scholarly journals Defining lesional, perilesional and unaffected skin in hidradenitis suppurativa: proposed recommendations for clinical trials and translational research studies

2019 ◽  
Vol 181 (6) ◽  
pp. 1339-1341 ◽  
Author(s):  
J.W. Frew ◽  
K. Navrazhina ◽  
A.S. Byrd ◽  
A. Garg ◽  
J.R. Ingram ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Translational Research ◽  
Hidradenitis Suppurativa ◽  
Unaffected Skin ◽  
Research Studies

scholarly journals FRI0226 OPTICAL COHERENCE TOMOGRAPHY OF THE SKIN DETECTS SCLERODERMA CHANGES IN CLINICALLY UNAFFECTED SKIN: AN OPPORTUNITY FOR EARLY DETECTION OF SYSTEMIC SCLEROSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 696.2-696
Author(s):  
G. Abignano ◽  
D. Temiz Karadağ ◽  
O. Gundogdu ◽  
G. Lettieri ◽  
M. C. Padula ◽  
...  
Keyword(s):  
At Risk ◽  
Clinical Trials ◽  
Optical Coherence Tomography ◽  
Systemic Sclerosis ◽  
Early Detection ◽  
Classification Criteria ◽  
Healthy Controls ◽  
Optical Coherence ◽  
Risk Patients ◽  
Unaffected Skin

Background:The Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) study has shown that 82% of patients with Raynaud’s Phenomenon, specific ANA positivity and scleroderma pattern at nail fold videocapillaroscopy will fulfil classification criteria within 5 years. This is suggesting that there is a subclinical window of opportunity to diagnose systemic sclerosis (SSc) before clinical manifestations occur. In this scenario, a non-invasive tool to diagnose SSc in clinically unaffected skin might improve the early detection of disease in at risk-patients. Optical coherence tomography (OCT) of the skin has been shown to be a sensitive and accurate biomarker of skin fibrosis in SSc.Objectives:Here we aimed to assess the ability of skin OCT to “detect” SSc in clinically unaffected skin from a multicentre cohort.Methods:Dorsal forearm skin of SSc patients and matched-healthy controls (HC) was evaluated using VivoSight scanner (Michelson Diagnostics). Mean A-scans (mean OCT signal plotted against depth-in-tissue) were derived as previously described. Minimum Optical Density (MinOD), Maximum OD (MaxOD) and OD at 300 micron-depth (OD300) were calculated. Clinical involvement was assessed by an operator blinded to OCT findings using the mRSS. Receiver-operating characteristic (ROC) curve analysis was carried out for MinOD, MaxOD, and OD300 to evaluate their ability to discriminate between SSc and HC. Statistical analysis was performed using GraphPad Prism software V.7.0.Results:One hundred seventy four OCT images were collected from 87 subjects [43 SSc (39 Female, mean age 49.7±9.1 years) and 44 gender/age-matched healthy controls (HC) (36 Female, mean age 50.2±8.3 years)] in two different SSc centres. All patients fulfilled classification criteria for SSc. OCT measures demonstrated discriminative ability in SSc skin detection with any clinical skin involvement (0-3 at site of analysis) with an AUC of 0.73 (MinOD, 95%CI 0.64-0.81), 0.77 (MaxOD, 95%CI 0.7-0.85) and 0.82 (OD300, 95%CI 0.76-0.89); p<0.0001 for all as previously indicated. Most importantly, all three measures showed comparable performance in detecting scleroderma also in clinically unaffected skin (mRss=0 at site of analysis), with an AUC of 0.7 (95%CI 0.6-0.81, p=0.001), 0.72 (95%CI 0.61-0.83, p=0.0003) and 0.72 (95%CI 0.61-0.83, p=0.0003) for MinOD, MaxOD and OD300 respectively.Conclusion:Virtual biopsy by OCT recognises clinically unaffected skin of SSc patients from the HC skin. This is consistent with gene array data showing that scleroderma specific signatures are consistent in affected and clinically unaffected skin. These results inform future studies on at risk patients with clinically unaffected skin which may define a role for OCT in detecting subclinical SSc.Disclosure of Interests:Giuseppina Abignano: None declared, Duygu Temiz Karadağ: None declared, Ozcan Gundogdu: None declared, Giovanni Lettieri: None declared, Maria Carmela Padula: None declared, Angela Padula: None declared, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Salvatore D’Angelo: None declared, Francesco Del Galdo: None declared

scholarly journals Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stefan Rennick-Egglestone
Keyword(s):  
Social Media ◽  
Clinical Trials ◽  
Health Research ◽  
Online Intervention ◽  
Ethics Committee ◽  
Promotional Material ◽  
Media Campaigns ◽  
Social Media Platforms ◽  
Ethical Oversight ◽  
Research Studies

AbstractSome health research studies recruit participants through electronic mechanisms such as the placement of messages on social media platforms. This raises questions for ethics committee oversight, since effective social media campaigns might involve the production and dissemination of hundreds of contemporaneous messages. For the Narrative Experiences Online (NEON) study, we have developed nine principles to control the production and dissemination of promotional material. These have been approved by an ethics committee and enable the audit of our recruitment work. We propose that the drafting for approval of recruitment principles by health research studies may, in many cases, strike an appropriate balance between enabling ethical oversight of online recruitment work and the potential burden of message review.

The Eruption Patterns of The Teeth of Nigerian Local Pigs. Part 1: Profile of Deciduous Teeth

2021 ◽  
Author(s):  
Michael Efeturi Okandeji ◽  
Ayodeji David Lijoka ◽  
Folusho Ayobami Atiba ◽  
James Olukayode Olopade
Keyword(s):  
Animal Models ◽  
Translational Research ◽  
Deciduous Teeth ◽  
Translation Research ◽  
Dental Research ◽  
Dental Eruption ◽  
The Family ◽  
Local Pigs ◽  
Research Studies

Abstract Background: The pigs, domesticated about 6000 years ago, are highly prolific omnivores belonging to the Family Suidae and Order artiodactyla along with their other hooved counterparts. They qualify as models for various translational research studies (including dental studies) because of their anatomical and physiological similarities to humans. There is however a dearth of information as regards the deciduous dental eruption profile (sequence and timing of eruption) of the Nigerian local pigs (NLP). This study was designed to determine the deciduous eruption profile in the NLP to assist in the management of the breed and in a bid to making the NLP more obvious as suitable animal models in dental research. A total of 51 healthy piglets (from postnatal day 1) were used for this. Their oral cavities were examined every other day for 29 weeks for signs of dental eruption. Looking at Mandibular (Md) and Maxillar (Mx) eruptions for Incisors (I), Canines(C), Premolars (P) and Molars (M), the modular sequence in the NIP was Md/ Mx I3(at birth), C (at birth) →Md I1→Md P3→MxP3 →MxI1 → Md I2 →MdP4 →MxP4 →MxP2→ Md I2 →MxI2 . Result: It was observed that variations in eruption timing exist amongst individuals and sexes while variation in eruption sequence exists between NLP and various breeds of pigs based on the literature.Conclusion: The results of this study will be particularly important to farmers, and researchers into NLP especially those using pigs in Nigeria as a model for translation research.

scholarly journals 2520

2017 ◽  
Vol 1 (S1) ◽  
pp. 82-82
Author(s):  
Meghan Spiroff ◽  
Lisa Connally ◽  
Anita Johnson ◽  
Aalap Doshi ◽  
Patricia Piechowski
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Health Research ◽  
Participant Recruitment ◽  
Gender And Age ◽  
Study Population ◽  
Gender And Age Differences ◽  
The University ◽  
Racial Ethnic ◽  
Research Studies

OBJECTIVES/SPECIFIC AIMS: Across the Clinical and Translational Science Award (CTSA) Consortium, participant recruitment into clinical trials is essential to advance science. Without proper participant recruitment, clinical trials do not result in gains in scientific knowledge, wastes time, funds, and other resources (Mahon et al., 2015). METHODS/STUDY POPULATION: Participant recruitment programs across the consortium are inconsistent in staffing, program services, and program goals. The participant recruitment program at the University of Michigan’s (U-M) Michigan Institute for Clinical & Health Research (MICHR) provides expertise, tools, and resources to facilitate participant recruitment in clinical and health research studies. RESULTS/ANTICIPATED RESULTS: We will explain our program infrastructure, staffing, services, and discuss how we maintain an engaged registry with over 27,000 participants interested in research studies at U-M. DISCUSSION/SIGNIFICANCE OF IMPACT: Proper recruitment into clinical trials results in findings that are relevant for genetic, cultural, linguistic, racial/ethnic, gender, and age differences (Cottler et al., 2013). We hope to share our best practices that aid in the development and success of participant recruitment across the CTSA Consortium.

