DIVERT: Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial:...
Ruptured Aneurysm of Intracranial ArteryThe purpose of the DIVERT study is to provide a prudent, controlled clinical context for the use of flow diversion, a promising option of yet unproven benefit, in the care of patients with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple, multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical dilemma of whether the use of PED FD truly is a safe and effective alternative to best standard treatment, defined as conventional methods of treatment or in some cases, observation. Selection criteria are few, to facilitate the recruitment of most affected patients confronted with these difficult aneurysms that their physician judges suitable for PED FD. The trial does not obstruct clinical care, does not include extra tests or risks beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful, valuable and resistant to bias. Follow-up visits and tests are "routine', imposing no extra burden on clinical transactions. Data is collected in simple case-report forms filled by physicians.
Fish Oil-derived N-3 Polyunsaturated Fatty Acids and Extracellular Vesicles
Extracellular Vesicles; Generation and FunctionN-3 polyunsaturated fatty acids (n-3 PUFA), which are abundant in oily fish and fish oils, have been suggested to play a role in reducing the risk of cardiovascular diseases (CVDs) by modifying a wide range of risk factors, such as blood fats, blood clotting, blood vessel function and inflammation. Extracellular vesicles (EVs) are small particles released from various cells when they are activated or damaged. High numbers of EVs in the blood have been associated with a higher risk of CVDs, and it is thought that this is because they carry 'bioactive' components which can affect many processes involved in CVDs. However, very few clinical trials have investigated the relationships between the consumption of n-3 PUFA and circulating EVs. This study aims to investigate the effects of dietary n-3 PUFA on the generation and functional activities of EVs, which would provide new insight into the benefits of n-3 PUFA on cardiovascular health.
Impact on Patient COmpliance With Medication Using Pre-packaged Blisters for Long-term Medical therapY...
Medication AdherenceMedication ComplianceThe use of packaging interventions like pillboxes or blister packs has been shown to significantly improve medication adherence. The purpose of this study is to assess the effect of home-delivered pill packs on medication adherence in a low-income population. This is an open-lab randomized controlled trial taking four or more medication doses daily, randomized either to the intervention group or the control group. Patients in the intervention group received prescriptions pre-packaged in individual packets that were delivered by the pharmacy. Patients in the control group continued to receive medications from pharmacies as they did prior to enrollment. The primary outcome was the percentage of missed pills in the intervention group versus the control group after four months of enrollment.
Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
InflammationThe purpose of this study is to refine the cantharidin-induced blister assay in healthy volunteers as a model of inflammatory disease. The study is an experimental trial in healthy volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two anti-inflammatory treatments with different modes of action.
Pro-Resolving Mediators in Acute Inflammation in Humans
Inflammation; SkinResolution1 moreThe 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.
Visual Distraction as a Means of Enhancing Child Resistance
Unintentional Ingestion of Drugs Contained Within Prescription Vials and 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.
Cantharidin-induced Skin Blister for Testing Anti-inflammatory Effects of Macrolides
InflammationThe purpose of this study is to investigate the utility of the cantharidin-induced skin blister assay for evaluation of the anti-inflammatory effects of macrolides in healthy male volunteers.
Effect of Darapladib on Cantharidin-Induced Inflammatory Blisters in Subjects With Type 2 Diabetes...
AtherosclerosisThis will be an exploratory, open-label, single sequence, two part study (Part A and an optional Part B). The aim of this study will be to assess whether systemic inhibition of Lipoprotein associated phospholipase A2 (Lp-PLA2) in humans, effected by 11 days of once daily dosing to steady state with 160 milligrams (mg) of enteric coated (EC) darapladib, will specifically reduce the number of macrophages and/or result in a higher proportion of M2 macrophages in skin blisters induced by cantharidin (a chemical agent that causes blisters). In Part A of the study, a cohort of 8 subjects with type 2 diabetes mellitus will be recruited. In Part B of the study, a cohort of 8 additional healthy subjects with matching age (+/- 24 months) and gender to Part A may be recruited.
Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early...
Blebpurpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure . Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.
Comparing Recipient Site Preparation Using Dermabrasion, Dermaroller and Liquid Nitrogen Induced...
VitiligoA COMPARATIVE STUDY BETWEEN RECEPIENT SITE PREPARATION USING DERMABRASION, LIQUID NITROGEN INDUCED BLISTER AND DERMAROLLING SYSTEM IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS