugs that have been tried resulted in little efficacy and significant side effects. Drug-free cough control interventions have shown promise in reducing the severity and impact of coughing on patients' lives but have not been tested in individuals with ILD. This study aims to explore the feasibility and effectiveness of a non-pharmacological cough control therapy, as an adjuvant of pulmonary rehabilitation, in patients with ILD and chronic cough (>8 weeks in duration).

Start: September 2020

Preoperative Evaluation of Pulmonary Vascular Anatomy by Holograms

Pulmonary vascular anatomy represents a constant challenge during lung resection, because of its variability in terms of vascular branches and anatomical variations. Preoperative standard computed tomography is not always sufficient to foresee tricky abnormalities; augmented reality, thanks to holograms creation, may offer additional data on pulmonary vascular anatomy and its relation with neoplastic tissue. The aim of this study is to assess the possibility of correctly predict number, location and potential anomalies of pulmonary vascular anatomy of the lobe to be resected in patients undergoing lung resection for cancer. Patients will receive standard preoperative oncologic and functional assessment. Preoperative computed tomography (CT) - performed according to a specific protocol - will be performed. CT images will be subsequently elaborated to generate 3D images (holograms). Two radiologists and two thoracic surgeons will analyze CT images and report number of artery and vein branches for the lobe to be resected. Moreover they will report every anatomical variation, according to the normal anatomy. After that, the same two radiologists and thoracic surgeons will analyze the holograms and perform the same analysis as quoted above. Patients will undergo to the planned surgical resection. The operating team will report the exact number of artery and vein branches of the resected lobe as well as every anatomical variation. Preoperative CT and holographic findings of the radiologists and the thoracic surgeons will be matched with the report of the operating team.

Start: March 2020

Bia?ystok PLUS - Polish Longitudinal University Study

The main goal of the study is to provide a unique multidimensional picture of the health of the population with simultaneous optimal standards of sampling, processing and storing of data and biomaterial that will allow discovering novel mechanisms in the development and progression of common civilization diseases. In the effect it will improve prevention, diagnosis and treatment.

Start: November 2018