scholarly journals An Introduction to Pathology in Biomedical Research: A Mission-Critical Specialty for Reproducibility and Rigor in Translational Research

ILAR Journal ◽  
2018 ◽  
Vol 59 (1) ◽  
pp. 1-3 ◽  
Author(s):  
Cory F Brayton ◽  
Kelli L Boyd ◽  
Jeffrey L Everitt ◽  
David K Meyerholz ◽  
Piper M Treuting ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Translational Research ◽  
Study Design ◽  
Biomedical Research ◽  
Digital Pathology ◽  
Molecular Techniques ◽  
Device Development ◽  
Nonhuman Animals ◽  
Academic Settings ◽  
Mission Critical

Abstract This issue of ILAR Journal focusses on pathology and pathologists in biomedical research, more specifically in preclinical translational research involving (nonhuman) animals, emphasizing academic settings. Considerations in study design and planning to maximize benefit from pathologists and pathology resources are reviewed. Adjunctive technologies including molecular techniques, digital pathology, and imaging are highlighted. Additional considerations regarding safety and regulatory concerns, and veterinary clinical trials are reviewed as well. Pathology has been fundamental to understanding clinical disease, remains fundamental to diagnosing disease, and is required in drug and device development. Broader integration of pathology expertise and well-designed pathology investigations have much to offer research rigor and reproducibility, and successful translation from biomedical research.

scholarly journals The Future of Restorative Neurosciences in Stroke: Driving the Translational Research Pipeline From Basic Science to Rehabilitation of People After Stroke

2008 ◽  
Vol 23 (2) ◽  
pp. 97-107 ◽  
Author(s):  
◽  
Binith Cheeran ◽  
Leonardo Cohen ◽  
Bruce Dobkin ◽  
Gary Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Translational Research ◽  
Basic Science ◽  
Clinical Importance ◽  
Small Scale ◽  
Front Line ◽  
Pressure Groups ◽  
The United Kingdom ◽  
Public Sector Research

Background. Major advances during the past 50 years highlight the immense potential for restoration of function after neural injury, even in the damaged adult human brain. Yet, the translation of these advances into clinically useful treatments is painstakingly slow. Objective. Here, we consider why the traditional model of a “translational research pipeline” that transforms basic science into novel clinical practice has failed to improve rehabilitation practice for people after stroke. Results. We find that (1) most treatments trialed in vitro and in animal models have not yet resulted in obviously useful functional gains in patients; (2) most clinical trials of restorative treatments after stroke have been limited to small-scale studies; (3) patient recruitment for larger clinical trials is difficult; (4) the determinants of patient outcomes and what patients want remain complex and ill-defined, so that basic scientists have no clear view of the clinical importance of the problems that they are addressing; (5) research in academic neuroscience centers is poorly integrated with practice in front-line hospitals and the community, where the majority of patients are treated; and (6) partnership with both industry stakeholders and patient pressure groups is poorly developed, at least in the United Kingdom where research in the translational restorative neurosciences in stroke depends on public sector research funds and private charities. Conclusions. We argue that interaction between patients, front-line clinicians, and clinical and basic scientists is essential so that they can explore their different priorities, skills, and concerns. These interactions can be facilitated by funding research consortia that include basic and clinical scientists, clinicians and patient/carer representatives with funds targeted at those impairments that are major determinants of patient and carer outcomes. Consortia would be instrumental in developing a lexicon of common methods, standardized outcome measures, data sharing and long-term goals. Interactions of this sort would create a research-friendly, rather than only target-led, culture in front-line stroke rehabilitation services.

Sign in / Sign up

Export Citation Format

Share Document