Clinical Research Directory

Gene Modifiers of Cystic Fibrosis Lung Disease

The purpose of this study is to examine genetic modifiers of the severity of cystic fibrosis lung disease.

Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.

The INSPIRE CHILD-study is a clinical research project focused on understanding lung diseases in children. The study aims to explore how the presence of certain bacteria, immune responses, and inflammatory markers in the lungs are connected to different lung diseases in pediatric patients. Background: Lung diseases in children can have long-lasting effects on their health, not only during childhood but also as they grow into adults. However, the specific causes and mechanisms behind these diseases are not yet fully understood. The INSPIRE CHILD-study is designed to investigate whether children with various lung conditions have distinct differences in the types of bacteria, immune system activity, and inflammation in their lungs. Hypothesis: Different lung diseases in children are hypothesized to be associated with unique patterns of bacteria, immune responses, and inflammation in the lungs By studying these patterns, the investigators hope to gain new insights that could lead to better diagnostic tools and more personalized treatments for children suffering from lung diseases. Children already scheduled to undergo bronchoscopy are included in the study. A small sample of fluid from the lungs is collected, and the sample is analyzed for bacteria, immune markers, and signs of inflammation. This research could pave the way for improved care and treatment for young patients with lung conditions.

Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection

Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression. The outcome of these patients is poor, and treatment is very long. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast majority patients have converted after 6 months of treatment, so a 18 months duration in total. Unfortunately, few data are available for MX, as it is rare in USA, but it is the second NTM isolated in France and concerns an increasing number of patients. As it is uncommon in USA, no clinical studies conducted by the pharmaceutical laboratory will be planned. In a murine model of MX infection, the only drug which decreased the number colony formant units in mice lungs, was amikacin. Until now, amikacin was only available intravenously and used only for patients with very severe disease, because of renal and auditory toxicity. Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery. ARIKAYCE® increases amikacin uptake into alveolar macrophages, a refuge for NTM organisms; allows biofilm penetration; and limits systemic amikacin exposure ARIKAYCE® has already be tested in a randomized study on M. avium complex (MAC) refractory pulmonary infections. In this study, the culture conversion rate in the ARIKAYCE® group was higher than standard regimen group.

Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules

This is a retrospective, multicenter observational study evaluating the clinical value of combining high-resolution (1024×1024 matrix) targeted CT scans with an artificial intelligence (AI) deep learning system to distinguish between benign and malignant pulmonary nodules. By analyzing existing medical records and CT images of adult patients (aged 18 and older) with pulmonary nodules (3-30 mm) who have confirmed diagnoses (via postoperative pathology）, this study aims to assess the diagnostic accuracy and efficiency of the AI system. The study plans to enroll approximately 10,000 cases from three hospitals in Shanghai. The primary goal is to evaluate the AI system's diagnostic performance (such as sensitivity, specificity, and Area Under the ROC Curve) and compare it with the performance of radiologists, ultimately exploring whether this combined approach can provide more accurate clinical diagnoses and reduce unnecessary procedures.

Housing, Environment, And Living Conditions for Transformed Health

This project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach. STUDY 1: The study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease. STUDY 2: The study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.

Pulmonary Involvement in Children With Systemic JIA

This cross-sectional study aims to describe the clinical characteristics of pulmonary involvement in children with systemic juvenile idiopathic arthritis.

Molecular Epidemiology of Acute Respiratory Distress Syndrome (ARDS)

To examine the possible relationship between genetic factors and the acute respiratory distress syndrome (ARDS).

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Acute or chronic cardiac dysfunction could be a contributing factor to swimming-induced pulmonary edema (SIPE). Knowledge on cardiac function in SIPE is limited and recommendations for cardiac evaluation of patients with SIPE are lacking. The present study was designed to assess cardiac function in patients with SIPE and in asymptomatic swimmers.

PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)

In swimming induced pulmonary edema (SIPE), there is a lack of knowledge regarding optimal treatment. The present study was designed to assess the benefit of treatment with positive expiratory pressure device (PEP-device) compared to spontaneous recovery in patients with SIPE without hypoxia in the out-of-hospital environment.

O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)

In swimming induced pulmonary edema (SIPE), there is a lack of knowledge regarding optimal treatment. The present study was designed to assess the benefit of continuous positive airway pressure (CPAP) compared to oxygen as a first line treatment of SIPE in the out-of-hospital environment.

Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study

To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.

American Lung Association (ALA) Lung Health Cohort

The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.

AI-Based Assessment of Chest Diseases on Chest X-ray Imaging Using DenseNet-121 and a CheXpert-Trained Model

Chest X-rays are widely used to detect thoracic and lung conditions, but reviewing high volumes of radiographs can lead to workload strain and variation between interpreters. Artificial intelligence (AI), particularly deep learning neural networks like DenseNet-121, has shown strong potential to assist clinicians with automated image interpretation. However, AI models trained on large international datasets, such as CheXpert, may perform differently across distinct patient populations due to variations in imaging technique, patient demographics, and disease presentation. The primary purpose of this study is to compare the diagnostic accuracy of a DenseNet-121 model trained or fine-tuned on local data against a DenseNet-121 model pretrained on the CheXpert dataset for identifying thoracic pathologies. Both models will evaluate de-identified frontal chest radiographs from adult patients. Model predictions will be compared against a reference standard established by expert radiologist consensus, with discordant findings resolved using chest computed tomography (CT). Findings will evaluate whether local model adaptation improves diagnostic precision and workflow efficiency in clinical settings.

Deep Sedation With Pre-emptive Endotracheal Intubation for Advanced Bronchoscopy Procedures

Bronchoscopy is crucial for diagnosing and treating respiratory diseases and is recommended under sedation. Deep sedation improves patient comfort and procedural efficiency, especially in complex cases, by reducing movement and coughing. However, it carries risks of respiratory depression and airway obstruction, potentially requiring premature termination or urgent intubation. Determining the optimal timing for intubation can be challenging despite proper monitoring. To enhance safety, the investigator has performed bronchoscopy under deep sedation with preemptive intubation for years, sharing this experience with other hospitals. This study aims to evaluate its safety and feasibility through a multicenter prospective observational approach.

SPSIPB vs SAPB for Thoracoscopic Surgery

Video-assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours of the postoperative period. Analgesia management is very important for these patients in the postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after VATS. US-guided serratus anterior plane (SAP) block provides effective analgesia in the thorax's anterior, posterior, and lateral dermatomes. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study in the literature evaluating the efficacy of SPSIPB and SAP block following VATS.

A Study of Mosliciguat in PH-ILD

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency

Adverse drug events (ADE) are common and dangerous in the hospital and following discharge to the ambulatory setting. One cause of ADEs in both settings is medication regimen inappropriateness, including polypharmacy, drug-drug interactions, and medications that are inappropriate or inappropriately dosed given patients' age, renal, and hepatic function. Hospitalization provides a good opportunity to investigate medication appropriateness given new or worsening conditions and available expertise. Inpatient pharmacists are medication experts and often round with medical teams, but they may not always have all the information available at their fingertips to make optimal recommendations regarding medication appropriateness for each patient. Clinical decision support to pharmacists at the point of care has potential to improve the speed, quantity, and quality of medication recommendations to inpatient teams; any subsequent improvements to medication regimen appropriateness have the potential to reduce ADEs in the hospital and after discharge. Specific Aims and Objectives Aim 1: Implement real-time decision support regarding medication regimen appropriateness among pharmacists who round with inpatient medical teams. Aim 2: Determine the effects of this intervention on the number of medication regimen recommendations and time spent per recommendation Aim 3: Evaluate the use and usability of the decision support tool and develop strategies to mitigate barriers and promote facilitators of implementation using mixed methods implementation science approaches.

Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.

A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Data Collection Using Eko Devices in a Clinical Setting

The main objectives of the study are to: train and validate binary classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine correspondence between type/location of adventitious lung sound and type of pulmonary condition.

Alternative Diagnoses in Patients About to Start Empiric Tuberculosis Treatment

This study is being conducted to determine whether in patients who are diagnosed with tuberculosis on a clinical basis (where tuberculosis is not found in the sputum) might have other lung diseases than tuberculosis. Depending on the precise nature of your complaints, additional investigations shall be requested by the study investigators. Possible additional investigations will include laboratory tests on samples of your blood, an additional chest X-ray, lung function testing (where you will have to blow air into a machine, so that your lung capacity is registered), CT-scan, and bronchoscopy. The information obtained through the investigations done in this study will help in the management of your illness and other patients who are diagnosed with tuberculosis on a clinical basis.

Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC

To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .