24 Clinical Trials for Various Conditions
Background: * Blister fluid contains many of the same biomarkers (substances that can be used to determine the effects of certain kinds of treatments) as blood and urine samples, particularly regarding changes in the skin. * The Radiation Oncology Branch and others are conducting research studies that require blood and urine samples from healthy volunteers and from patients with cancer. In addition to these samples, researchers would like to collect the fluid from blisters to examine markers of inflammation in the skin. Objectives: * To compare blood, urine, and blister fluid samples of patients with cancer who are undergoing radiation therapy to that of volunteers without cancer who will not be receiving radiation therapy. * To gather more information about the effects of radiation therapy on the skin and body fluids of individuals. Eligibility: * Patients 18 years of age and older who will be receiving radiation therapy for either breast or prostate cancer. * A separate group of healthy volunteers will also participate in this study. Design: * Physical examination and blood samples to determine eligibility for the study. * Blister induction, conducted before the start of radiation treatment, at completion of radiotherapy (last day of treatment), and at a visit 12 months after the end of radiation treatment. * Blisters will be created through the use of a suction blister device on the hip (for patients with prostate cancer) or on the treated breast or location of removed breast (for patients with breast cancer). * Blisters will take approximately 30 minutes to form, and fluid will be removed with a needle and syringe. * Blood and urine samples will also be collected at this time. * Radiation treatment for breast or prostate cancer will be conducted according to standard procedures, or as directed by a separate research protocol. * Evaluations during the treatment period: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Blood and urine tests. * Disease evaluation. * Post-treatment evaluations: * Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for physical examination and disease assessment. * Study will end 1 year after the final radiation treatment, upon the collection of the final (third) blister fluid sample.
Background: The way the body heals and protects itself from getting sick is called the immune response. Some people with weak immune systems get sick often or get rashes and skin infections. Researchers want to find out how the immune system and skin problems are related so they can help these people. Objective: To learn about how immune response and skin healing are related to each other. Eligibility: People ages 18-65 with hyper IgE syndrome or Job syndrome or people ages 7-65 with chronic granulomatous disease. Healthy volunteers ages 18 65 are also needed. Design: Participants will be screened with: Medical history Physical exam Possible urine tests Participants will have 1 to 3 visits within about a week. Visits will include the following: Participants will have a wells device strapped to the inside of the forearm. It will suction the skin and pull the top layer away to form 8 blisters. The skin over the blisters and the liquid inside will be collected. Participants will have up to 4 skin biopsies. A sharp tool will remove a small plug of skin from the forearm. Participants may have blood and urine tests. The skin on participants skin will be rubbed with a cotton swab. Some participants will have an overnight visit. They will have the blister device placed back on the arm. The wells will be lined up over the blister wounds. The wells will be filled with either saline or the participant s blood serum. The device will be covered and left on the arm for up to 24 hours. Doctors will periodically remove some liquid from the wells.
The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings). Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.
Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will require the availability of validated disease severity measures that can be used to define primary outcomes.
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer compression over that of multi-layer compression alone, in the treatment of venous leg ulcers. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain. Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Epidermal grafting has been a reconstructive option for decades; however, to date there has not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting System permits the harvesting of epidermal blister grafts at the patient's bedside without the need for anesthesia. The grafts can be easily transferred to the wound bed. In case studies, epidermal grafting appeared to be effective in reducing wound size and accelerating closure of venous leg ulcers.
The purpose of this research is to study alternative treatments for the skin disease pemphigus (a rare autoimmune blistering disorder of the skin) by using sirolimus, an immunosuppressive drug. Immunosuppressive drugs inhibit or prevent the activity of the immune system and are commonly used to treat autoimmune diseases, inflammatory diseases, and organ transplantation rejection.
This quantitative, interview-based study will determine if increased prescription medication adherence via blister pack administration will reduce suicide related behavior among the high risk population of patients discharged from a psychiatric inpatient unit. The aims of the project are to determine whether blister packaging medication significantly increases treatment adherence and if blister packaging significantly decreases intentional self-poisoning behavior (i.e., suicide attempts and completions). By tracking former psychiatric inpatients for 12 months post-discharge and obtaining monthly medication adherence ratings, we will determine if blister packaging (BP) medications leads to better adherence than dispensing as usual (DUA). The psychiatric patients we will be recruiting have been diagnosed with, major affective disorder, bipolar affective disorder, post-traumatic stress disorder, or schizophrenia (or any combination of these diagnoses). By tracking former psychiatric patients for 12 months post-discharge and obtaining monthly reports (self-report and medical record review) of suicide-related behaviors, we will determine if patients in the BP condition have less intentional self-poisoning behavior than those in the DAU condition.
The use of a suction blister apparatus has facilitated study of the immunologic capacity of human epidermal cells. We have been able to prepare purified populations of these cells after blister formation. Specifically, using the blister tops, we are able to enrich for epidermal Langerhans cells which are very potent stimulators in antigen presenting assays. Thus, this normal volunteer study provides an important source of fresh epidermal tissue from which we can study normal epidermal Langerhans cell function. In addition, we have recently used blister roofs in important experimental models of HIV-1 transmission. There is no other method available for assessing the biologic function of freshly isolated Langerhans cells without altering their milieu. It is a very safe and effective way to obtain human epidermal samples.
