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Search Results Within Category "Breathing, Lung & Sleep Health"

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20 Study Matches

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry (IPF/ILD-PRO)

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Hyun Kim
All
30 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01915511
1408M52921
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Inclusion Criteria:

• Willing and able to provide informed consent
• Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
• Age 30 years or older, or
• Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype
Exclusion Criteria:

• Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• Currently listed for lung transplantation at the time of enrollment
• Currently enrolled in a clinical trial at the time of enrollment in this registry
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Idiopathic pulmonary fibrosis, Pulmonary fibrosis, IPF, Registry, 1199.174, Interstitial Lung Disease, ILD, Interstitial Lung Disease with Progressive Phenotype, Clinics and Surgery Center (CSC)
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Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation

The primary objective of the study is to assess the efficacy of patient controlled sedation (Self-management of sedative therapy) using dexmedetomidine to reduce anxiety, delirium incidence and duration of mechanical ventilation compared to usual sedation practices in mechanically ventilated subjects.

Craig Weinert
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02819141
1605M88241
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Inclusion Criteria:

• Subject is acutely mechanically ventilated during the current hospitalization.
• Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
• Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
• Subject Age ≥ 18 years
• Subject or their proxy is capable of providing informed consent
Exclusion Criteria:

• Aggressive ventilatory support or prone ventilation.
• Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded.
• Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
• Paralysis or other condition preventing the use of push button device
• Positive pregnancy test or lactation
• Acute hepatitis or liver failure (direct bilirubin >5 mg/dL)
• Acute stroke or uncontrolled seizures.
• Acute myocardial infarction within 48 hours prior to enrollment.
• Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)
• Assessed RASS -3, -4, -5 or RASS +2,+3, +4
• Chronic ventilator support in place of residence prior to current hospitalization.
• Imminent extubation from mechanical ventilator support.
Drug: Dexmedetomidine
Critical Illness, Anxiety, Respiratory Failure
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Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI) (FURI)

The purpose of this study is to see how well the experimental drug, SCY-078, works at treating people with fungal diseases that are resistant to, or unable to be treated due to bad side effects of, the Standard Antifungal Treatment that is currently used by doctors. This study will compare the effects of SCY-078 to Standard Antifungal Treatment.

Jo-Anne Young, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03059992
STUDY00000611
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Key
Inclusion Criteria:

• Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment
• Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube
• Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
• Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).
• Be able to understand and follow all study-related procedures including study drug administration.
• Agree to use a medically acceptable method of contraception while receiving protocol-assigned product. Key
Exclusion Criteria:

• An invasive fungal disease with CNS involvement.
• Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).
• Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.
• A life expectancy < 30 days.
• Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >10 x the upper limit of normal (ULN), and/or total bilirubin > 5 x ULN.
• Subject is pregnant or lactating.
• Subject has used an investigational drug within 30 days prior to the baseline visit.
Drug: Ibrexafungerp
Invasive Candidiasis, Mucocutaneous Candidiasis, Coccidioidomycosis, Histoplasmosis, Blastomycosis, Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis, Invasive Pulmonary Aspergillosis, Recurrent Vulvovaginal Candidiasis, Other Emerging Fungi
Clinics and Surgery Center (CSC)
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Pulmonary Fibrosis Foundation Patient Registry (PFFR) (PFFR)

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. Participants will be asked to complete patient reported outcome (PRO) surveys related to ILD symptoms and quality of life at the time of enrollment and during clinical follow-up visits (Appendix A – PRO Questionnaires). Each patient will donate approximately 30 mL of blood to the Biorepository, which will be separated into plasma, serum, RNA, and DNA.

Hyun Kim
All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02758808
1605M87921
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Inclusion Criteria:

• 18 years old or older
• Understand and sign the informed consent document
• ILD Diagnosis must be made / confirmed at a participating Registry center.
• The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest.
• If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
• Anticipated additional follow up at the Registry center within one year.
Exclusion Criteria:

• Diagnosed with:
• Sarcoid
• Lymphangioleiomyomatosis (LAM)
• Pulmonary alveolar proteinosis (PAP)
• Cystic fibrosis (CF)
• Amyloidosis
Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
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Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) (PRESERVE)

Primary objective is to evaluate the safety and effectiveness of participating inferior vena cava (IVC) filters in subjects with clinical need for mechanical prophylaxis of pulminary embolism (PE).

