16 Clinical Trials for Various Conditions
The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens are presented to T cells. Various DC subsets with unique cell lineages, surface protein markers, and tissue localization determinants have been identified. For example, Langerhans cells (LCs) and interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the skin. Though both are expressed in the skin, they differ with respect to their origin and surface protein content and can activate distinct types of immune responses. They may also have different specificities for the capture of antigens and presentation to circulating T cells. To date, it is unknown what role, if any, the different DC populations that reside or repopulate in the skin play in the development and progression of skin graft-versus-host disease (GVHD) following bone marrow transplant.
The current surgical procedure for breast diseases places an emphasis on the conservation of breast skin in order to provide more optimal reconstruction. The purpose of this study is to use portable, non-contact optical imaging device developed at the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in a skin during reconstructive surgery procedure and healing process.
This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat and prevent recurrence of AKs. The target population comprises patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for possible influences of immunosuppression.
Background: Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant, resulting from the donor's immune cells attacking the cells of the body of the recipient. One effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function, decreased quality of life and increased risk of death. This is known as sclerotic skin changes of GVHD, or sclerodermatous graft versus host disease (ScGVHD). Imatinib mesylate (Gleevec) is a drug that has been approved by the Food and Drug Administration to treat cancer in humans and fibrosing conditions in animals. Objectives: To see if imatinib mesylate can improve ScGVHD and evaluate its effect on other GVHD symptoms To assess the side effects of imatinib mesylate in patients with GVHD To evaluate blood, body fluids and tissue samples in patients to try to better understand the biology of ScGVHD Eligibility: Patients 4 years of age and older with ScGVHD Design: Initial treatment: Participants take imatinib mesylate tablets once a day for up to 6 months, as long as their GVHD does not get worse and they do not develop unacceptable side effects of the drug. Evaluations: Participants are evaluated at 1, 3 and 6 months at the National Institutes of Health (NIH) Clinical Center with procedures that may include the following: Medical history and physical examination Blood and urine tests Lung function test Skin biopsy Magnetic resonance imaging (MRI) scan Specialty consultations (e.g., physical or rehabilitative therapy, dentist, eye doctor, dermatologist) Electrocardiogram (EKG) Echocardiogram (ultrasound test of the heart) Muga scan (nuclear medicine test of the heart) Quality-of-life questionnaires Apheresis (procedure for collecting quantities of white blood cells) Office visits with local physician once a week for 1 month, then once every 2 weeks for 5 months Followup visits at National Institutes of Health (NIH) every 6 months for 1 year Continuing treatment: Patients who improve continue to receive imatinib mesylate for up to 6 months after their best response and are followed for up to 2 years. Patients who continue to respond or who become worse after stopping treatment may receive additional treatment for up to 2 years.
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Calcipotriene will be used as the exclusive topical therapy in addition to standard of care GVHD treatment prescribed for the study subject by the primary physician.
RATIONALE: Efalizumab may be an effective treatment for graft-versus-host disease of the skin caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying the side effects and how well efalizumab works in treating patients with graft-versus-host disease of the skin that did not respond to previous steroids.
The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.
The purpose of this study is to assess the degree of improvement seen patient reported outcomes after 30 sessions of UVA-1 therapy in treating systemic scleroderma, morphea, and sclerodermatous Graft-Versus-Host Disease. While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, patient reported outcomes have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, patient reported outcomes may offer a better way to study the impact of treatments like UVA-1. This will be a non-blinded, non-randomized prospective trial using UVA-1 phototherapy in patients with established sclerosing skin disease. Patients will report the severity of their condition using multiple patient reported outcomes and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions.
Background: About half the people who have a hematopoietic stem cell transplant using donor cells get Chronic Graft Versus Host Disease (cGVHD). This is chronic graft versus host disease. Immune cells from the donor may see the body tissues in the person as foreign and attack, causing damage. The skin is the most commonly affected organ. Most cGVHD therapies have serious side effects. The cream ruxolitinib inhibits proteins that may play a role in cGVHD. Objective: To test the safety and effectiveness of topical ruxolitinib 1.5 percent cream in people with cGVHD of the skin. Eligibility: People ages 12 and older with epidermal skin cGVHD Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Skin sample taken (biopsy) to confirm the diagnosis. At the baseline visit, participants will have: Skin disease measured with rulers, photographs, and tracing the outline of skin lesions To complete questionnaires about their symptoms Blood and urine tests Some participants will also have a skin biopsy, or total body photographs while they wear only underwear. Participants will get the ruxolitinib cream and a placebo cream to apply to 2 separate areas of disease. They will do this twice a day for 6 weeks, if they do not have serious side effects. Neither the study team nor the participant will know which area will get ruxolitinib cream and the placebo cream. Participants will write down: * When they apply the creams * Any side effects * Any medications they take Most participants will have 4 visits during the 6 weeks they use the creams. Some will have 3 visits and a phone call to see how they are doing. All participants will get a call 4-6 weeks after they stop. Visits include physical exams, blood tests, skin disease measurements, questionnaires, and photos.
This study is being done to evaluate the effectiveness of a Sun Protection Strategies workbook for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at an increased risk of developing skin cancer. The program will help people learn about how to practice effective sun protection after the transplant.
This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.
Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Management of tuberculosis in this setting is challenging due to the complexity of diagnosis and the potential toxicity of anti-TB therapy, especially in liver transplant candidates and recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity (false-positive results due to interaction with BCG vaccine and other mycobacterial infections), and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G detects the release of interferon-gamma (IFN-γ) by sensitized white cells after incubation of whole blood with TB antigens. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI. This study advances research on the prevention of a serious bacterial infection that can have devastating consequences in the post-transplant setting. The new diagnostic strategy may more accurately determine the presence of LTBI, thereby allowing appropriate therapy.
The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face.
We hope to determine the importance of different genes (including B receptors) in anthracycline-induced cardiomyopathy. This has important benefits to patients exposed to anthracyclines, as this could help determine whether certain individuals have increased susceptibility to cardiac injury.