This study will evaluate whether using cold therapy before Anterior Cruciate Ligament (ACL) reconstruction surgery improves recovery during the first six weeks after surgery. Patients undergoing ACL reconstruction will either receive standard preoperative care or standard care plus a period of cold therapy prior to surgery. Pain levels, swelling, medication use, and functional recovery will be tracked using surveys and routine clinical follow-up information. participation will not change the surgical procedure or postoperative rehabilitation plan.
This study is for adult patients with Oral Squamous Cell Carcinoma (OSCC). The purpose of this study is to use results from a CLIA regulated blood test (NavDx) to measure tumor DNA to omit postoperative radiotherapy following surgery. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 2 years with a 3 year follow up period.
After years of research into bronchiectasis, the AIRTIVITY® Study is looking to see if an investigational medicine – designed to target the harmful inflammation that contributes to bronchiectasis – can help improve the lives of people living with the condition. The AIRTIVITY® Study was designed with input from bronchiectasis patient community representatives. Participants take part in this study for up to 1 year and 8 months. During this time, participants will be randomly assigned to receive either the investigational medicine (67% chance) or a placebo (33% chance). The study medicine will be provided as tablets to be taken once daily at home.
This study is for patients that have been diagnosed with locally advanced or metastatic solid tumor, including non-small cell lung cancer (NSCLC), triple-negative breast cancer, gastric cancer, esophageal cancer (or gastroesophageal cancer), head and neck squamous cell cancer, ovarian cancer, endometrial cancer, or cervical cancer. The study is testing and investigational drug called NRM-823. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety and tolerability of NRM-823 as monotherapy and in combination with pembrolizumab. The study drug is given as an injection into the stomach (or another place, like the thigh). An injection is like a shot between the skin and muscle so that the drug can enter your body. Participants can expect to be on this study until the first radiographic disease progression.
This study is for patients that have been diagnosed with diagnosed with primary advanced or recurrent endometrial cancers that express high levels of the human epidermal growth factor receptor 2 (HER2) protein and that have a genetic characteristic known as mismatch repair proficiency (pMMR). The study is testing investigational drugs called Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The purposed of this study is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy. The study drugs are given by infusion. Participants in this study can expect to be in this study for as long as you are receiving benefit from the treatment.
This study is for patients that have been newly diagnosed with GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL). This study is testing an investigational drug called zilovertamab vedotin. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In the study, participants will be randomized to two different groups (like flipping a coin). The first group will receive zilovertamab vedotin plus R-CHP [rituximab, cyclophosphamide, doxorubicin, and prednisone]. The second group will receive the standard care regimen: polatuzumab vedotin plus R-CHP. The drugs will be given through an IV, and prednisone may be given to participants by mouth. The primary purpose of the study is to learn if zilovertamab vedotin plus R-CHP is safe and effective for treating DLBCL. Participants in this study can expect to be in this study for up to 5.5 years. The first six months will be participation in treatment, and the following five years will be follow-up.
This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel group, efficacy, and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with a DSM-IV-TR diagnosis of ADHD. Approximately 286 subjects will be randomized to either SPN-812 or matching placebo in a 1:1 ratio (143 subjects per arm). Following up to 4 weeks of screening, subjects will be treated with study medication (SM) for 6 weeks, then will either be enrolled in a separate OLE study or followed for an additional 1 week for safety. The total duration of the study is up to 10 weeks.
This phase III trial compares the effectiveness of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Participants will be separated into two groups, or randomized (like flipping a coin). The first group of participants will receive high dose chemotherapy followed by an autologous stem cell transplant. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. The second group will be observed by the study doctor and study team with check-ins every six months for 12 years after joining the trial. The group of participants who receive a stem cell transplant will also be checked by their doctor and study team for every 6 months for 12 years after joining the study. The main risks of the study treatment include reduced blood cell counts, nausea and vomiting, and damage to other organs (due to high dose chemotherapy).
The study aims to evaluate if an experimental drug called SAR441566 can improve signs and symptoms of moderate to severe ulcerative colitis (UC). SAR441566 is a new drug that inhibits Tumor necrosis factor receptor 1 (TNFR1) signaling. This study will also help the Sponsor to understand which dose of SAR441566 is most effective and safe in participants with moderate to severe UC. To do this, 3 different doses of SAR441566 will be tested along with a placebo. The study will last about 1 year, will include about 260 adult participants across over 26 countries.
The purpose of this research study is to confirm the safety of the study drug (Prismocitrate 18) and the study device for patients with acute kidney injury receiving a type of dialysis treatment known as Continuous Renal replacement Therapy (CRRT). When a patient receives CRRT, a blood thinner (also known as an "anticoagulant") is frequently given. In the United States (U.S.), an anticoagulant called, Heparin, is commonly used for CRRT. Some patients have a high risk of bleeding and cannot be given heparin, because it can cause harm to them. For these patients, an anticoagulant, called citrate, can be used. The study drug being tested contains citrate. The study drug works as an anticoagulant and may also help cleanse your blood during the CRRT treatment.