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Search Results Within Category "Asthma/Lung Disease"

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

39 Study Matches

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)

The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation: * Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)? * Is taking one type of antibiotic just as good as taking two types?

Kelly Thornton - Kelly.Thornton@cchmc.org

ALL
6 years and over
PHASE4
This study is NOT accepting healthy volunteers
NCT05548283
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Inclusion Criteria:
* All genders ≥ 6 years of age at Visit 1 * Documentation of a CF diagnosis * Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials * At least one documented Pa positive culture within two years prior to Visit 1
Exclusion Criteria:
* Participant is not pregnant * No known renal impairment or history of solid organ transplantation * No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1 * No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1 * No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides * No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1
DRUG: Beta-lactam antibiotic, DRUG: Aminoglycoside
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360
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I-DECIDE After Bronchiolitis Hospitalization (I-DECIDE)

Although automatic follow-up is a nearly universal practice, research has shown that these visits are often unnecessary after hospitalizations caused by bronchiolitis. Despite endorsement by national pediatric authorities, robust evidence, and family enthusiasm for as-needed (PRN) follow-up, it remains substantially underutilized for children hospitalized for bronchiolitis. The goal of I-DECIDE is to compare the effects of two multi-component implementation strategies, both of which aim to (a) increase PRN follow-up prescribing by hospitalists (physicians who care for hospitalized children) and (b) decrease unnecessary follow-up visit attendance by families.

Ramya Ramya Adapa - RamyaSriLakshmi.Adapa@cchmc.org

ALL
0 months to 24 months old
NA
This study is NOT accepting healthy volunteers
NCT07243652
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Inclusion Criteria:
* Primary diagnosis of bronchiolitis, discharged by a generalist inpatient service from a non-ICU, non-emergency department, non-step down unit
Exclusion Criteria:
* Children with a history of gestational age \<28 weeks, chronic lung disease, complex or hemodynamically significant heart disease, immunodeficiency, or neuromuscular disease * Children being discharged with home oxygen therapy
OTHER: Moderate-Resource Implementation Strategy, OTHER: High-Resource Implementation Strategy
Bronchiolitis Acute
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Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) (MOONBEAM)

The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

Jaynee Bartsch - jaynee.bartsch@cchmc.org

ALL
1 year to 17 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT05587712
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Inclusion Criteria * Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes: * Idiopathic pulmonary arterial hypertension (IPAH) * Heritable PAH * Drug/toxin-induced PAH * PAH associated with connective tissue disease * PAH-congenital heart disease (CHD) with shunt closure \>6 months before Screening and subsequently confirmed by RHC before Screening * PAH with coincidental shunt. * Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids \[including subcutaneous and intravenous\]) * If male, agree to the following during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention: * Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or * Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below: * Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. * If female, must be either not a WOCBP or use a contraceptive method that is highly effective or be abstinent from heterosexual intercourse during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention * If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study intervention * If female, agrees to refrain from donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study intervention Exclusion Criteria * History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy) * Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm * History of Eisenmenger syndrome, Potts shunt, or atrial septostomy * Unrepaired or residual cardiac shunt * Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and/or venous involvement * PAH associated with portal hypertension * Known visceral (lung, liver, or brain) arteriovenous malformation(s) * History of full or partial pneumonectomy * Untreated more than mild obstructive sleep apnea * History of known pericardial constriction * Family history of sudden cardiac death or long QT syndrome * Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening * Cerebrovascular accident within 3 months before Screening * Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients
DRUG: Sotatercept
Pulmonary Arterial Hypertension
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Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry (PPHNet)

Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.

Sarah Speed - sarah.speed@cchmc.org

ALL
1 day to 21 years old
This study is NOT accepting healthy volunteers
NCT02249923
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Inclusion Criteria:
* The subject's age of onset of pulmonary hypertension must be prior to age 18 years * The person providing consent must be able to read either Spanish or English. * The subject (and/or parent/legal guardian) must be able to provide informed consent
Exclusion Criteria:
* Diagnosed with pulmonary hypertension after age 18 * Refusal to sign informed consent
Pulmonary Vascular Disease, Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease (PVD), Registry, Pediatric
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TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.

Sara Loveless - sara.loveless@cchmc.org

ALL
Up to 24 years old
This study is NOT accepting healthy volunteers
NCT04098445
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Inclusion Criteria:
* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.
Exclusion Criteria:
* Subjects over 24 years of age.
Hematopoietic Stem Cell Transplant (HSCT), Diffuse Alveolar Hemorrhage, Thrombotic Microangiopathies, Interstitial Pneumonitis, Bronchiolitis Obliterans
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Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders (HIBR-ACHD)

A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.

