This study will examine genetic factors that contribute to the different ways people feel after consuming cannabis. People that use cannabis at least 4 days per week will participate in a study involving 1 in-person visit followed by a 5-day remote assessment period. The in-person visit will determine if an individual is eligible for study participation and their blood will be drawn to assess genetics. During the remote assessment period, participants will complete multiple short surveys per day describing their feelings and their recent cannabis use.
This is an international, multicenter, study that will not prescribe elafibranor. It is designed primarily to collect data and assess real-world effectiveness of treatment with elafibranor 80mg/day on adult patients with PBC, and to describe the safety of this treatment and its impact on their quality of life, over a period of 24 months.
This is a phase 2 study for patients that have been diagnosed with recurrent glioblastoma, a type of brain cancer. This study is testing an investigational combination of two drugs, reltalimab and nivolumab."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to see if there is a difference in overall survival rate in patients who receive a combination of retatlimab and nivolumab versus those who receive the standard of care treatment, lomustine, in patients with recurrent brain cancer. Participants in this study can expect to be in this study for up to five years from the day study participation starts. Subjects with investigational project being given on day 1 of each cycle, a cycle being 28 days. Cycles will continue until disease gets worse or study doctor decides it is in the subject's best interest to stop. Study will be divided into group 1 and 2. Group 1 will receive investigational drugs and group 2 will receive the standard of care. A computer will be used to assign groups in a process called randomization. Much like a toss of a coin, subjects will have equal opportunity to randomized to either group 1 or 2.
This study will evaluate whether a 5-day, 6-hours-per-day therapy camp called Camp Hand to Hands can help children with hemiplegic cerebral palsy improve their walking ability, stair climbing, and involvement in daily life. During the camp, children will wear a resting hand splint covered by a soft puppet glove on their stronger arm to encourage use of the more affected arm while participating in fun, play-based activities such as obstacle courses and crafts. The study team will conduct daily assessments of each child's walking endurance and stair navigation using the 6-Minute Walk Test (6MWT) and the Timed Up and Down Stairs (TuDS) test during the 5-day camp. Parents will also complete a brief questionnaire about their child's participation at home and in the community before and after the camp. The study seeks to determine whether this short CIMT program leads to improvements in mobility and daily function.
As growing research suggests noninvasive brain stimulation techniques have the potential to adjunct current treatments or treat Seizure-Type Functional Neurologic Disorder (FND-seiz), also known as Psychogenic Non-Epileptic Seizures (PNES), we aim to evaluate whether a form of accelerated intermittent theta burst transcranial magnetic stimulation (a-iTBS-rTMS), is a practical and well-tolerated treatment for people with this disorder. Transcranial Magnetic Stimulation or TMS uses magnetic pulses to stimulate a part of the brain involved in mood and thinking, the left dorsolateral prefrontal cortex, which has established benefits in disorders known to coincide in patients with FND-seiz, such as depression.
As an open-label, early feasibility study, enrolled participants will receive 6 to 10 treatment sessions each day over 3 to 5 days, with the goal of completing 30 total sessions. This approach was selected because similar protocols have already been shown to be safe and effective in other conditions, and the shortened treatment schedule in comparison to other protocols may make participation easier for people living with FND-seiz. The main goal of the study is to see how many participants can safely and comfortably complete at least 20 of the 30 TMS sessions.
The researchers will also evaluate changes in seizure frequency, quality of life, mood, post-traumatic stress symptoms, physical health, social functioning, and overall satisfaction with treatment. These outcomes will be measured before treatment and again four weeks afterward. The researchers also aim to explore whether people with overlapping conditions, such as depression or PTSD, respond differently to the treatment. Finally, given the overlap between epilepsy and FND-seiz, not all TMS providers are comfortable treating patients with FND-seiz when TMS is indicated for other conditions, thus the researchers aim to outline a protocol to ensure safety and increase TMS access for FND-seiz patients.
