This study is enrolling subjects with advanced solid tumors with the TP53 Y220C alteration in cancer cells. This alteration is a mutation of the tumor that can be found through laboratory tests that use a sample of tissue, blood, or other fluids to check for signs of cancer. This study involves research testing the safety, best dose, side effects and timing of the study drug called PC1486. You will take the study drug, PC14586, in the form of a tablet. If assigned to the combination treatment arm (Part 1), you will also be given pembrolizumab as an intravenous (IV) infusion. Pembrolizumab is a type of immunotherapy that is FDA approved to treat your kind of cancer. The study drug PC1486 is not approved by the Food and Drug Administration (FDA). This study drug targets the TP53 Y220C genetic alteration in tumor cells. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample to test for the genetic alteration. If the participants show the genetic tumor alteration in the cancer cells, they may be asked to participate in the trial. Treatment arms are groups or subgroups of participants in a clinical trial. This study will have two arms: one studies PC1486 alone and the second arm studies PC1486 in combination with Pembrolizumab against advanced solid tumors. PC14586 is a small molecule (chemical) that is designed to act on the genetic alteration TP53 Y220C in cancer cells to slow the growth of cancer, and it is taken orally. This study involves blood tests, a possible tumor biopsy, CT, and MRI scans. The study will last approximately 6 months of treatment, followed up by a check-up after the first 3 weeks and every 3 months after. Some common risks (observed in greater than 20% of people) include: Nausea, Vomiting, Abnormal liver tests, Abnormal kidney test (possible kidney damage
A randomized clinical trial study that compares 2 different timepoints to clamp the cord at birth. The study involves babies with heart disease born between 37 0/7- 41 6/7 weeks of pregnancy. Doctors will clamp the umbilical cord around 30 seconds (between 1-<60 seconds) after birth vs. around 120 seconds (between 60-<180 seconds) after birth. Doctors consider both treatment groups to be "usual care." A goal of this study is to find out which umbilical cord clamping timepoint is best for babies with heart disease.
They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.
This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.
Imagine you're flipping through a medical journal and stumble upon a study about lung cancer treatment. This study is not just any ordinary research; it's focused on a group often overlooked in clinical trials: older adults. The researchers are curious about how well a new treatment, called immunotherapy, works for these older folks who might have other health issues besides cancer. They've noticed that most studies tend to include younger, healthier people, so they want to see if the same treatments work as well for Grandma and Grandpa. They found that immunotherapy, which boosts the body's immune system to fight cancer, can be a game-changer for older adults with lung cancer. But here's the twist: they're not sure if it's always the best option, especially for those with a certain type of lung cancer marker. So, they're calling for more studies to figure out the best treatment plan for older adults with different levels of this marker. It's like a puzzle they're trying to solve to make sure Grandma and Grandpa get the best care possible.
This study aims to establish the best clinical practice for the management of acute ischemic stroke related to narrowing or blockage of the neck vessels. Currently, the treating physicians use one of two surgical approaches based on their preference. However, we do not know which technique is the best. In this study, you will undergo mechanical thrombectomy using one of the techniques (stenting vs. non-stenting approaches) to determine which technique is better compared to the other.
The goal of this study is to get the highest possible quality of life restuls for individuals suffering lower-limb impairment after suffering a stroke. This will be done by examining three different modern carbon fiber ankle-foot orthosis (AFO) options targeting the rehabilitation of individuals post-stroke. The study seeks to achieve the best AFO prescription that maximizes the mobility and satisfaction of the particpant.
The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.
This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
The purpose of this study is to determine the best strategy to help individuals improve blood pressure control after a stroke. The study will test two different interventions (an intervention is an action taken to prevent or treat disease and/or improve health).
1) Intensive Clinic Management (ICM), which consists of clinic visits, home blood pressure monitoring, text message health reminder from Carium®, a care management application, and health education.
2) Intensive Tailored Telehealth Management (ITTM), which consists of telehealth (video) visits, health coaching with lifestyle coaching company INTERVENT International, LLC, and remote blood pressure monitoring captured in Carium®.