44 Clinical Trials for Various Conditions
This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. Subjects will be followed to age 18 months. A total of 44 subjects will be PediaBerry group and 22 subjects in the placebo control group.
The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.
We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. These birthmarks tend to disappear spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's health, which occurs in about 1 in 3 children with hemagiomas. Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma. The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas have received timolol maleate. The results so far show that timolol maleate may be helpful and safe in treating hemangiomas in infants. An important question being tested in this study is whether pulsed-dye laser or timolol maleate can prevent hemangioma from growing when used very early after birth.
The investigators hypothesize that there are differences between infantile hemangiomas (IH) during the proliferating and involuting phases and in response to medical treatment that can be detected by optical tomography of these hemangiomas.
Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all have the potential for significantly harmful side effects. The purpose of this study is to identify potential biomarkers that can be used to design clinical trials and accelerate the delivery of new treatment alternatives to children with hemangiomas.
The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.
The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.
This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.
1. PHACE syndrome(OMIM database number 606519) is the association of a vascular birthmark (hemangioma) on the face along with one or more of the following conditions: congenital heart defects, congenital anomalies of the cerebral arteries,brain, eyes, or sternum. 2. A research study is currently being conducted at the Medical College of Wisconsin (MCW) to investigate if there is an inherited cause of PHACE syndrome. 3. We are hoping that this study will lead to a better understanding of how and why children develop PHACE syndrome.
The purpose of this study is to evaluate the genotype of CTCF, a proven transcription factor, in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to determine whether or not the CTCF genotype might serve as an early and reliable predictor of tumor growth.
Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.
The goal of this study is to determine the safety and efficacy of Prednisolone and Vincristine for treatment of large, complicated infantile hemangiomas. The diagnostic, therapeutic and response criteria experimentally determined in this study will be used as a framework for future infantile hemangioma studies.
The purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as they relate to normal pregnancies and those pregnancies complicated by placenta abnormalities. Women of all gestational ages will be enrolled in the study. Maternal serum, placental, and cord blood samples will be obtained for each subject. A medical history will be obtained for each subject. Post-delivery a member of the study team will perform a cutaneous exam of the infant to establish what birthmarks are present at birth. Mother will receive four phone call follow ups to determine if the infant has had any skin changes. If yes, mother will be asked to bring the child in for evaluation. If a hemangioma is diagnosed, a blood draw will be performed.
The purpose of this study is to determine if there are genes that are common in children with infantile hemangioma. This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with infantile hemangioma. There are very few medications to treat infants with hemangiomas.
We are conducting a study on the possible presence of PHACES in children with large facial hemangiomas and lumbosacral hemangiomas of infancy (hemangioma in the lower back) . With this study we hope to better understand the risk of this syndrome and to develop guidelines for its evaluation and management.
This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.
This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH. The primary objective: To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks. The secondary objective: 1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS). 1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire.
The purpose of this study is to assess the baseline sleep pattern disruption for patients starting oral propranolol at the standard BID dosing regimen compared to the control (timolol) group and to determine if there is a significant improvement in the sleep patterns in infants taking oral propranolol on the TID dosing regimen versus the control (timolol) group
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.
This is a single patient investigative treatment study. The patient was diagnosed with a retinal tumor in one eye. In the last 2 years, the patient has been treated with all available and conventional therapies, including intraocular injections of Avastin and Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and caused an eventual decline in central vision. Aflibercept has been shown to be effective against the growth of new vessels, secondary to macular degeneration. This study proposes that it may also be more effective in treating this particular patient and case. The study treatment plan is for 6 months initially, with the intention to continue treatment.
The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma.
There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.
One of the most important and unique characteristics of infantile hemangiomas is their dramatic growth during early infancy. Most hemangiomas are either absent at birth or barely evident as a small scratch or bruise-like area. A recent study emphasized how early hemangioma growth occurs. In this study by 3 months of age, hemangiomas had reached 80% of their final size, and by 5 months of age, 80% had already stopped growing. Unfortunately the average age when most infants are seen by specialists is often at 5 months of age or later, a time when most growth is already completed. Researchers at the University of California, San Francisco, the Medical College of Wisconsin, and at the Mayo Clinic are interested in studying hemangioma growth at even earlier ages, before 3 months of age, which is before most patients are ever seen by dermatologists or other specialists. For this study are requesting that parents of children older than 3 months of age with hemangiomas send us a series of photographs of their child which demonstrates this early growth. Ideally the photographs would show your child (including the area of the hemangioma of course) at weekly or every other week intervals up until age least 3 to 6 months of age. This will probably not be difficult if the hemangioma is on the face but we would be interested in other body locations as well, if available. We are using these photographs to analyze early hemangioma growth patterns, to see if there is a period of especially rapid growth, and to help determine if there is a specific time before which specialty referral should occur. We are interested in all sizes of hemangiomas, from small to large. Of greatest importance is that the photos be at frequent intervals (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance of the hemangioma.
The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas.
Tumors of the spine can be described as primary, meaning that the tumor originated from cells normally found in the spine, or metastatic, cells from another area of the body that have spread to the spine. Metastatic tumors are more common than primary tumors. Tumors of the spine can press against the spinal cord and interfere with information traveling down from the brain to the nerves of the spinal cord. As a result, patients with spinal tumors can suffer from loss of movement and sensation within areas of the body below the tumor. In addition, tumors of the spine are typically painful conditions. Presently, the treatment of choice for spinal tumors is radiation therapy. However, many tumors of the spine become resistant to radiation therapy. In addition, because the spinal cord is often so close to the tumor it can be damaged by the radiation. Absolute (100%) ethanol is commonly known as "alcohol". It is the same kind of alcohol found in alcoholic beverages. When pure alcohol is injected directly into a tumor it can destroy cells and blood vessels. Because of this feature, researchers would like to test the effectiveness of alcohol in treating patients with spinal tumors. Researchers believe that intratumoral ethanol injection is a treatment worth studying more closely because it is minimally invasive, has been proven to be an effective treatment for other types of metastatic tumors, can be used repeatedly, and does not interfere with other treatments such as surgery. In addition to testing the effectiveness of intratumoral ethanol injection, this study will attempt to determine the causes of pain associated with spinal tumors.
Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused by an inherited gene mutation (alteration) in one of three CCM genes (CCM1, CCM2, or CCM3). There is a wide range of disease severity even among family members with this disease, though the natural history has not been clearly described for this particular population. This study will continue to enroll and follow participants with familial CCM to identify factors that influence CCM disease severity and progression, focusing on barriers to clinical trial preparedness. Our long-term goal is to identify measurable outcomes and robust biomarkers that will help select high-risk patients and help monitor drug response in future clinical trials. The specific goals of this study are to: * Identify factors that influence lesion progression to symptomatic hemorrhage and other outcomes, including quality of life; * Investigate the role of the gut microbiome and lesion burden in CCM disease, and * Identify blood biomarkers predictive of CCM disease severity and progression for clinical trials.
Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.
The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject. The investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. The investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas. In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of care, electrodessication.