Michael Rosenberg
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02381509
1609M94581
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Inclusion Criteria:

• Male or Female, age 18 years or older;
• Requires IVC filter for prevention of pulmonary embolism (PE);
• Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
• Willing to comply with the specified follow-up
Exclusion Criteria:

• Subject is unable to participate in study evaluations pre- and post-treatment
• Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms
Device: IVC Filter
Pulmonary Embolism, Deep Vein Thrombosis
inferior vena cava filters
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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Stephen Huddleston
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03639025
STUDY00003837
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This is an all-comers registry that will enroll all:
• Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
• Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
• All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories:
• TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Device: OCS Lung System
Lung Transplantation
Clinics and Surgery Center (CSC)
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Sleep SMART: Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Investigator-initiated, phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.

Kamakshi Lakshminarayan
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03812653
STUDY00006842
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Inclusion Criteria:

• TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.
Exclusion Criteria:

• pre-event inability to perform all of own basic ADLs
• unable to obtain informed consent from subject or legally authorized representative
• incarcerated
• known pregnancy
• current mechanical ventilation (can enroll later if this resolves) or tracheostomy
• current use of positive airway pressure, or use within one month prior to stroke
• anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
• severe bullous lung disease
• history of prior spontaneous pneumothorax or current pneumothorax
• hypotension requiring current treatment with pressors (can enroll later if this resolves)
• other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
• massive epistaxis or previous history of massive epistaxis
• cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
• recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
• current receipt of oxygen supplementation >4 liters per minute
• current contact, droplet, respiratory/airborne precautions
Device: CPAP
Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, TIA, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial
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An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertension with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

This is an open-label rollover study to continue treatment Levosimendan of subjects who were participated in the Tenax sponsored study after they have completed the 04 parent study.

Thenappan Thenappan
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03624010
STUDY00006731
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Inclusion Criteria:

• Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
• Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
• May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
• Female patients of childbearing potential must agree to use a highly effective method of contraception.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:

• Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
• Pregnant or breastfeeding women.
• Local access to commercially available levosimendan
• Inability to comply with planned study procedures
• Patients with scheduled lung or heart transplant or cardiac surgery
• Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
• Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
• Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
• Weight >150kg
• Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
• Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
• Hemoglobin < 80 g/L
• Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management
Drug: Levosimendan 2.5 mg/ml Injectable Solution
Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
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A Partially-Blind, Randomized, Parallel-Group Dose Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFactTM (Aerosolized SF-RI 1) Administered by nCPAP versus nCPAP alone in the Treatment of Preterm Infants at Risk for Worsening Respiratory Distress Syndrome

A Partially-Blind, Randomized, Controlled, Parallel-Group Dose Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFactTM (SF-RI 1 surfactant for inhalation combined with a dedicated drug delivery system) in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome. To determine an optimal dose of AeroFact™ administered to preterm infants on nCPAP or nIMV vs. nCPAP or nIMV alone in reducing the incidence of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth. To evaluate pulmonary outcomes and respiratory resource utilization at 3, 6, 9, and 12 months PMA

Catherine Bendel
All
26 Weeks to 31 Weeks old
Phase 2
This study is NOT accepting healthy volunteers
NCT03969992
STUDY00007630
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Inclusion Criteria:

• Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
• 26 0/7 to 30 6/7 weeks of gestational age
• Weight <2.0 Kg
• Respiratory Severity Score (RSS) 1.4-2.0
Exclusion Criteria:

• Apgar score less than or equal to 5 at five minutes after birth
• Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
• Premature rupture of membranes (PROM) > 14 days
• Need for intubation and/or mechanical ventilation prior to enrollment
• Active pneumothorax requiring chest tube
• Significant congenital anomaly, chromosomal abnormality
• Concomitant treatments with inhaled nitric oxide
Drug: AeroFact, Other: nCPAP
Respiratory Distress Syndrome in Premature Infant
Respiratory Distress Syndrome, BPD, surfactant, Preterm Infant
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Pulmonary Hypertension Association Registry (PHAR) (PHAR)

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. The goals of the PHAR include 1) measuring and improving quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes), 2) determining the clinical effectiveness, comparative effectiveness, and cost effectiveness of treatment approaches, 3) understanding risk factors for outcomes and regional/center differences, and 4) facilitating funded clinical trials of new therapies and collaboration with the PAH community at large, including providers, patients, and their caregivers.

