The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) reduces opiate craving and pain in Veterans who are receiving treatment for opioid use disorder. The study will last approximately three months. There will be a screening visit to determine eligibility, followed by the treatment phase during which participants will receive six sessions of rTMS a day for three non-consecutive days. This period may take up to three weeks. There are follow up visits at one week, four weeks and three months after the treatment phase has ended.
During rTMS, focused magnetic waves are directed at a part of the brain that is important in pain, and craving, to increase its activity. If you participate, you will receive six sessions of either active rTMS, or placebo rTMS, each day for three days (18 total sessions). Each session lasts 15 minutes. People typically do not have side effects with rTMS, though they initially may find it mildly painful at the application site. About 1 out of every 20 people who get rTMS have mild headaches after sessions that are typically relieved with over-the-counter medicines. A few people who have had rTMS have had seizures, though the chance of this happening is very small.
This is an open-label, nonrandomized, dose escalation and dose expansion, safety, efficacy, PK and PD evaluation study of SAR439859 administered orally as monotherapy, then in combination with palbociclib. The study will last approximately 26 months, and participation in the study may last 4 to 8 weeks or longer. The length of participation in this study will depend on how well subjects tolerate the study drug and the condition of their disease.
The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).
The purpose of this study is to is to investigate the combination of CV301 (an experimental cancer vaccine) with anti-PD-1 Therapy (atezolizumab which was approved for the treatment of advanced Urothelial Bladder Cancer) for treatment of locally advanced or metastatic UC.
CV301 involves the use of a two-component dosing regimen; a prime vaccine, MVA-BN-CV301 (the first vaccine generating a response from your immune system) and a boost vaccine, FPV-CV301 (the second vaccine increasing and maintaining the response of your immune system). Treatment with anti-PD-1 therapy may help the immune system detect and attack cancer cells.
In this clinical trial the use of CV301 vaccine in combination with atezolizumab infusion is being investigated to determine whether the overall survival and immune response observed in subjects treated with atezolizumab can be enhanced when combined with CV301.
This clinical trial is being performed at up to 8 clinical trial sites, and 68 people in total will be selected to participate. The trial is scheduled to last up to 104 weeks from the time you are first seen at the trial site until you start the long-term follow-up contacts. Once deemed eligible for participation, visits are every 3 weeks for the first 16 weeks on study. Then, visits will be every 6 weeks until week 28 on study, at which time visits will be every 12 weeks until end of treatment.
Participation in this trial will not guarantee any direct or immediate benefit, but can help gain future knowledge about the treatment of UC that may be beneficial to others with this disease.
This study is for subjects with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The investigational drug in this study is BST-236, which is given via IV. The purpose of this research study is to measure the safety of BST-236 and how effective it is in treating subjects. Visits will be required for 6 consecutive days during each cycle of treatment. The number of courses you receive will depend on whether you are benefiting from the study drug. Participants can expect to be in this study for 2 years (including treatment and post study follow-up).
The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection.
If you are eligible and choose to be in the study, the dose of study drug you receive (125 units or 250 units) will depend on your clinical assessment, the severity of your disease, and whether you have had any toxin before.
The study may last up to 55 weeks, including 3 weeks of screening. You will come to the study center up to 15 times.
The study is being done at approximately 80 sites. Approximately 290 adults with moderate to severe isolated CD, who are 18-80 will take part study-wide and 4 will take part at this institution.
The purpose of this study is to evaluate the safety and effectiveness of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin, and leucovorin called mFOLFOX6), for the treatment of gastric and/or gastroesophageal cancer and other solid tumors. The entire study (Phase 1 and Phase 3) is expected to take about 66 months to complete. MUSC is participating in the phase 3 portion only.
The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.
The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection. Placebo means it doesn't contain botulinum toxin type A.
If you are eligible and choose to be in the study, the dose of study drug you receive will depend on the group that you will be put into after randomization at the time of your entry.
You will be assigned, by chance, to 1 of the 3 groups below:
? Group 1: High-dose (250 Units of daxibotulinumtoxinA for injection)
? Group 2: Low-dose (125 Units of daxibotulinumtoxinA for injection)
? Group 3: Placebo (a substance that looks like daxibotulinumtoxinA for injection but has no drug in it)
Study lasts aproximately 39 weeks, including 3 weeks of screening. You will come to the study center up to 12 times during the research study.
The study is being done at approximately 80 sites. Approximately 300 people will take part study-wide and 4 will take part at this institution.
This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL). The investigational drug in this study is loncastuximab tesirine (ADCT-402). The purpose of this Phase 2 study is to evaluate the effectiveness and safety of loncastuximab tesirine in subjects with DLBCL that has not responded to treatment or has come back after treatment.Treatment will occur every 3 weeks. The follow up treatment period will last up to approximately 3 years.