This study is being done to evaluate the long term safety of ARQ-151 cream 0.15% and ARQ-151 cream 0.5% in subjects with mild to moderate eczema (atopic dermatitis). Eligible subjects will enroll in the long term safety study after they have successfully completed the preceding study. Study medication will be applied topically for 52 weeks at home. All affected areas, except on the scalp, will be treated. For the first 4 weeks of study, all subjects will apply study medication once a day in the areas identified and treated during the preceded study. Beginning at the Week 4 visit, any subject who achieves vIGA-AD of ‘0-clear' as confirmed by the Investigator at a scheduled or unscheduled clinic visit, will switch to twice weekly (BIW) maintenance treatment. For maintenance therapy, study medication will be applied on two nonconsecutive days per week.
This study is being done to evaluate the safety and efficacy of ARQ-151 cream in subjects with mild to moderate eczema (atopic dermatitis) after application once every day for a month. Results will be compared against a vehicle (placebo). The vehicle is a dummy drug made from the same base product used to make ARQ-151 cream, but it does not contain any active study drug. ARQ-151 is a cream that contains the active ingredient roflumilast. Roflumilast is marketed in Canada, the United States, and other countries as a tablet (pill taken by mouth) for flares of a specific chronic lung disease. You will apply the study drug on your eczema lesions once a day for 28 days. The study doctor will tell you which lesions to treat. Any newly appearing eczema lesions that arise during the study must also be treated.
This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device.
Patients aged between 4-21 years are eligible to participate. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions. Safety profile and patient tolerability will be measured, as well as changes in size, pain and appearance. Photographs and clinical impression will be used to measure treatment response. Pain and tolerability will be assessed by a visual analogue scale and tolerability assessment scale.
Babies that are born extremely prematurely are at higher risk of developing a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants.The main purpose of this study is to see if IBP-9414 ( a probiotic) can prevent NEC and if it is safe and tolerable.
IBP-9414 (Lactobacillus reuteri) is a live bacterial therapy given to infant's through a feeding tube or it is given by mouth once daily starting at or before 48 hours of life. IBP-9414 will be given daily until the infant reaches 34 weeks + 6 days Post-Menstrual Age (PMA) (the the baby's gestational age at birth plus the postnatal days of life), or until treatment is permanently discontinued if earlier.
This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.
The largest published COVID-19 pediatric series to date included only 13 patients considered to be critically ill and only described the Chinese outbreak. There are essentially no data outside of this and nothing to begin to understand the prevalence of severe/critical pediatric COVID-19, the risk factors associated with this illness, outcomes from COVID-19, and factors (patient or treatment) that may be associated with an improved or worsened outcome. This study will identify all children admitted to an inpatient unit with a diagnosis of COVID-19. Clinical data will be collected through medical record review to describe in detail the demographics and clinical characteristics, including clinical course and treatment, of infected children who require hospitalization.
Pediatric traumatic injury (PTI) – defined as unintentional injury requiring hospitalization and, often, extended periods of physical and emotional recovery – is experienced by 300,000 children in the U.S. annually. Roughly 20-40% of children and caregivers develop posttraumatic stress disorder (PTSD) and/or depression following PTI, yet most U.S. trauma centers fail to provide even basic mental health screening post-injury. It is critical to advance our knowledge of available mental health services in trauma centers for this frequently overlooked population to accelerate their physical and emotional recovery. In this project, trauma center providers across the U.S. will complete a survey and a qualitative interview to assess their current protocols and resources available to screen and treat children and families' mental health in the aftermath of PTI, as well as their opinions regarding feasibility of implementing protocols to better address the emotional health recovery within this population.
The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.