Solrikitug is an investigational drug, a drug that is still in development and testing, that can potentially benefit individuals with chronic obstructive pulmonary disease (COPD) by the pathway that causes type 2 inflammation. Solrikitug is given as an injection in the arm. Eligible participants will be randomized to receive a single dose of study medication (Solrikitug 375mg), three doses (day 1, week 4 and week 8) or placebo (inactive drug). The study is double blinded so neither the treatment team nor the participant will know what drug treatment they received. Enrollment in the study is up to 32 weeks, 4 weeks for screening and 28 weeks for treatment and follow up. Assessments conducted at the study visits include, but are not limited to, medical history and medication review, physical exams, blood tests, EKGs to look at the heart, breathing tests and questionnaires.
The purpose of this phase III study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis, which is not currently approved by the FDA. This study will last approximately 26 weeks, which includes a screening period that includes 1 or 2 visits. Eligible subjects will undergo a 1:1 randomization with the SL 1002 formula or normal saline used as a placebo. After the screening visits and the study drug treatment visit (Day 1), the subject will be required to return to the study site for 5 additional study visits at approximately 1,2,3,4, and 6 months after the study drug treatment (Day 1). These visits will include physical examinations, knee assessments, patient questionnaires, and the collection of vital signs, and blood and urine samples. This study also requires daily electronic data entries from Day 1 to the end of the study.
This is a Phase II clinical trial testing a drug called Telisotuzumab Vedotin in people who have already been treated for a specific type of lung cancer that has spread or is hard to remove with surgery. The cancer must show high levels of a protein called c-Met and have a normal version of another protein called eGFR. The main goal is to see how well the drug works and how safe it is when given in three different ways. Telisotuzumab Vedotin is a special kind of medicine that combines an antibody (which targets cancer cells) with chemotherapy. It's given through an IV (a tube in your vein), and each treatment takes about 30 minutes. Patients will get this treatment every two weeks on day one of the cycle. There will be four cycles in the study. There is also a 28 day screening window, a 30 day follow up period, post treatment follow up, and then survival follow up. The study itself will only last a few months, but the follow up will last for years. The follow up period will have limited contact compared to the main study. There will be around about 10 total study visits.
Genicular Artery Embolization (GAE) is a newer treatment aimed at reducing knee pain caused by osteoarthritis by targeting and reducing inflammation. In people with knee osteoarthritis, inflammation in the joint leads to the growth of tiny new blood vessels, called neovessels. These vessels are not normally present in a healthy joint and contribute to ongoing inflammation and pain.
GAE works by selectively injecting tiny particles into specific arteries that supply blood to these abnormal vessels. This process is called embolization, and it temporarily blocks the flow of blood through the neovessels.
Doctors use a special imaging technique called angiography to guide the procedure. This allows them to see the inflamed area and locate the neovessels, which are larger than normal due to the ongoing inflammation—usually about 1–2 millimeters in diameter.
By blocking these abnormal vessels, GAE helps to reduce the number of inflammatory cells and signaling chemicals (called cytokines) that enter the joint through the bloodstream. This decreases the overall inflammation in the area.
Additionally, the growth of pain-sensing nerves, which often occurs alongside these new vessels, may also be reduced. These nerves—called unmyelinated sensory nerves—can worsen pain when they are activated by inflammation. By decreasing both inflammation and nerve growth, GAE may significantly reduce knee pain in people with osteoarthris
The FDA has not currently approved the study device. Patients will undergo 8 visits over a 12 month period. screening, screening 2,treatment, 30 day follow up,90 days,180,270,365 follow up.
The purpose of the study is to learn more about an experimental drug called ORC-13661 that may be helpful in treating hearing loss due to antibiotic use. The study is researching whether the drug is safe and tolerable, and trying to find out whether the drug may be able to mitigate or prevent hearing loss in patients being treated with intravenous (IV) amikacin. Participation in the study will consist of up to 10 visits over up to 129 days. The Day 1 visit (following the screening visit) will last up to 8 hours, while other visits will last up to 5 hours Participants will be randomly assigned to receive either ORC-13661at a higher dose or a lower dose or a placebo (a pill that looks the same as the study drug but has no real medicine in it), for up to 90 days to be taken along with IV amikacin. Participants will be asked to have a number of tests and procedures, which include questionnaires about family, medical, and hearing history, physical and hearing examination, and assessments of hearing.