Thenappan Thenappan
All
Not specified
Clinical Outcomes Research
This study is NOT accepting healthy volunteers
NCT04071327
1702M07281
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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
Clinics and Surgery Center (CSC)
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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care / (POPS): NICHD-2019-POP02 (including COVID-19 drugs) (POPS or POP02)

The majority of drugs administered to children are used off label, and PK studies to define appropriate dosing are lacking across pediatric age groups and special populations of children. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard-of-care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per SOC as prescribed by their treating provider. This study will serve as a tool to better understand drug exposure in children receiving drugs per SOC. The data collected through this initiative will provide valuable PK and dosing information for drugs in different pediatric age groups as well as special populations of children, such as premature infants, critically ill children receiving ECMO or CRRT, children with Down syndrome and children with obesity, for which dosing may vary due to altered PK. In addition, the data collected in this study will serve as preliminary data to design and plan the best and most efficacious BPCA trials, proof-of-concept studies associated with biomarkers, and data to support applications for extramural funding. All of the drugs studied in this protocol are used as standard of care in children and are approved in adults. There will be multiple INDs held by the core study Principal Investigator: Danny Benjamin, MD, PhD (IND Sponsor) Kiser-Arena Distinguished Professor of Pediatrics, Duke University Faculty Associate Director, Duke Clinical Research Institute PO Box 17969 Durham NC 27715 Phone: 919-668-8295 Fax: 919-681-9457 danny.benjamin@duke.edu The Funding Sponsor is The National Institute of Child Health and Human Development (NICHD) NOTE: We will be participating in the COVID 19 arm of this study, which includes 6 drugs of interest (DOI). All other arms are on hold currently; and focus has been placed on the COVID 19 arm. However, in the future we may be interested in participating in other DOIs. The details of this arm of the study will be provided at the end of this document. (See Appendix P, pages 82-86 of main protocol)

Catherine Bendel
All
up to 20 Years old
NA
This study is NOT accepting healthy volunteers
NCT04278404
STUDY00009884
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Inclusion Criteria:

• Participant is < 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:

• Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
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Phase II Randomized, Intervention Versus Non-Intervention, Multi-Center Study of the Effects of Thyroid Hormone (T3) on Extravascular Lung Water (EVLW) in Subjects with Acute Respiratory Distress Syndrome (ARDS) (ARDS+T3)

Study objective: To determine the safety and tolerability of Thyroid Hormone (T3) delivery into the lungs of Acute Respiratory Distress Syndrome (ARDS) patients, and to measure the effect of T3 on extravascular lung water in ARDS patients.

Ronald Reilkoff
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04115514
STUDY00007410
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Inclusion Criteria:
Clinical diagnosis of ARDS:
• Chest x-ray: bilateral pulmonary infiltrates
• Hypoxemia: PaO2:FIO2 ratio <200
• Volume status: wedge and CVP<18 Main inclusion criteria:
• Adults (≥18 years of age), non-pregnant
• On mechanical ventilatory support
Exclusion Criteria:

• Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub-Investigators.
• Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub-Investigators or hospice status.
• Active drug/alcohol use with positive drug screen or alcohol level on admission.
• Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
• Prior history of cardiovascular disease including:
• Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg),
• Sustained ventricular arrhythmia in the past 3 months (duration > 30 seconds)
• Coronary artery disease (documented >50% occlusion in any coronary vessel)
• Cardiac-related angina pectoris (> 2 episodes in the past 3 months)
• Myocardial infarction with ischemia on ECG (i.e., new ST-elevation/depression of >1mm in contiguous leads), or positive cardiac enzymes (Ratio of CK-MB: Total CK > 3.5).
• Peripheral vascular disease (documented >50% occlusion in any peripheral vessel).
• Moderate or severe ischemic/non-ischemic cardiomyopathy (documented ejection fraction < 40%).
• Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
• Currently pregnant or breastfeeding.
• Currently taking tricyclic antidepressants, glycosides, ketamine, or vasopressors with ongoing evidence of myocardial ischemia.
• Known allergy to study drug.
Drug: Liothyronine Sodium (T3) (modified formulation)
ARDS, Human, Lung, Wet, Thyroid, Pulmonary Edema, Lung Inflammation
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Pulmonary Hemodynamics During Exercise - Research Network (PEX-NET)

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03954574
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Inclusion Criteria:

• Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
• Written informed consent of participating subjects after being fully briefed (for prospective analysis)
Exclusion Criteria:

• Patients with incomplete hemodynamic data at rest or exercise
• Patients without sufficient follow-up data (information on survival / lung transplantation)
• advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
• advanced heart failure with pulmonary arterial wedge pressure (PAWP) > 18 mmHg at rest
• uncontrolled systemic arterial hypertension (RR values > 160/100 mmHg at rest)
• FEV1<50% predicted
• TLC<60% predicted
Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
Pulmonary Circulation Diseases
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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) (FLASH)

FLASH is a post-market, prospective data collection registry. The intention of this registry is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. The study involves no intervention and all medical procedures are standard of care and not research. The device is FDA approved and being used according to the instructions for use and the physician's discretion.

