Pulmonary Embolism

Researchers are evaluating treatments for patients with high-risk pulmonary embolism (PE), a serious condition that requires immediate clot removal in addition to blood thinners. This trial compares two approaches: catheter-directed thrombectomy (CDT), a procedure that directly removes clots using a device, versus standard full-dose systemic thrombolysis, which dissolves clots using medication. The study aims to see if CDT can reduce death rates and serious complications better than the usual treatment, while also improving recovery and quality of life over one year. Participants are randomly assigned to one of two groups. One group receives the CDT procedure, where a catheter is guided through veins to the lungs to extract clots using suction, combined with blood thinners during the procedure. The other group receives full-dose systemic thrombolysis using clot-dissolving drugs such as Alteplase, Urokinase, or Tenecteplase. The study is open-label, meaning both patients and doctors know which treatment is given. Researchers will monitor effects at various points, including day 7, day 30, and up to one year after treatment. During the trial, participants undergo evaluations including clinical and hemodynamic assessments to determine treatment success, monitoring of oxygen levels, length of stay in intensive care and hospital, and quality of life questionnaires over a year. The main measure is a combined rate of death, treatment failure, major bleeding, and stroke at 30 days. Secondary outcomes include survival, bleeding events, oxygen use, and long-term functional recovery. Cost-effectiveness of the treatments will also be analyzed after one year.

Researchers are studying biomarkers from 129Xe gas exchange MRI to understand how they change with different medical interventions. The study focuses on interactions between 129Xe and red blood cells in the lungs. Participants include healthy volunteers and patients with conditions like interstitial lung disease, pulmonary hypertension, acute or chronic pulmonary embolism, anemia, polycythemia, and dyspnea. The study uses hyperpolarized xenon gas inhaled in multiple doses followed by breath holds, alongside oxygen administration. Participants are grouped by treatment: those undergoing transfusion or phlebotomy, patients receiving oxygen for lung-related conditions or healthy volunteers, and those recently diagnosed with acute or chronic pulmonary embolism. Treatments and responses are monitored at baseline and various follow-up points. Participants will undergo MRI scans to measure red blood cell transfer, chemical shifts after oxygen delivery, and changes in red blood cell signal oscillations before and after treatment. The study includes visits up to 3–6 months after interventions to track changes. Researchers also monitor safety and participant adherence throughout the study, which lasts until mid-2028.

Coughing is a common and distressing symptom for people with interstitial lung disease (ILD), affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapy's impact and participants' experiences.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy (SBRT) to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

This clinical investigation is a prospective, single-arm, multicenter post-market study designed to collect clinical data on the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheters. The study aims to confirm the device's performance in removing arterial emboli and thrombi, identify any emerging risks based on factual evidence, and ensure the continued acceptability of its benefit-to-risk ratio. The device is used for patients undergoing surgical treatment for emboli or thrombi removal, with the study sponsored by LeMaitre Vascular, Inc. The study involves using the LeMaitre TufTex OTW Embolectomy Catheter, which is intended for removing emboli and thrombi during embolectomy or thrombectomy. The catheter can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration. The investigation is planned to enroll 112 subjects across four sites in about three countries, with an enrollment period lasting 48 months. Each participant will be followed for one month after the procedure. The total study duration is approximately 56 months, including start-up, recruitment, follow-up, and closure phases. Participants will undergo surgical treatment using the catheter, and researchers will assess technical success defined as less than 30% residual stenosis one month after the procedure. Safety will be monitored during the procedure and follow-up. Additional outcomes measured include clinical success, revision rates, and vessel patency at one month post-procedure. The study includes monitoring for any adverse events to ensure safety and performance. Participation involves one month of follow-up after the surgical procedure to evaluate these outcomes.

Researchers are studying acute pulmonary embolism, a condition where blood clots block lung arteries, to predict possible serious outcomes within 30 days after hospital admission. This observational study collects clinical, laboratory, and CT scan data from patients diagnosed with acute pulmonary embolism. The goal is to develop a predictive tool using these data to identify patients at higher risk of adverse events. Patients diagnosed with pulmonary embolism by CT pulmonary angiography and aged 18 or older are included. Participants are divided into two groups: one to create and assess a prediction model using logistic regression, and the other to validate this model. The model's accuracy is compared to existing risk assessment systems, aiming to improve early identification of patients who may experience complications. During the study, clinical and imaging data, including CT scans and laboratory tests like cardiac troponin I and NT-pro BNP levels, are collected from admission. Researchers monitor outcomes over 7 and 30 days to evaluate the occurrence of adverse events. The study tracks participants' health status to assess the prediction tool's performance and safety throughout the monitoring period.

Researchers are evaluating the use of dapagliflozin to reduce cardiovascular risk in women who have experienced hypertensive pregnancies. This randomized, placebo-controlled trial focuses on patients at high risk for adverse cardiovascular outcomes within five years after delivery. The study is a pilot-scale, single institution investigation aiming to assess the feasibility, acceptability, and effects of dapagliflozin during the postpartum period. Participants will be randomly assigned to one of two groups: one group will receive dapagliflozin 10 mg daily for six months, while the other group will receive a daily placebo for the same duration. During the study, participants will attend four study visits and complete specific activities including daily blood pressure monitoring, weekly weight measurements, laboratory tests, and echocardiograms. After the six-month treatment period, participants will be followed remotely for one month. Throughout the trial, researchers will measure cardiovascular risk reduction scores at the start and after six months of treatment. Secondary outcomes include tracking patient adherence, barriers to adherence, loss to follow-up rates, and screening statistics over a two-year recruitment period. The total participation includes treatment and follow-up visits, with regular assessments to monitor health and gather data for evaluating the study drugs' impact on cardiovascular risk.

Researchers are evaluating the effects of heated humidified high flow nasal cannula (HFNC) oxygen therapy compared to conventional nasal cannula oxygen therapy in patients with gynecologic tumors who are at high risk for post-operative pulmonary complications (PPC). The study focuses on women undergoing gynecological surgery and aims to measure the occurrence of PPC such as postoperative hypoxemia, atelectasis, and pneumonia. Secondary outcomes include improvements in postoperative oxygenation, antibiotic use, length of hospital stay, and any adverse events related to oxygen therapy. Participants are randomly assigned to one of two groups: the HFNC group receives heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery, with oxygen saturation maintained between 92% and 95%. The control group receives conventional nasal cannula oxygen therapy during the same time frame, also maintaining oxygen saturation at 92% to 95%. Both groups have chest CT scans reviewed 36 to 48 hours after surgery. The HFNC device can provide oxygen concentrations ranging from 21% to 100% with heated and humidified gas at 37°C and a maximum flow of 70 liters per minute. During the study, participants will be monitored for postoperative pulmonary complications over seven days after surgery. Researchers will also assess total hospitalization days, oxygen therapy usage, antibiotic use, postoperative oxygenation, and any adverse events within two to seven days post-surgery. The study includes scheduled chest CT scans and continuous oxygen saturation monitoring to track participant outcomes. The study is sponsored by Sichuan Cancer Hospital and Research Institute and is expected to continue until the end of 2025.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CITY-FXI, a drug targeting Factor XI, in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation. This first-in-human, randomized, double-blind, placebo-controlled study aims to better understand how CITY-FXI works in these populations and its potential effects. The trial is sponsored by City Therapeutics and includes participants aged 18 to 60 years. The study consists of two parts: Part A involves single ascending doses of CITY-FXI or placebo given by subcutaneous injection to healthy adults, and Part B includes similar dosing in adults diagnosed with FVL or prothrombin G20210A mutation. Women of childbearing potential in Part B must use highly effective contraception. The doses will be increased in a controlled manner to assess safety and drug behavior. Participants will be monitored for adverse events throughout the study, up to 360 days after dosing. Researchers will measure drug levels in the blood and urine shortly after dosing, and track changes in blood clotting factors and activity over time. Study visits will include physical exams, laboratory tests, and safety assessments to evaluate treatment effects and participant well-being over the follow-up period.

Researchers are conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.