comparison trial
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Author(s):  
Isaac B James ◽  
David M Turer ◽  
Barry E DiBernardo

Abstract Background Follicular unit extraction (FUE) hair transplantation subjects are excellent candidates to assess wound dressings. The wound surface area is large and adequately delineated to allow randomization, while in-patient split scalp designs allow patients to serve as their own controls. Objectives This randomized, single-blinded, split-scalp comparison trial compares a novel, film-forming silicone gel-- Stratamed (Stratpharma AG, Basel, Switzerland) -- to Bacitracin (McKesson Medical-Surgical Inc., Richmond, VA) in subjects undergoing FUE. Methods Twenty subjects were randomized to receive Stratamed and Bacitracin on alternating sides of the scalp. Primary outcome measures included blinded clinician assessments of edema, erythema, crusting, healing response and outcome preference. Secondary measures included subject-reported assessments of pain and pruritis as well as FaceQ scores taken at post-FUE days two through six. Results Twenty subjects were enrolled. Nineteen completed the trial. All subjects were non-smokers, and none had medical comorbidities expected to impact wound healing. An average of 1778 follicles per subject were harvested. No adverse events were reported, and all subjects healed by day 7. Healing response and outcome preference were significantly higher at day 1 in the Stratamed group and by day 7, both groups were similar. There were no significant differences between groups for edema, erythema, or crusting. There were no significant differences between groups for subject-reported outcomes of pain, pruritis, or FACE-Q scores. When asked which product they preferred using, 44% of subjects preferred using Stratamed versus 22% who preferred Bacitracin. Conclusions The Stratamed wound dressing was well-tolerated in patients undergoing FUE. Stratamed may speed the healing response in the early phase of wound healing.


2021 ◽  
Vol 10 (20) ◽  
pp. 4662
Author(s):  
Woo Hyun Paik ◽  
Joon Hyuk Choi ◽  
Yangsoon Park ◽  
Jung Bok Lee ◽  
Do Hyun Park

Background: EUS-guided fine-needle aspiration (EUS-FNA) has emerged as the primary modality for the cytologic diagnosis of pancreatic solid masses. The aim of this study is to determine whether technical factors including suction (S), non-suction (NS), capillary sampling with stylet slow-pull (CSSS), and the number of needle actuations (to-and-fro needle movements) may affect the accuracy of EUS-FNA for pancreatic solid masses at facilities without on-site cytopathology. Methods: The diagnostic yield of malignancy, blood contamination and cellularity at each sample acquired from EUS-FNA with or without S and different numbers of actuation (10, 15 and 20) were measured (study I). The optimal actuation number was determined and a head-to-head comparison trial between S and CSSS was performed (study II). Results: In study I, significant blood contamination was seen using S with 20 compared with 15 actuations (p = 0.002). Diagnostic yield of malignancy was not significantly different between 10, 15, and 20 actuations with S, whereas it was statistically higher for 15 actuations compared with 10 actuations with NS (p = 0.001). In study II, no difference was noted in diagnostic yield with 15 actuations between S and CSSS (88% vs. 90%, p = 0.74). Conclusions: Increasing actuation in NS resulted in a better diagnostic yield for EUS-FNA without significant blood contamination, whereas increasing actuation in S did not change the diagnostic yield of EUS-FNA while causing significant blood contamination. With 15 actuations, the diagnostic yield was comparable between S and CSSS.


2021 ◽  
pp. 106596
Author(s):  
Taishiro Kishimoto ◽  
Shotaro Kinoshita ◽  
Shogyoku Bun ◽  
Yasunori Sato ◽  
Momoko Kitazawa ◽  
...  

2021 ◽  
Author(s):  
Taishiro Kishimoto ◽  
Shotaro Kinoshita ◽  
Shogyoku Bun ◽  
Yasunori Sato ◽  
Momoko Kitazawa ◽  
...  

Introduction: The COVID-19 pandemic has had a profound impact on the mental health of people around the world. Anxiety related to infection, stress and stigma caused by the forced changes in daily life have reportedly increased the incidence and symptoms of depression, anxiety disorder and obsessive-compulsive disorder. Under such circumstances, telepsychiatry is gaining importance and attracting a great deal of attention. However, few large pragmatic clinical trials on the use of telepsychiatry targeting multiple psychiatric disorders have been conducted to date. Methods: The targeted study cohort will consist of adults (>18 years) who meet the DSM-5 diagnostic criteria for either (1) depressive disorders, (2) anxiety disorders, or (3) obsessive-compulsive and related disorders. Patients will be assigned in a 1:1 ratio to either a telepsychiatry group (at least 50% of visits to be conducted using telemedicine, with at least one face-to-face treatment [FTF] every six months) or an FTF group (all visits to be conducted FTF, with no telemedicine). Both groups will receive the usual treatment covered by public medical insurance. The study will utilize a master protocol design in that there will be primary and secondary outcomes for the entire group regardless of diagnosis, as well as the outcomes for each individual disorder group. Discussion: This study will be a non-inferiority trial to test that the treatment effect of telepsychiatry is not inferior to that of FTF alone. This study will provide useful insights into the effect of the COVID-19 pandemic on the practice of psychiatry.