Blisters are a very common complaint in both the general population and also the athlete. This study's aim is to determine whether applying paper tape (an inexpensive and common component of most foot care kits) to the foot of endurance runners prevents the frequency and severity of friction blisters.
Friction foot blisters are one of the most common and often debilitating complaints of all athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether applying paper tape to the areas of the foot where blisters historically occur in endurance runners can prevent the incidence of friction blisters.
Unintentional poisonings of children continues to be a major issue in the US. According to a study conducted by Cincinnati Children's Hospital Medical Centers, during the period from 2001-2008, emergency room visits for children less than 5 rose 28% as the result of pharmaceutical products. The authors note, "the problem of pediatric medication poisoning is getting worse, not better." Child resistant closures have been required on most medications sold in the US since the early 1970s. However, most designs attempt to thwart children through purely physical means (e.g. simultaneous dissimilar motion or opening using sequential tasks). Few, if any designs, have utilized perception and cognition as a way to enhance child resistance. The investigators propose utilizing visual illusions in spaces distinct from the opening mechanism of prescription packages as a means of enhancing child resistance. In this project, visual illusion images are applied to both vials and wallet blisters in order to attract children's interest and prolong the time before opening. During Stage I, the investigators will determine if the visual distractor attracts attention when samples are displayed in a storage rack. During Stage II, the investigators will test the effect of visual distractors on child resistance as measured by successful openings and time to open.
The investigators are undertaking a clinical blister model with or without dietary supplementation with omega-3 fatty acids (i.e., Lovaza) to determine the role of specialized pro-resolving mediators - endogenous lipids converted from omega-3 fatty acid precursors including those in Lovaza - on inflammation parameters and their resolution.
The purpose of this study is to understand the immune response to coronavirus disease-19 (COVID-19) vaccination in patients on B-cell depleting therapies (BCDT) over time, which in the future may help to inform clinical decision making in this patient population.
The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.
This is an open-label, proof-of-concept, single group study in adult patients with newly diagnosed, moderate to extensive BP. The study will consist of three periods: a screening period of up to 2 weeks, an open-label treatment period lasting 4 weeks consisting of IV infusion of bertilimumab on Days 0 and 14 and 28, and a safety and efficacy follow-up period of approximately 13 weeks. Patients will receive concomitant oral steroids during the treatment and follow-up period.
TolaSure is a topical gel for the promotion of accelerated wound healing. This Phase I study will assess the safety, tolerability, and clinical effects of TolaSure when applied to wounded skin areas of patients diagnosed with severe epidermolysis bullosa simplex (i.e., EBS-Dowling Meara). A total of 10, severe EBS patients, males and females ages 18 years and older, will be enrolled. Patients will apply TolaSure and Vehicle Gel once-daily for a maximum of 10 weeks.
A phase III two-part study of nomacopan, a bifunctional inhibitor of complement component C5 and leukotriene B4 (LTB4), for the treatment of moderate and severe bullous pemphigoid. There is evidence that both terminal complement activation (via C5) and the lipid mediator LTB4 may have a central role in driving the disease. In this study patients will be randomized to receive either nomacopan plus oral corticosteroids (OCS) or placebo plus OCS for a treatment period of 24 weeks. OCS will be tapered over the course of the treatment if the symptoms of disease improve.
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).
Background: - Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory system. Sometimes people who get sick with staph infection do not get better with standard treatment. These staph infections can be serious and even deadly. Researchers want to find out why some people are more likely to get the infection. Objectives: - To look at the immune response of the skin when it is exposed to bacteria. Eligibility: * People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph infections. * Healthy volunteers. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may have additional tests if needed. If they had a recent biopsy, researchers may ask for a sample from it. * Some participants will spend the night at the clinic. Their vital signs will be taken and they will have blood drawn. Some participants will take aspirin or ibuprofen starting 2 days before their stay. * Some participants will have blisters created on the inside of their forearm. Suction will pull a layer of skin from their arm. Skin will be removed. Different solutions will be applied to the blisters. Up to 3 biopsies may be taken. * Children will not have blood tests or biopsies. * Participants will be called every day for 10 days, then at 30 days after the procedure. * Participants will have a follow-up visit 10 days after the procedure. * Participants who did not get blisters or biopsies will not have any follow-up appointments.
The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of patients with pemphigus vulagaris (PV).
The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.
Cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous membranes, and, in a small subset of patients, the eye. Progressive ocular disease can lead to irreversible damage and blindness. Conventional treatments include systemic steroids, dapsone, and immunosuppressive agents. These treatments, however, are not successful with all patients. Rituximab has been very effective in the treatment of other autoimmune disorders, and has recently been shown to be effective for autoimmune blistering pemphigus. We propose that it will also be effective in the treatment of cicatricial pemphigoid.
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
Background: -This protocol is concerned with the acquisition of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin diseases to support the basic science and clinical research activities of the Dermatology Branch and other intramural Laboratories and Branches at the NIH Clinical Research Center. Objectives: (Primary) -To allow collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases as needed to support the research activities of our Branch and other Laboratories and Branches. Eligibility: * Healthy individuals (including employees and other patients) and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups. * Patient volunteers must be willing to undergo blood drawing and/or skin/mucosal biopsies. Design: -This is dependent upon the particular investigation for which these samples are needed.