Michael Rosenberg
All
18 Years and over
Phase IV
This study is NOT accepting healthy volunteers
NCT03761173
STUDY00008046
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Inclusion Criteria:

• Clinical signs and symptoms consistent with acute PE
• Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
• Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*
• US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
Exclusion Criteria:

• Unable to be anticoagulated with heparin or alternative
• Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
• Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*
• Life expectancy < 30 days, as determined by Investigator
• Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
• US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
Device: FlowTriever System, Drug: Anticoagulation Agents
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication
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A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE)

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study including patients with IPF. The combination of PRM-151 with standard of care pirfenidone or nintedanib for 52 weeks will be evaluated, with primary objective as the absolute change from baseline to Week 52 in forced vital capacity (FVC).

Hyun Kim
All
40 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04552899
STUDY00011372
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Inclusion Criteria:

• Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline
• High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
• Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test (6MWT) during screening
• FVC >/= 45% predicted during screening as determined by the over-reader
• Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader
• Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to ( • If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening
• If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment >/= 4 weeks prior to screening and during screening
• Anticipated life expectancy of at least 12 months at baseline
• Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
• For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
• Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
• For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Exclusion Criteria:

• Evidence of other known causes of Interstitial Lung Disease (ILD)
• FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value
• Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
• Receiving nintedanib in combination with pirfenidone
• Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening
• Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during screening
• Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
• Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])
• Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level) during screening
• Class IV New York Heart Association chronic heart failure
• Historical evidence of left ventricular ejection fraction < 35%
• Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
• Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial
• History of smoking, alcohol or substance abuse disorder, or a malignancy
• Previous treatment with PRM-151
• Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula
• Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant
• Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151
• Women of childbearing potential (Only for participants enrolling in Japan)
Drug: PRM-151 (Zinpentraxin Alfa), Drug: Placebo
Idiopathic Pulmonary Fibrosis
Clinics and Surgery Center (CSC)
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An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Pulmonary Arterial Hypertension

This pilot clinical trial will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials in treatment of PAH. Active drug in capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors will be administered to patients with PAH. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment and pharmacodynamics in terms of potential mechanisms. It will also allow for limited evaluation of cardiac endurance and function prior to and after IMT.

Thenappan Thenappan
All
18 Years to 75 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04884971
STUDY00012951
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Inclusion Criteria:

• Diagnosis of pulmonary arterial hypertension (PAH)
• On stable treatment for PAH for one month prior to enrollment
• Able to swallow capsultes
• Able to provide blood sample and fecal sample
Exclusion Criteria:

• Dysphagia to pills
• Clinically active inflammatory bowel disease
• Pregnancy or breastfeeding
• Life expectancy of <6 months
• Presence of ileostomy or colostomy
• Taking immunosuppressants (calcineurin inhibitors, prednisone greater than or equal to 20mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
• Neurotropenia (an absolute neurotrophil count < 0.5 x 10^9 cells/L)
• History of solid organ or bone marrow transplant
• Anticipated recurrent antibiotic use (participants with frequent urinary tract infections or sinusitis)
• History of severe anaphylactic food allergy
• History of celiac disease
• History of receiving cancer chemotherapy, immunotherapy, or radiation
Drug: Intestinal microbiota transplant (IMT)
Pulmonary Arterial Hypertension
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background P AH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

Thenappan Thenappan
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04576988
STUDY00012824
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Key
Inclusion Criteria:

• Age ≥ 18 years
• Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:
• Idiopathic PAH
• Heritable PAH
• Drug/toxin-induced PAH
• PAH associated with connective tissue disease
• PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
• Symptomatic PAH classified as WHO Functional Class II or III
• Baseline RHC performed during the Screening Period documenting a minimum pulmonary vascular resistance (PVR) of ≥ 5 Wood units (WU) and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg.
• On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice.
• 6MWD ≥ 150 and ≤ 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value)
• Females of childbearing potential must:
• Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; she must agree to ongoing urine or serum pregnancy testing during the study and until 8 weeks after the last dose of the study drug
• If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment
• Refrain from breastfeeding a child or 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 treatment
• Male participants must:
• Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
• Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
• Ability to adhere to study visit schedule and understand and comply with all protocol requirements
• Ability to understand and provide written informed consent Key
Exclusion Criteria:

• Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
• Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension. Exclusions in PAH Group I should also include schistosomiasis APAH and pulmonary veno occlusive disease
• Hemoglobin (Hgb) at screening above gender-specific upper limit of normal (ULN), per local laboratory test
• Baseline platelet count < 50,000/mm3 (< 50.0 x 109/L) at screening
• Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during screening visit after a period of rest
• Baseline systolic BP < 90 mmHg at screening
• Pregnant or breastfeeding women
• Any of the following clinical laboratory values at the screening visit:
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/m2 (as defined by MDRD equation)
• Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels > 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome)
• Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
• Prior exposure to sotatercept (ACE-011) or luspatercept (ACE 536) and/or excipients or known allergic reaction to either one
• Have full or partial pneumonectomy
• Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit. If PFT is not available, a chest CT scan showing more than mild interstitial lung disease (ILD) performed at the screening visit or 1 year prior to it.
• Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the screening visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
• History of more than mild obstructive sleep apnea that is untreated
• Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
• History of restrictive, constrictive or congestive cardiomyopathy
• History of atrial septostomy within 180 days prior to the screening visit
• Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the screening period
• Personal or family history of long QT syndrome (LQTS) or sudden cardiac death
• Left ventricular ejection fraction < 45% on historical echocardiogram within 6 months prior to the screening visit
• Any symptomatic coronary disease events within 6 months (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months of the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.
• Cerebrovascular accident within 3 months prior to the screening visit
• Acutely decompensated heart failure within 30 days prior to the screening visit, as per investigator assessment
• Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
• Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
Drug: Sotatercept, Drug: Placebo
Pulmonary Arterial Hypertension
Pulmonary, Hypertension, sotatercept, Clinics and Surgery Center (CSC)
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A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) (PERFECT)

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6MWD following 12 weeks of active treatment in subjects with PH-COPD.

