All Clinical Trials

This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida. Read Less

This study will recruit 260 female recipients (and up to a maximum of 130 donors). This study is a sequel to the protocol CP-DV-000-GEN-003, entitled, "NON-INFERIORITY STUDY COMPARING OVERTURE SEMI-AUTOMATED VITRIFICATION SYSTEM ("DaVitri") TO STANDARD MANUAL PROCESS USING BLASTOCYST RATE AS THE PRIMARY END POINT". Donors will provide informed consent and will be enrolled before egg retrieval. Once the oocytes are retrieved, they will undergo thorough denudation to remove corona cells and will be assessed for maturity. Subsequently, mature MII oocytes exhibiting good morphology, as per the Vienna Consensus, ranging between 12 and 30 in number, will be processed. These oocytes will then be randomly divided into groups comprising 6 to 8 oocytes each. Therefore, from a single donor, 2 to 4 groups can be generated. An identifier will be assigned for each group. One of the groups will be randomly selected. This group will be randomly assigned to DaVitri or Control. The remaining groups will be randomly selected and assigned alternatively to Control and DaVitri groups: Control oocytes will be manually vitrified and placed into cryogenic storage. Test oocytes will be prepared for vitrification using the DaVitri system. Following preparation with DaVitri, test oocytes will be loaded onto a cryogenic device that is placed into cryogenic storage. The same preservation media (Kitazato) will be used to prepare all oocytes. All oocytes will be warmed manually. Survival rate will be recorded following warming. After warming, the oocytes will be fertilized via Intracytoplasmic Sperm Injection (ICSI) with either donor or patient's partner sperm and resulting embryos cultured to blastocyst stage, keeping score of which embryos come from the Test or Control group. Fertilization rate will be recorded. Embryos will be morphologically assessed (according to Gardner grading system) on day 5-6 to determine blastulation rates and embryo quality in both groups. All the embryos will be vitrified according to the clinic\'s routine process and stored for further recipients. Recipients will provide informed consent and will be enrolled before the retrieval of donor eggs. Once the donor has been matched with the recipient according to the phenotypic, demographic characteristics (following the regular clinical process established in the clinic donation program), the group of oocytes assigned will be randomly selected from either the DaVitri processed group or the manually processed group. Recipients of donated eggs will receive a single embryo transfer (SET). The primary endpoint is Clinical Pregnancy Rate. Clinical Pregnancy will be confirmed by the presence of sac in uterus and chemical confirmation at 6-7 weeks after embryo transference, via ultrasound. Only the first embryo transfers will be used to calculate the primary endpoint. Successive transfers of any embryo group will not be considered inside the study. Read Less

This is a randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts. Part 1 will consist of single ascending dose (SAD) and Food effect (FE) cohorts, and Part 2 will consist of multiple ascending dose (MAD) cohorts. Read Less

The researchers are doing this study to find out whether tarlatamab is an effective treatment for DLL3-positive prostate cancer that has spread to other parts of your body (metastasized) and has either come back after treatment (relapsed) or not responded to treatment (refractory). Read Less

This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088). Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. This includes lung cancer, tumors that have spread to other parts of the body (metastatic), and tumors that cannot be removed with surgery (unresectable). Before this medicine can be given to cancer patients with liver problems, researchers need to understand how liver disease might change the way the body handles the drug. The study will include about 20 people divided into two groups: 10 people with moderate liver problems (called Child-Pugh B liver impairment) and 10 healthy people with normal liver function. The healthy volunteers will be matched to the liver patients by age, sex, and weight to make fair comparisons. All participants will take a single 20 mg dose of sevabertinib by mouth and stay in the research clinic for 5 days. During this time, researchers will take blood samples at specific times to measure how much drug is in the blood and how long it stays in the body. They will also monitor participants closely for any side effects. The main goal is to see if people with liver problems have different drug levels in their blood compared to healthy people. This information will help doctors determine if cancer patients with liver disease need different doses of sevabertinib to be safe and effective. The study will also look at the safety and tolerability of sevabertinib in both groups. Participants will have follow-up visits to ensure their continued health and safety. This research is important because many cancer patients also have liver problems, and understanding how liver disease affects this new cancer treatment will help ensure it can be used safely and effectively in all patients who might benefit from it. Read Less

Our proposed study, "NEUROBALANCE Stroke,"; aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance function and postural control in individuals with chronic stroke. The study will recruit 45 participants who have had a stroke at least 6 months before enrolment and experience persistent balance and gait deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation. The study will involve 15 training sessions over 5 weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies. Read Less

The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening. Read Less

The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-,2-,3-,4-, 8- and 12-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health. Read Less

The goal of this observational study is to better understand real-world use of vimseltinib, treatment patterns, and health-related quality of life in participants treated with vimseltinib for TGCT. This study will collect data in an observational disease registry involving no intervention to the participants and will not influence standard medical care or impact treatment decisions for participants. Read Less

This is a preliminary, prospective, cohort study to investigate the feasibility of using the COGED and Restless Bandit tasks after a mild to moderate traumatic brain injury as well as in healthy controls. Read Less

The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG. Read Less

This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to collect detailed information to help your physician and other researchers understand how dystonia impacts your and other patients' lives and how the disease changes over time. The study may also help researchers better understand the clinical scales that are commonly used to evaluate dystonia symptoms and how they affect various areas of life such as well-being, pain, relationships and social interactions, and progress over time. Because this is an observational study, you will not receive any interventional treatment in the study. Read Less