10.2196/19770 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e19770
Author(s):  
Ayako Miyashita Ochoa ◽  
Christian Corpuz Paneda ◽  
Elizabeth SC Wu ◽  
Katherine Elizabeth Maxwell ◽  
Gerald Garth ◽  
...  

Background Black sexual minority men (BSMM) are disproportionately affected by HIV. Los Angeles County (LAC) carries a substantial burden of the HIV epidemic in California. Negative effects of both psychosocial and structural barriers highlight the timely need to increase HIV treatment among BSMM. Successful HIV interventions based on social media and mobile phone technology have been demonstrated. This protocol describes LINX LA, a study that tests LINX, a web-based mobile app that provides tailored social services, legal resources, and peer support for BSMM living with HIV (BSMM+) in LAC using a randomized comparison trial. Objective During phase 1, the LINX LA study aims to engage in an iterative design process to develop the LINX App using qualitative data to inform and tailor the mobile app technology and its functionality. In phase 2 of LINX LA, we will test the efficacy of the LINX App compared with the LINX App Plus to improve HIV treatment outcomes (ie, antiretroviral therapy adherence, viral suppression) among BSMM+ in LAC by addressing social work and legal needs and developing a forum for peer support. Methods In this study funded by the California HIV/AIDS Research Program, we will recruit and enroll BSMM+ participants (aged ≥18 years) in LAC (N=400) to participate in a 12-month study that includes access to the LINX App, which provides a forum for peer support and tailored content aimed at improving the use of social and legal resources. All participants will also receive survey-based interviews at 3 time points (at baseline and 6- and 12-month intervals) and weekly text message surveys that assess medication and treatment adherence. Treatment adherence and viral suppression will be extracted from medical record data. Half of the participants will also be randomly assigned to receive 3 individualized coaching sessions (at 1-, 3-, and 6-month intervals) and the ability to directly message their coach via the LINX App. Over the course of the study, LINX App participants will receive a minimum of US $130 in cash and LINX App Plus participants will receive a minimum of US $190. We hypothesize that participants enrolled in LINX App Plus will demonstrate greater improvement in HIV outcomes compared with LINX App participants. Results The LINX study will test the efficacy of a web-based mobile app intervention for BSMM+ in LAC (N=400). The LINX App seeks to increase participants’ knowledge of HIV; to facilitate access to necessary social and legal services, including information and referrals; and to increase social support across participants by providing a mediated forum for engagement. Conclusions The implementation of LINX LA aims to develop and test a culturally tailored approach to improve the HIV treatment outcomes of BSMM+. International Registered Report Identifier (IRRID) PRR1-10.2196/19770


2021 ◽  
Vol 17 (1) ◽  
pp. 51-61
Author(s):  
Zsolt Keserű ◽  
Attila Borovics ◽  
Tamás Ábri ◽  
Károly Rédei ◽  
Il Hwan Lee ◽  
...  

In the late 1990s, Hungarian Forest Research Institute researchers produced 15 micropropogated black locust (Robinia pseudoacacia L.) clones as part of a program to select clones that could be successfully grown on arid sites. Five of these clones (R.p. ‘Vacsi’, R.p. ‘Szálas’, R.p. ‘Oszlopos’, R.p. ‘Homoki’ and R.p. ‘Bácska’) have been categorized as cultivar candidates. The current study presents information concerning the ‘Bácska’, ‘Vacsi’ and ‘Homoki’ candidate cultivars. Based on research results obtained thus far, the three aforementioned candidate cultivars seem the most promising. The cultivars, aged 6-15 years, were tested in a variety comparison trial under arid, sandy soil conditions in the Danube–Tisza Interfluve near the town of Helvécia. Significant differences (p<0.05) were observed during results evaluation of full inventories and during the comparison of candidate cultivars partly with common black locust and partly with ‘Jászkiséri’ cultivars. The 15-yearold ‘Homoki’ outperformed common black locust in diameter and mean tree volume; ‘Vacsi’ outperformed in stem quality. The 14-year-old ‘Bácska’ candidate cultivar was compared with the ‘Jászkiséri’ cultivar and the ‘Oszlopos’ cultivar candidate. ‘Bácska’ proved to be significantly better in diameter and mean tree volume than Jászkiséri’, but weaker in trunk quality. The South Korean National Institute of Forest Science has supported this research for several years. The growing technology of the mentioned candidate cultivars are also examined in Korea, taking local ecological conditions into account.


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