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Search Results Within Category "Asthma/Lung Disease"

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39 Study Matches

A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators

The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators. Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study.

Kelly Thornton - Kelly.Thornton@cchmc.org

ALL
12 years and over
This study is NOT accepting healthy volunteers
NCT06504589
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Consent A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian B. Is willing and able to adhere to the study visit schedule and other protocol requirements Demographics A. ≥ 12 years of age at Visit 1 Medical History A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period Disease History A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: * Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT) * Two well-characterized disease-causing pathogenic variants in the CFTR gene or * One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1 C. Does not have a history of lung transplantation Concomitant Medications A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period B. No use of an investigational drug within 90 days prior to and including Visit 1 C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed. D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1 E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1
Cystic Fibrosis
ineligible and/or not taking CFTR modulators, People with CF
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Pulmonary Hypertension Association Registry (PHAR)

The PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S. PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes. PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care.

Jaynee Bartsch - jaynee.bartsch@cchmc.org

ALL
Not specified
This study is NOT accepting healthy volunteers
NCT04071327
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Inclusion Criteria:
* All age groups * Written informed consent * Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease * Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:
* Diagnosis of WSPH Group 2 pulmonary hypertension * Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease * Diagnosis of WSPH Group 5 pulmonary hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
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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 - 0livia.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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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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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

- cancer@cchmc.org

ALL
Up to 50 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05235165
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Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment. * Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size. * Note: Patient must have eligibility confirmed by rapid central imaging review. * Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon. * Patients must have a histological diagnosis of osteosarcoma. * Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease. * Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery. * Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation. * Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor. * Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi). * Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion. * Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team. * Patients with evidence of extrapulmonary metastatic disease. * Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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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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