The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for tobacco use disorder when delivered in conjunction with brief motivational enhancement therapy. Subjects will receive ketamine assisted motivational enhancement therapy weekly for three weeks. If you are eligible and you decide to enroll in the study, your overall participation will last approximately 8 weeks.
The study is for patients that have been diagnosed with platinum-sensitive high-grade serous ovarian cancer. The investigational drug used in this study is XMT-1536 (upifitamab rilsodotin). The main purpose of the study is to compare progression free survival (the length of time that participants live without their disease getting worse) for participants with ovarian cancer with high NaPi2b level on their tumor cells treated with XMT-1536 versus placebo, following standard chemotherapy. Participants can expect to be in this study for up to 24 months.
While there are medications for PTSD, they don't treat all the symptoms and only affect the severity of some symptoms instead of reducing symptoms overall. As a result, you may be considering other options for your PTSD.
One option to consider is this clinical research study of an oral investigational drug for adults diagnosed with PTSD. In this study, doctors want to evaluate the safety and effectiveness of the investigational drug and compare it to a placebo, which looks like the investigational drug but contains no active medicine. The investigational drug has been studied in clinical research studies before, but it is not approved to treat PTSD. People with PTSD can only receive the investigational drug in clinical research studies like this one.
The results of this study will provide more information about the
investigational drug and whether it could one day be prescribed to
If you are eligible for this study and agree to participate, you will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. You have an equal chance of receiving either study drug (investigational or placebo).
You, the study doctor and the study staff will not know which study drug you are receiving. However, in the event of an emergency, this information can be provided.
You will take your assigned study drug once a day for 8-weeks. You will attend up to 8 study center visits for tests, procedures, interviews, and questionnaires to evaluate your health and PTSD. You will also receive 4 phone or video calls from the study doctor/staff to talk about how you are feeling.
Your total study participation will last approximately 16 weeks, which includes screening for eligibility, study drug dosing, and follow-up.
This study is designed to evaluate the efficacy and safety of semaglutide s.c. 7.2 mg once-weekly versus placebo and semaglutide s.c. 2.4 mg once-weekly as an adjunct to reduced-calorie diet and increased physical activity in adults with obesity.
The maximum duration of the study intervention for each participant is 72 weeks and the duration of the study for each participant is 81 weeks.
In this Phase II trial the efficacy of treatment in patients with clinically significant portal hypertension (CSPH), in compensated alcohol-related cirrhosis, will be assessed. This will be the first trial in the clinical development of the drug BI 685509 where patients will be treated for 24 weeks, and where the portal pressure will be assessed quantitatively via HVPG measurements. The trial will evaluate both short-term and long-term efficacy. The long-term assessment will be used to rule out any adaptation to sGC activation on portal pressure on chronic treatment. The trial will also provide supportive evidence for the planned Phase III development.
This study is to look at how well the new medicine CagriSema works at assisting weight loss for people with excess body weight, compared to "dummy" medicine and 2 other medicines.
The 68-week main phase of the present study is designed to compare the efficacy and safety of once-weekly cagrilintide in combination with semaglutide versus once-weekly cagrilintide, semaglutide, and placebo, all as an adjunct to a reduced-calorie diet and increased physical activity, for weight management in participants with overweight or obesity.
The study will also include a 97-week off-treatment period for participants in the CagriSema and placebo treatment arms only (extension phase), to obtain a better understanding of the impact of withdrawing the study interventions on weight, cardiovascular risk factors and glucose metabolism in people living with
overweight or obesity.
This study will involve taking one or two medications already approved by the Food and Drug Administration (FDA) for treatment of type 2 diabetes to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease in individuals with type 2 diabetes who are at least 40 years old. Participation includes about 8 study visits over a period of 72 months, which can be performed over the phone remotely or during normal standard of care clinic visits. Participants will be compensated for their time and participation in this research study.
This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects > or = to 6 years of age with lamellar ichthyosis, and aims to assess the bodily absorption of the cream across application frequencies. Subjects with ARCI/RXLI will be randomized 2:1, to either receive the TMB-001 0.05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. Prior to the Phase III trial, subjects will have the option to participate in a 14 day treatment period with TMB-001 0.05% - twice daily - followed by continued treatment with TMB-001 0.05% twice daily for 10 weeks.
This study will enroll participants who are hospitalized with decompensated heart failure. Heart failure is a condition in which the heart is not able to pump blood efficiently and as a result fluid can build up. This study is testing an investigational, not yet approved for commercial use by the Food and Drug Administration (FDA) device called the Repreive DMS. The Repreive DMS is an instrument designed to automatically administer medications called diuretics to optimize fluid removal and improve your symptoms of heart failure. This study has a randomized arm in which participants will be randomly assigned to treatment with the Repreive DMS system or standard of care treatment referred to as Optimal Diuretic Therapy. You have a 50:50 chance of being assigned to either arm. There is also a registry arm for participants who do not wish to participate in the randomized part of the study. The registry involves collecting data from your standard treatment. The randomized study will last about 13 weeks and involved up to 9 visits. The Repreive DMS involves infusing medication through an IV (intravenous or in the vein) and collecting urine via a foley catheter, which is placed in your bladder. Some of the other procedures involved in this study include physical exams, blood work, urine studies, hearing test, and medication administration.
If you are an adult over 40 years of age with atherosclerosis cardiovascular disease (heart attack or ischemic stroke or narrowing of arteries in legs due to plaque) and a LDL cholesterol greater than 70 mg/dL, you may be eligible to take part in a clinical research study. The purpose of this study is to evaluate the benefit of inclisiran on major cardiovascular events while taking either atorvastatin or rosuvastatin cholesterol lowering medications. Study participants will be randomly assigned to take either inclisiran or placebo (inactive medication). Study visits during the treatment period will occur every three months twice and then every six months for up to six years. If eligible, study medication and study visits will be provided free of charge. Compensation is available.