Clinical Research Directory

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

Study of Lung Proteins in Patients With Pneumonia

This study will examine the different types of proteins present in the lungs of patients with pneumonia to explore the causes of different types of the disease. Pneumonia is a condition that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by lung x-rays and listening to the chest with a stethoscope. This method can diagnose pneumonia, but it does not provide information on the cause of the inflammation - information that might be helpful in guiding treatment. This study will measure proteins in the lungs of patients to see if certain proteins are associated with specific forms of pneumonia, and can thus serve as biomarkers for disease. Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for their medical care. For this procedure, the patient's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Saline (salt water) is then injected through the bronchoscope into the air passage, acting as a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content. In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2 tablespoons of blood drawn to compare blood test results with the results of the lung washings. Patients' medical records will be reviewed to obtain information on past medical history, current medical treatment, vital signs, and results of x-ray tests. ...

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.

Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time.

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.

Merck IIT: RRP Pembro and Lenvatinib

This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP). The names of the study drugs involved in this study are: * Pembrolizumab * Lenvatinib

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection

The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.

Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study

The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module. The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies. The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.

Cooperative Assessment of Late Effects for SCD Curative Therapies

Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with \>99% of those born in high resource settings, including the United States, France, and England, now surviving to 18 years of age. However, the life expectancy of adults with SCD is severely shortened. Dysfunction of the heart, lung, and kidney is directly associated with decreased life expectancy. With the variety of curative therapies that are now available for SCD, long-term health outcomes studies are time-sensitive. As of now, efforts to determine long-term health outcomes following curative therapies for SCD have been limited. Though curative therapies initially should provide a cure for symptoms of SCD, there is the risk of late health outcomes to consider. Defining health outcomes following curative therapy is essential to improve personalized decision-making when considering curative versus disease-modifying therapeutic options. The primary goal of this study is to determine whether curative therapies for individuals with SCD will result in improved or worsening heart, lung, and kidney damage when compared to individuals with SCD receiving standard therapy. The investigators will also explore whether certain genes are associated with a good or bad outcome after curative therapy for SCD.

Advanced Imaging Holistic Omics Biobank

Imaging methods today represent the pillar of prevention, diagnosis, patients monitoring and treatment. Improvement in technology led the development of increasingly high-performance scanners whose potential has not yet been fully explored. In particular, recently introduced photon counting CT scanner and new high filed MRI offers a lake of latent information derived from the images (e.g. spectral data from CT) of potentially great interest and potentially able to provide new insight but that are currently mostly unexplored .These features are also called "opportunist features" because they are in each exam and can be freely derived from images without changing the study protocol used for clinical practice examination but extracted a posteriori from the images representing a precious source of deep characterization of the patients, equally or even more than a genomic analysis, with possible high relevance in the field of screening and prevention, being able to contribute to defining signatures indicating a particular risk of remotely developing a specific pathological condition. The prospective collection of clinical and imaging data from subjects undergoing diagnostic tests with advanced technology has the potential to increase knowledge of the pathophysiological mechanisms of different pathological conditions, to explore and validate the diagnostic-predictive value of opportunistic features not currently used in practice clinical, to increase the diagnostic and prognostic accuracy of CT and MRI examinations and to provide a unique pool for scientific research. Previous relevant experience was conducted in the United Kingdom (UK biobank) where data from over 500,000 patients have been collected in the last 10 years, providing an enormous pool for spontaneous and funded scientific research. This project (UK biobank), although of enormous scientific value, is currently obsolete in terms of the imaging technology used.

Abdominal and Core Exercises on Respiratory Functions in Obese and Overweight Women (COREBREATH)

This study aims to examine the effects of an 8-week Pilates-based exercise program on breathing functions in overweight and obese women (BMI ≥ 25). The program includes exercises for abdominal endurance and core stabilization, performed three times a week. Participants will be divided into two groups: an exercise group and a control group. Before and after the program, measurements will include lung function (spirometry), breathing rate, breath-holding time, abdominal mobility, core endurance (curl-up test), and quality of life (SF-36 questionnaire). The goal is to find out whether this type of exercise can improve breathing and overall health in women with excess weight.

Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.

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.

OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals

Cardiovascular disease (CVD) causes a quarter of all deaths in the United Kingdom (UK). This is the single biggest area where the National Health Service (NHS) can save lives by detecting and treating risk factors early. Improvements in control of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown to reduce the risk of CVD and death. The NHS has guidelines for investigations and treatments for risk factors recommended by the National Institute for Health and Care Excellence (NICE). Though it is known that better control of risk factors will reduce the risk of CVD the investigators do not know whether having extra appointments in primary care with heart specialists can lead to better treatment and better control of risk factors. The OPTIMISE trial (OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals) will compare patients who have consultations at a local General Practitioner (GP) practice by a cardiology professional to optimise the treatment of their risk factors (OPTIMISE) with those patients who receive standard care (Standard care). Standard care is patients being seen by their GP at routine care appointments. Participants in the OPTIMISE arm will be reviewed by the cardiology professional and recommended treatment in line with current NICE guidance. They will be seen at 3 months to review their treatment and potentially adjusted to ensure it meets NICE guidelines. Participants in the standard arm will have data related to their cardiovascular, renal, metabolic and pulmonary risk factors collected through their Electronic Health Record (EHR). At 6 months, all participants will be seen to find out changes to their prescribed medication and the effect of this on their blood pressure, cholesterol, blood sugar level, and body mass index (BMI). All participants will also complete a quality of life questionnaire prior to randomisation study and at 6 months to identify any differences between the arms and time points.

Patient Experiences and the Role of Team Structures in Pulmonary Rehabilitation in Türkiye

The PRETTY Study aims to evaluate patient satisfaction with pulmonary rehabilitation (PR) services across Türkiye and to investigate how satisfaction levels are related to the organizational structures and team compositions of the PR programs. This national, multicenter, cross-sectional observational study will also identify structural and organizational factors that may enhance patient-centered care and promote the standardization of PR services.

Evaluating the Impact of Preoperative Respiratory Exercises on Post-Surgical Pulmonary Outcomes RCT

This randomized controlled trial aims to evaluate the role of preoperative respiratory exercises in reducing postoperative pulmonary complications (PPCs) such as atelectasis, pneumonia, and hypoxia, and in shortening the hospital stay in surgical patients. A total of 126 adult patients (\>40 years), scheduled for total knee or hip replacement surgeries at Horizon Hospital Lahore, will be randomly assigned into two groups: the intervention group and the control group.

Feasibility, of Tele-rehabilitation Following COVID-19

Since initial reports of a novel coronavirus emerged from Hubei province, China, the world has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by 30th April 2020. Health care systems around the world have struggled to cope with the number of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus). Although the majority of people infected with the virus have a mild disease, around 20% experience a more severe illness leading to hospital admission and sometimes require treatment in intensive care. People that survive severe COVID-19 are likely to have persistent health problems that would benefit from rehabilitation. Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improve physical and social performance and is typically provided for people with chronic lung conditions. PR courses typically last 6-12 weeks with patients attending classes once or twice weekly and consist of exercise and education components. PR is known to improve symptoms (e.g. breathlessness), quality of life and ability to exercise in those with lung conditions. Breathlessness is a very common symptom reported by people presenting to hospital with COVID-19 and loss of physical fitness will be very common. Using existing pulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitation programme (a programme that will be delivered using video link to overcome the challenges faced by social distancing and shielding advice) for people that have been critically ill with COVID-19. In order to prove whether people benefit from this tele-rehabilitation programme after being admitted to hospital following COVID-19 we would need to perform a large clinical trial. However, before doing this it is important for us to answer some key questions: * How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital? * Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge? * Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist? * Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.

Risk Underlying Rural Areas Longitudinal Cohort Study (RURAL) Heart and Lung Study

The University of Texas Health Science Center at San Antonio (UTHSCSA) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD. The primary function of the Study Coordinating Center (SCC) is to serve as an administrative liaison between all of the RURAL study's cores. The SCC schedules, facilitates, and hosts, all RURAL meetings including preparation for Observational Study Monitoring Board (OSMB) meetings, and maintains direct communication with the study's program officers at NHLBI. The SCC monitors the overall progress of RURAL and keeps all RURAL cores abreast of study updates through meetings, emails, newsletters. It also maintains the official RURAL website and serves as an administrator for investigators seeking to collaborate with RURAL through the submission of Ancillary Studies. The SCC will have no direct interaction with any participants, nor will it have access to identifiable data.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Pulmonary Diseases

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Pulmonary Diseases

Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on: The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

Distribution of Ventilation, Respiratory Drive and Gas Exchange: Measurements and Monitoring

Respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. Body position may also play an important role in respiratory mechanics. While effective methods exist for measuring these variables, they are typically measured in isolation rather than in combination. In pulmonary disease, decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse are central to clinical management. Obesity has a significant impact on pulmonary mechanics and is a risk factor for obstructive sleep apnea (OSA). However, our understanding of these elements is limited even in the general population. The investigators plan to use various validated methods to assess control of breathing, respiratory drive, distribution of ventilation and gas exchange to obtain a better understanding of underlying physiologic signatures in patients with and without obesity and the role of posture/position, with a secondary analysis comparing participants with and without obstructive sleep apnea.

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).