The present clinical trial was conducted to obtain additional data for the safety and efficacy of a head lice shampoo that is free of silicone compared with an anti-head lice product containing dimethicone. Both products act by a physical mode of action. This randomized, investigator-blinded, controlled clinical study was conducted between July and November 2016 in households of two villages (Abou Rawash and Shandalat) in Egypt. Children older than 2 years with an active head lice infestation were treated with either a shampoo-based head lice treatment containing neem extract (Licener®) or dimethicone (Jacutin® Pedicul Fluid) on day 1 and additionally on day 9. Assessment for living lice by combing was conducted before and 1-2 h after treatment and on days 5 and 13. The main objective was to demonstrate a cure rate of the test product of at least 85% after a single application (day 5 and 9). Secondary objectives were to scrutinize patient safety and satisfaction as well as cure rates on day 13 after two treatments and the evaluation of ovicidal and licicidal efficacies of the products. Sixty-one children in the test-group (Licener®) and 58 children in the reference group (Jacutin® Pedicul Fluid) were included in this study. The test product and the reference product were very well tolerated. Both products exceeded the objective of cure rates of over 85% after single treatment (test group 60/60 = 100%; 95% CI = 94.04-100.00%; reference group 54/57 = 94.74%; 95% CI = 85.38-98.90%; p = 0.112; CI by Clopper-Pearson) and after two treatments (test group 58/58 = 100%; 95% CI = 93.84-100.00%; reference group 52/54 = 96.30%; 95% CI = 87.25-99.55%; p = 0.230) with higher cure rates and non-inferiority for the test product. The combined success rate shows significant superiority of the test product against the reference product (test group 58/58 = 100%; 95% CI = 93.84-100.00%; reference group 49/54 = 90.7%; 95% CI = 79.70-96.92%; p = 0.024). The test product showed higher ovicidal efficacy than the reference product. Thus, the present study demonstrates that a single treatment with a head lice product like Licener® can be sufficient to eliminate a head lice infestation.
Introduction: Surgeons are among the most at-risk professionals for work-related musculoskeletal decline and experience high mental demands. This study examined the electromyographic (EMG) and electroencephalographic (EEG) activities of surgeons during surgery. Methods: Surgeons who performed live laparoscopic (LS) and robotic (RS) surgeries underwent EMG and EEG measurements. Wireless EMG was used to measure muscle activation in 4 muscle groups bilaterally (biceps brachii, deltoid, upper trapezius, and latissimus dorsi), and an 8-channel wireless EEG device was used to measure cognitive demand. EMG and EEG recordings were completed simultaneously during (1) noncritical bowel dissection, (2) critical vessel dissection, and (3) dissection after vessel control. Robust ANOVA was used to compare the %MVCRMS and alpha power between LS and RS. Results: Thirteen male surgeons performed 26 LS and 28 RS. Muscle activation was significantly higher in the right deltoid (P = 0.006), upper trapezius (left, P = 0.041; right, P = 0.032), and latissimus dorsi (left, P = 0.003; right, P = 0.014) muscles in the LS group. There was greater muscle activation in the right biceps than in the left biceps in both surgical modalities (both P = 0.0001). There was a significant effect of the time of surgery on the EEG activity (P < 0.0001). A significantly greater cognitive demand was observed in the RS than in the LS with alpha, beta, theta, delta, and gamma (P = 0.002 – P <0.0001). Conclusions: These data suggest greater muscle demands in laparoscopic surgery, but greater cognitive demands in RS. This trial was registered at Clinicaltrials.gov (NCT04477746).
Head lice infections are a growing problem in the light of increasing migration of large population as well as the increasing current refugee flows and concomitant poor hygienic conditions. These infections are associated with a significantly reduced quality of life and frequent medical consultations. The approved drugs for the treatment of head lice infections have some disadvantages in the treatment despite their good efficacy. In addition to irritant-toxic substances that can cause adverse reactions in patients, a partial development of resistance has occurred and a double application is necessary to achieve adequate efficacy. For this reason, we have decided to test a product without the aforementioned treatment drawbacks. We examined the effect of Licener® on the head lice treatment through individual therapy trials. We identified 65 patients with head lice infections for the treatment with Licener®. All patients were treated with Licener® and visited for a period of 2 weeks. Successfully treated patients had no relapses. Against the background of this study and based on the observations of our applications, we expect that Licener® could enhance considerably the therapeutic options for the treatment of head lice infections, as an alternative to classical products.
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