This study is for people with low-risk HER-2 positive breast cancer. The study is being done to see if treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients who have had surgery, chemotherapy, and HER2-targeted therapy.
The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.
This study is for people with non-small cell lung cancer that has come back or grown after receiving immunotherapy treatment. This study is being done to see if a new combination of 2 non-chemotherapy drugs will help patients live longer than the usual approach.
This study is for patients who have advanced non-small cell lung cancer who in addition to the EGFR gene change (mutation) that was previously found in their tumor, testing found that their tumor also now has MET gene changes. The study is checking to see if a combination of 3 targeted drugs work together to lower the chance of lung cancer growing or spreading.
This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung
Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.
This is a randomized, double-blind, dose-ranging, placebo-controlled study to see how effectively and how safely two different doses of bexotegrast (160 and 320 mg) can be taken every day for 52 weeks (about 12 months) by subjects with IPF (Idiopathic Pulmonary Fibrosis) who are taking or not taking background therapy (other drugs for IPF include nintedanib or pirfenidone). The study is designed to test the study drug in subjects who are taking or not taking background therapy and will include about 80 subjects who are not taking background therapy at study entry. Subjects who are not taking background therapy at study entry will be allowed to start it at any time during the study. The study will consist of an up to 28-day Screening Period, a 52-week Treatment Period, and a 14-day Safety Follow-up Period. Participants will undergo an end-of-study visit at the end of the Safety Follow-up Period.
This research is all about investigating a potential treatment for a specific type of advanced lung cancer. The cancer cells have a protein called c-Met that's acting a bit too excited, driving the cancer to spread and resist treatment. This study focuses on two treatments: one is called Telisotuzumab Vedotin (ABBV-399), which is a smart combination of an antibody and a drug that can stop this protein's activity. The other treatment is called Docetaxel. The researchers have already found in smaller studies that Telisotuzumab Vedotin could be promising for this type of cancer, especially in patients whose previous treatments didn't work well. Now they want to see if it can really make a difference in the long run. They'll be comparing Telisotuzumab Vedotin and Docetaxel to figure out which one is better at helping patients live longer without their cancer getting worse. In this study, participants will be randomly divided into two groups, like flipping a coin. One group will get a new medicine called telisotuzumab vedotin through a vein in their arm every two weeks. The other group will receive a treatment called docetaxel through a vein every three weeks. People in both groups will keep getting their assigned treatment until their doctors say it's time to stop based on certain criteria. Throughout the study, participants will have scans like X-rays or MRIs to see how their tumors are doing. These scans will happen at the beginning and then every few weeks for the first year, and less often as time goes on.Even if someone stops their treatment for a reason other than their cancer getting worse on these scans, the researchers will keep track of them until their cancer gets worse or until they decide they don't want to be in the study anymore.The whole study is expected to last around 38 months, which is a little over 3 years. They'll keep following up with the participants, either by talking to them, checking their medical records, or other appropriate methods, until the participants decide to leave the study or pass away. This study is a big step towards finding better options for people battling this tough form of lung cancer.
The purpose of the study is to evaluate the safety and how well the medication levosimenden works versus placebo in treating Pulmonary Hypertension and Heart Failure with a Preserved Ejection Fraction measured by a 6 minute walk. This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Levosimendan is a drug that has been FDA-approved for intravenous (IV) delivery to your body. This study aims to determine if the tablet form of the drug is as effective as the IV route. Tablets are much more attainable for patients to manage their heart failure from home, rather than going to an infusion clinic for treatments. Participation in this study will last approximately 12 weeks with the option to continue to the stage 2 phase of the study. If the stage 2 phase is selected as well, participation will last approximately 26 months or a little over 2 years. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks.
Participants will be randomized to either the treatment group (and receive the medication) or the control group (receive an inactive medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.
This study involves research, and participation is voluntary. The purpose of the study is to see if a single dose and multiple doses of the study drug, AV 380, are safe and tolerated in cancer participants. This study will also help to look at how AV 380 behaves inside the human body (called pharmacokinetics), how the body responds to AV 380 (called pharmacodynamics), and how the immune system responds to AV 380 (called immunogenicity) when administered along with the standard anticancer treatment that a participant would usually receive if they were not in this study. First, the participant will have some tests to decide if it is safe for to join the study. These tests include blood and urine sampling, electrocardiogram, vital sign measurement, physical examination, cachexia assessment,which checks changes in proteins that affect appetite and computed tomography (CT) scan. If the study doctor thinks a participant is eligible to join, they will be assigned to one of 5 cohorts (a group of people with shared characteristics) (corresponding to 5 dose levels of AV 380) in which then they will receive AV 380 together with the Standard of Care treatment chemotherapy. Participants will need to visit the study site approximately every 1 week for the first 8 weeks and then every 2 weeks. In addition to the above-mentioned tests, then they will be also asked to have exercise tests and complete questionnaires during the study. Participants will also have post study treatment follow up visits 3 times after completion or discontinuation of AV 380. The total duration of the study is up to 7 months (including follow-up visits). Some reasonably foreseeable risks or discomforts with this study include chills, headache, and elevations in an enzyme called creatine phosphokinase which is found mainly in the heart, brain, and skeletal muscle. There is no direct benefit with participating in this study, but the information we get from this study will us improve treatment for people in the future.