Olivia Croweak - olivia.croweak@cchmc.org

ALL
16 years and over
This study is also accepting healthy volunteers
NCT07477197
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Inclusion Criteria:

• Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
• Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
• A family member or other person accompanying a patient to a clinical encounter; or,
• A volunteer recruited via an advertisement; or,
• Another person who volunteers to enroll in HIBR-ACHD.
• A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
Exclusion Criteria:
* Unable to provide informed consent/assent personally or via a legal guardian. * Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator. * Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days.
Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
ACHD, Adult Congenital Heart Disease
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Assessing Pulmonary Changes in HSCT

This will be an un-blinded, open-label study of children and adults, including those who are being evaluated for or who have undergone HSCT, those with existing respiratory conditions and/or diagnosed gas-exchange impairment, and healthy control volunteers. The participants will be male or female between 3-17 years old (children) and adults age 18 and older. The study objective is to: * To optimize the acquisition of images reflecting the "dissolved-phase" Xe distribution in the pulmonary tissues and blood (Xe gas-exchange MRI). * To develop and test Xe MRI acquisition strategies that separately image alveolar airspace distribution (ventilation), as well as Xe dissolved in pulmonary tissues versus red blood cells (RBCs). * To acquire images of Xe ventilation and dissolved-phase Xe regional distribution in the enrolled participants. * To understand the same-day variability of Xe MRI techniques. * To determine the relationship between Xe MRI and clinical measures such as pulmonary-function-test (PFT) parameters or other biological biomarkers. * To develop and optimize strategies for Xe MRI in young children including those who are unable to follow the inhalation and breath-hold instructions typical of the Xe MRI procedure.

Ashley Borden, MPH - ashley.borden@cchmc.org

ALL
3 years and over
PHASE1
This study is also accepting healthy volunteers
NCT07823036
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Inclusion Criteria:
* Ages 3 years and older
Exclusion Criteria:
* Pregnancy or positive pregnancy test * Baseline oximetry at MRI visit of less than 90% on room air or less than 90% on a previously prescribed dosage of oxygen delivered by nasal cannula. In some cases of cardiorespiratory disease, if the participant is referred to this research study by their treating physician and considered stable for imaging, the cardiorespiratory criteria will be 5% of their clinical baseline. This should be documented in the research record upon referral of a participant that meets this scenario. * Any condition in the opinion of the investigator that would make the participant unable to tolerate the MRI procedure (e.g., neurocognitive delay, behavioral issues). * Standard MRI exclusions (e.g., metal, incompatible implants).
DRUG: Hyperpolarized 129 Xenon
HSCT, Respiratory, Gas Exchange Impairment
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Proton MRI of MSK Disorders

In this research study, the investigators want to learn about new ways to use MRI (Magnetic Resonance Imaging) to take clearer pictures of the lungs. The investigators will be using types of MRI called UTE (Ultra Short Echo Time) and bSSFP (balanced Steady-State Free Precession) as well as traditional MRI. The investigators also want to collect images and health information about lungs that are healthy or those in people with different kinds of lung, muscular, and bone diseases. This collection will help us in the future to better understand lung variations in health and disease.

Ashley Borden, MPH - ashley.borden@cchmc.org

ALL
5 years and over
This study is also accepting healthy volunteers
NCT07845708
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Inclusion Criteria:
* Age ≥ 5 years
Exclusion Criteria:
* History of any comorbidity reviewed at the Screening phone call that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject. * Standard MRI exclusion criteria as set forth by the CCHMC Radiology Department and IRC. * Pregnancy
DIAGNOSTIC_TEST: MRI
Muskuloskeletal Diseases, Healthy, Respiratory
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Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis.

The goal of this study is to collect clinical data and samples and to evaluate the feasibility of allogeneic hematopoietic cell transplantation (HCT) in children and young adults with refractory Systemic Juvenile Idiopathic Arthritis (sJIA), including those with sJIA-associated lung disease (sJIA-LD).

Brian Hils - brian.hils@cchmc.org

ALL
Up to 35 years old
This study is NOT accepting healthy volunteers
NCT07845942
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Inclusion Criteria:
* Patients \<35 years of age are eligible, and participants must meet all the following criteria to be eligible for this study: * Diagnosis: Systemic Juvenile Idiopathic Arthritis (sJIA) diagnosed prior to age 16, fulfilling ILAR classification criteria for sJIA or the provisional PRINTO criteria for systemic arthritis. The diagnosis and disease course must be reviewed and confirmed by a pediatric rheumatologist. * Refractory Disease: sJIA that is refractory to standard therapy, defined as meeting at least one of these conditions despite appropriate treatment: * Persistent JIA activity: Ongoing active disease (e.g. uncontrolled arthritis or systemic features such as fever, rash, organ inflammation) or progressive joint damage or liver dysfunction that has not responded to biologic agents (IL-1/IL-6 inhibitors) and conventional therapies, or inability to wean from high-dose corticosteroids (steroid dependence). * Recurrent MAS: Two or more episodes of macrophage activation syndrome within a 2-year period, indicating a failure to control the hyperinflammation with medical management. (MAS is defined by clinical and laboratory criteria such as fever, cytopenias, hyperferritinemia, hemophagocytosis, etc., per standard definitions.) * sJIA-LD: Presence of lung disease related to sJIA, either symptomatic LD (e.g. chronic cough, tachypnea, hypoxemia) or progressive LD on imaging (worsening interstitial changes), meeting clinical/imaging features such as patchy ground-glass opacities, septal and pleural thickening, or clubbing of digits. sJIA-LD should be confirmed by a pulmonologist/radiologist (e.g. HRCT findings).
Exclusion Criteria:
* Uncontrolled Infection: Presence of a severe, uncontrolled infection at time of enrollment (e.g. sepsis, pneumonia not responding to therapy). * Significant Organ Failure: * Cardiac: EF \< 40% * Renal: GFR \< 30 ml/hr * Active Malignancy: Concurrent cancer diagnosis or history of malignant disease requiring active treatment. * Pregnancy or Lactation: Female patients who are pregnant or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test clinical result at screening (pregnancy testing is done as standard of care for all transplant patients).
Refractory Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis Associated Lung Disease
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