This studyis designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.
The purpose of this research is to evaluate if including the investigational Nodify XL2 test results in the decision-making process when planning the management of lung nodules will reduce the number of unnecessary surgical and biopsy procedures. The general study procedures include obtaining blood samples for Nodify XL2 tests, collecting relevant medical information (including test results ordered by your doctor in the management of your lung nodule), and documenting your doctor's recommendations for the treatment of your lung nodule. Participation in this research study may last up to 18 months.
The main objective of this study is to analyze sputum collected from the residue remaining from bronchoalveolar lavage (BAL) procedures to compare the cellular characteristics of BAL samples to those of sputum samples collected from the acapella® airway assist device. We intend to enroll volunteers who are being evaluated by an MUSC pulmonologist as part of their standard medical care. The Control Sputum sample will be collected by volunteers at home over a three day period using an acapella® airway assist device. The cellular profiles of the BAL and sputum samples will be analyzed by flow cytometry. Active participation in this study is expected to last less than one month and will be complete once a sample is obtained from the BAL procedure.
BLUE CORAL is an observational, biorepository study for patients who are hospitalized with COVID-19. The study collects various data and biospecimens, such as blood, urine, and tracheal aspirates, during the patient's hospital stay. The data and biospecimens collected will be used to provide greater knowledge on the biology and epidemiology of COVID-19.
Alpha-1 Antitrypsin (AAT) is a naturally occurring protein involved in the protection of lungs from inflammation. A mutation in the AAT gene (a change in the body's genetic instructions on how to make AAT) causes it to be made incorrectly and very little of it gets into the bloodstream. Severe AAT deficiency (lack of AAT in the blood) causes emphysema, which causes holes in the lungs. This study is being done to learn more about the safety and effectiveness of VX-864 in patients with Alpha-1 Antitrypsin Deficiency.
The treatment period is 28 days with 3 additional follow-up visits. Participants will be randomized to one of 4 groups. Randomized means there is an equal chance of being placed in any of the 4 groups. The groups are placebo (no active drug) or treatment groups 1-3 with varying doses. All groups will take 5 tablets in the morning and 5 tablets at night. The treatment group will take either 100mg, 300mg, or 500mg tablets twice a day. There is an 80% chance of being assigned to a treatment group and a 20% chance of being assigned to placebo.
The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. The SIMPLIFY studyl consists of two similar studies conducted within the same protocol that are being done to answer the following questions:
• Study A: For people with CF taking Trikafta, does stopping treatment with hypertonic saline (at least 3%) have a similar effect on lung function as continuing treatment with hypertonic saline?
• Study B: For people with CF taking Trikafta, does stopping treatment with Pulmozyme have a similar effect on lung function as continuing treatment with Pulmozyme?
There are a total of 4 study visits (a screening visit and three additional visits during the active part of the study). There is a 2-week screening period and a 6-week active study period.About 920 people with CF who are 12 years of age or older will take part in this study at approximately 80 hospitals and clinics around the country. Of this total, approximately 520 people will participate in the hypertonic saline (Study A) portion and 400 people with participate in the Pulmozyme (Study B) portion of the study.
This clinical study is testing the safety (if there are side effects) and tolerability of CB-280 in approximately 32 subjects with CF. This study is being conducted to indentify which CB-280 doses are safe to take without causing too many side effects. CB-280 is an investigational drug that is taken by mouth that blocks an enzyme called arginase, which is thought to play an important role in promoting lung infection in cystic fibrosis (CF). Participation in the study will be up to 56 days long.
This study is for patients that have been diagnosed with non-squamous non-small cell lung cancer. The purpose of this study is to evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with Stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. The investigational drugs used in this study are talazoparib and avelumab. Talazoparib and avelumab are drugs that may increase the ability of your immune system to fight lung cancer. Participants can expect to be on this study until disease progression, the side effects come to severe or they choose to discontinue the study. Participants will be followed by the study doctor for up to 3 years.
This observational research study will collect safety information from subjects who received study treatment (lenabasum or placebo) in a Corbus-sponsored pivotal clinical trial. This is being done to understand how stopping the study treatment affects the subject, and to make sure that the subject is not experiencing any side effects from stopping the study treatment. The subject will not be given any investigational drugs, including lenabasum or a placebo, in this study. The subject will be assessed (by telephone or office visit) approximately every 6 months for up to 2 years from the time of the last safety visit in a pivotal trial, unless Corbus stops studying lenabasum or decides to stop the study itself. The number of potential phone calls will depend on when the subject joins the study, but will not exceed 5 total. Approximately 100 subjects are expected to take part in this study in North America, Europe, and Asia-Pacific (APAC).
This study is for patients who have RET Fusion-Positive Stave IV or Recurrent Non-Small Cell Lung Cancer. The purpose of this study is to see if we can lower the chance of RET Fusion-Positive Advanced Non-Small Cell Lung Cancer growing or spreading by using the study drug selpercatinib (LOXO-292). Selpercatinib (LOXO-292) is a drug that inhibits RET, a biomarker present in your tumor. Participants will be on this study until disease progression, the side effects become too severe or until they choose to discontinue the study. Participants will be followed by the study doctor for up to 3 years.