Thenappan Thenappan
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03496623
STUDY00012487
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Inclusion Criteria:
Participants who meet the following criteria may be included in the study:
• Participant voluntarily gives informed consent to participate in the study.
• Males and females 18 years of age and above at the time of informed consent.
• Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, [<1% per year], such as approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug. Participants must have a negative pregnancy test at the Screening Visit 1 (urine [prior to the first dose of study medication] and serum) and Baseline Visit (Study Week 1) (urine).
• Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.
• Diagnosis of PH-COPD (World Heath Organization [WHO] Group 3).
• Clinical diagnosis of COPD will be made using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria (GOLD Criteria 2020) and spirometry with the following documented parameters measured during Screening Visit 1 (prior to start of low-dose inhaled treprostinil):
• Forced expiratory volume in 1 second (FEV1) <80% predicted
• FEV1/Forced vital capacity (FVC) <70
• The participant has a resting saturation peripheral capillary oxygenation (SpO2) greater than or equal to 90%, with or without supplemental oxygen, but not to exceed 10 liters (L)/min oxygen supplementation by any mode of delivery during Screening Visit 1.
• During Screening Visit 1 prior to start of low-dose inhaled treprostinil, a 6MWD greater than or equal to 100 meters.
• Have a right heart catheterization (RHC) performed during Screening Visit 1. (A previous RHC obtained within 12 months prior to the start of Screening Visit 1 is acceptable for determining eligibility, even if done without oxygen or vasodilator challenge, and a repeat RHC is not required.) The following parameters must be documented for eligibility:
• Pulmonary vascular resistance (PVR) greater than or equal to 4 Wood units
• A pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure (LVEDP) of less than or equal to 15 millimeters of mercury (mmHg)
• A Pulmonary artery pressure mean (PAPm) of greater than or equal to 30 mmHg
• Participants must be on a stable and optimized dose of chronic COPD medications for greater than or equal to 30 days prior to start of Screening Visit 1 and remain on the same dose throughout the Screening Period.
• In the opinion of the Investigator, the participant can communicate effectively with study personnel and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
Exclusion Criteria:
The following will exclude participants from the study:
• The participant has a diagnosis of either pulmonary arterial hypertension (PAH) or pulmonary hypertension (PH) due to reasons other than COPD. This would include, but is not limited to, chronic thromboembolic PH or acute/recent deep vein thrombosis or pulmonary embolism, untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma or systemic lupus erythematosus), sarcoidosis, human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
• Based on chest computed tomography (CT) imaging during Screening Visit 1, the participant has a confirmed diagnosis of WHO Group 3 PH, other than COPD, such as idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease or interstitial lung disease. A previous chest CT scan performed within the 6 months prior to the start of Screening Visit 1 is also acceptable, and a repeat assessment is not required. A redacted CT scan report (from Screening Visit 1 or dated within prior 6 months) should be provided to the Medical Monitor with the Pre-Baseline Review Form to confirm eligibility.
• The participant has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (that is, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist [ERA], phosphodiesterase type 5 inhibitor [PDE5-I], or soluble guanylate cyclase [sGC] stimulator) at Screening Visit 1 and thereafter, except if received for acute vasoreactivity testing.
• The participant has a previous diagnosis of homozygous alpha-1 antitrypsin deficiency.
• The participant has any prior intolerance to inhaled prostanoid therapy.
• Inability to tolerate low-dose (3 breaths, 18 mcg) study drug and/or inability to follow dosing regimen during the Screening Period (pre-randomization).
• Unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
• The participant has evidence of clinically significant left-sided heart disease (including but not limited to left ventricular ejection fraction <40%, left ventricular hypertrophy,) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease. Note: Participants with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor Medical Monitor is needed.
• Any exacerbation of COPD (including hospitalization or outpatient therapy) or active pulmonary or upper respiratory infection 60 days prior to start of Screening Visit 1 through the Baseline Visit. This is defined as worsening of respiratory symptoms that required treatment with corticosteroids and/or antibiotics.
• Initiation of pulmonary rehabilitation within 12 weeks prior to start of Screening Visit 1 or, in the opinion of the Investigator, pulmonary rehabilitation is likely to be needed during the study Treatment Period.
• The participant has any form of congenital heart disease (repaired or unrepaired; other than a patent foramen ovale).
• The participant has any musculoskeletal disorder (severe arthritis of the lower limbs which limits ambulation, recent hip or knee joint replacement, artificial leg) or any other condition that would likely be the primary limitation to ambulation.
• Use of any other investigational drug or device within 30 days prior to the start of Screening Visit 1.
• Any other clinically significant illness or abnormal laboratory value(s) measured during the Screening Period that, in the opinion of the Investigator, might adversely affect the interpretation of the study data or safety of the participant.
Drug: Inhaled treprostinil solution, Drug: Placebo solution
Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension, COPD, Inhaled Treprostinil, 6-Minute Walk Test, Tyvaso, Clinics and Surgery Center (CSC)
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STRIKE-PE: A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

The purpose of this study is to collect information on how patients with PE recover after treatment with the Indigo Aspiration System. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head. The device is commercially available globally. Participants will be in this research study for about one year. Participants will be asked to complete a screening and baseline visit, device procedure in-patient visit as part of routine treatment for their PE, one post-procedure visit in the hospital and two follow-up visits. The study team will collect information on tests and procedures done during these visits from their medical records. They will also be asked to complete a quality of life questionnaire.

Michael Rosenberg
Post Market Monitoring
This study is NOT accepting healthy volunteers
NCT04798261
STUDY00013412
Pulmonary Embolism
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Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial (PRECISIONS)

Patients with idiopathic pulmonary fibrosis (IPF) that have the TOLLIP rs3750920 TT genotype will be treated with N-acetyl cysteine (NAC) compared to placebo, while receiving standard care. Standard of care is defined as allowing background therapy with FDA-approved medications for IPF, such as pirfenidone or nintedanib, if taking a stable dose for at least 6 weeks prior to enrollment.

Hyun Kim
All
40 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04300920
STUDY00012926
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Inclusion Criteria:

• ≥ 40 years of age
• Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
• Signed informed consent
• If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
• Confirmed rs3570920 TT TOLLIP genotype
Exclusion Criteria:

• Pregnancy or planning to become pregnant
• Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation
• Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
• Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
• Supplemental or prescribed NAC therapy within 60 days of enrollment
• Listed for lung transplantation at the time of screening
• History of lung cancer
• Inability to perform spirometry
• Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
• Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Drug: N-acetyl cysteine, Drug: Placebo
Idiopathic Pulmonary Fibrosis
IPF, Pulmonary Fibrosis, n-acetylcysteine, NAC, Clinics and Surgery Center (CSC)
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