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 goal of this research study is to find out if intramuscular sternocleidomastoid (SCM) steroid injections work to reduce cough when compared to superior laryngeal nerve (SLN) steroid injection. Study patients will be randomly assigned to receive injections to numb the sensation within the voice box in one of two possible locations, either a traditional voice box injection or an injection into the neck muscle (a muscle in the neck near the voice box). The injections are composed of a numbing medication (lidocaine) and a medication that helps the numbing medication work longer (steroid). The outcomes studied will include if the treatments help to minimize chronic cough and associated symptoms. By better understanding if this treatment helps improve chronic cough, an additional treatment option could help patients with chronic cough. Voice box injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT training). However, if neck muscle injections are found to be equivalent in treating chronic cough, general ENT doctors could likely provide this treatment to their patients without the need to see a specialized voice box doctor.
This is Phase 2, 2-part, placebo-controlled study to evaluate the efficacy of the oral medication Difelikefalin at 3 different dose levels (0.25 mg, 1 mg, 2 mg BID) for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica. Study participants will participate in Part A or Part B of the study. If you are eligible to take part in this study, you will be randomly assigned to one of 4 study treatment arms during Part A of the study.
• Arm 1: Difelikefalin 0.25 mg
• Arm 2: Difelikefalin 1 mg
• Arm 3: Difelikefalin 2 mg
• Arm 4: placebo
Participants enrolling in Part B will be randomized in a 1:1 ratio receiving either Difelikefalin or placebo. The dose of Difelikefalin will be determined by the results of Part A. The duration of Blinded Treatment: Part A: 8 weeks, Part B: 8 weeks. A 52 week Open-label extension (OLE) is available for participants enrolling in Part B. During the OLE, participants. Difelikefalin will be administered in the same dose as Part B.
This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.
This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.
Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.
Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.
Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.
In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.
It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.
Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.
The purpose of this double-blind, randomized, study is to obtain information on the safety and impact on respiratory function of 150 ppm nitric oxide (NO), given in addition to the standard of care of patients with viral community-acquired pneumonia. The trial is comprised of a treatment period of up to 7 days and follow-up to 180 days post-baseline. Subjects will be randomized 1:1 to receive Treatment or Control. Inhalation treatments will be delivered using LungFit® PRO every 4.5 hours (±30 min). The treatment schedule must be stopped during the night for a recess of at least 7 hours (but not more than 12 hours) in order to ensure the subject's well-being and time to sleep (preferably between 24:00-7:00). This recess will not affect the number of inhalations given in a 24-hour period (4 inhalations in 24 hours).
The study will aim to link data collected during the DELIVER Randomized Contolled Trial (RCT) to Real World Data (RWD) during the 10 year period following subject participation in the clinical trial. Only individuals who participated in the DELIVER clinical trial will be approached to participate in this research. The study team will need to collect some of the subject's personal health identifiers. A research team at Brigham and Women's Hospital, the coordinating center for the DELIVER Trial, will then use the subject's personal identifiers to obtain data from subjects' health insurance and/or hospital systems.
Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of donor derived mesenchymal stem cells to relieve chronic pain. After cell infusion into the vein, the participant will be followed for 6 months to evaluate their pain and other outcomes. There are a total of 5 clinic visits with a total study participation of up to 7 months.
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.
The purpose of this registry study is to gather more information to answer research questions about upper tract urothelial carcinoma (UTUC) and the use of Jelmyto as a treatment. Jelmyto is not an experimental medication. It has been approved by the Food and Drug Administration (FDA) in the United States for the treatment of low grade UTUC since April 2021. For this study, data will be collected from the medical record including type and location of UTUC, treatments and surgeries received, and health status following treatments and surgeries. Approximately 400 people will participate in this study. Participation in this study will last three (3) years.
Patients who previously had been treated with either intravenous ganciclovir or oral
valganciclovir as an infant or toddler, either as part of a previous Collaborative Antiviral Study Group (CASG) study or through routine clinical care at a current or former CASG study site, will be offered enrollment on this retrospective follow-up study.