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Introduction Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population.Methods and analysis AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8–12 years and myopia of −1 D to −6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months.Ethics and dissemination AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT03865160.

Although radial access is the current gold standard for the implementation of percutaneous coronary interventions (PCI), post-procedural radial compression devices are seldom compared with each other in terms of safety or efficacy. Our group aimed to compare a cost effective and potentially green method to dedicated radial compression devices, with respect to access site complications combined in a device oriented complex endpoint (DOCE), freedom from which served as our primary endpoint. Patients undergoing PCI were randomized to receive either the cost effective or a dedicated device, either of which were removed using patent hemostasis. Twenty-four hours after the procedure, radial artery ultrasonography was performed to evaluate the access site. The primary endpoint was assessed using a non-inferiority framework with a non-inferiority margin of five percentage points, which was considered as the least clinically meaningful difference. The cost-effective technique and the dedicated devices were associated with a comparably low rate of complications (freedom from DOCE: 83.3% vs. 70.8%, absolute risk difference: 12.5%, one-sided 95% confidence interval (CI): 1.11%). Composition of the DOCE (i.e., no complication, hematoma, pseudoaneurysm, and radial artery occlusion) and compression time were also assessed in superiority tests as secondary endpoints. Both the cost-effective technique and the dedicated devices were associated with comparably low rates of complications: p = 0.1289. All radial compression devices performed similarly when considering the time to complete removal of the respective device (120.0 (inter-quartile range: 100.0–142.5) for the vial vs. 120.0 (inter-quartile range: 110.0–180) for the dedicated device arm, with a median difference of [95% CI]: 7.0 [−23.11 to 2.00] min, p = 0.2816). In conclusion, our cost-effective method was found to be non-inferior to the dedicated devices with respect to safety, therefore it is a safe alternative to dedicated radial compression devices, as well as seeming to be similarly effective.

This research analyses the use of online learning media on the students’ achieved learning outcomes during the COVID-19 pandemic for 8th-grade students at PGRI 363 Pondok Petir. This research applies the descriptive method, which describes and interprets objects as what they are. The data in this research were collected by using observation, interview, and document. The findings of this research show that Google Classroom was used for online media learning for 8th-grade students at SMP PGRI 363. Using Google Classroom resulted in decreased and increased student learning outcomes. The outcome decreased in learning materials; not all students could absorb them. However, there was increasing skill. There is an increase in the skill aspect related to students’ skills in using technology in the field of learning, namely Google Classroom and according to information from teachers, it is stated that students have become more responsible for their learning, where students try to complete the tasks given even without direct supervision from the teacher in class. The results of teacher discussions with student parents during the learning review process using Google Classroom also show that students are becoming increasingly trained to be more independent in managing their learning at home.

Aphasia choirs have been gaining more and more attention for the last decade. The operation of these are based on two pillars: the therapeutic effect of singing with aphasia and decreasing the social isolation of clients with a verbal language disorder. The aim of this article is to draw attention to the international community of these choirs, with special focus on the Hungarian Aphasia Choir, and show their challenges resulting from the restrictions imposed by the SARS-CoV-2 pandemic. The Hungarian Aphasia Choir has had their therapeutic rehearsals online for seven months. The participants’ experiences and their coping methods regarding online and offline choir sessions were examined by an online survey of five questions completed by thirteen choir members living with aphasia as well as some of their caregivers. The responses clearly show the choir members’ general desire to carry on offline rehearsals, while the results also demonstrate that online rehearsals are effective in decreasing social isolation.

An abstract of the article "Novel Physical Methods for Nonviral DNA Transfer to Rabbit Retina," by Thomas W. Chalberg, Alexander Vankov, Philip Huie, Fanni E. Molnar, Michele P. Calos, and Daniel V. Palan is presented.

Purpose: The primary endpoint results from the comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity (CARE-ROP) core study identified ranibizumab as an effective treatment to control acute retinopathy of prematurity (ROP). This study reports the 1- and 2-year follow-up data focusing on long-term functional outcomes and safety., Methods: The CARE-ROP trial compared 0.12 mg versus 0.20 mg ranibizumab in 20 infants with ROP in a multicentric, prospective, randomized, double-blind, controlled study design. Sixteen patients entered the follow-up period. An ophthalmologic assessment at one year postbaseline was acquired from all 16 patients and a neurodevelopmental assessment at two years postbaseline was acquired from 15 patients., Results: Fifteen of 16 infants were able to fixate and follow moving objects at one year postbaseline treatment. One child progressed to stage 5 ROP bilaterally between the end of the core study and the 1-year follow-up (first seen at PMA 75 weeks). Mean spherical equivalents were -1.9 diopters (D) and -0.75 D in the 0.12 mg and the 0.20 mg treatment arms. Strabismus was present in seven and nystagmus in five out of 16 infants. Mental development scores were within normal limits in six out of ten patients with available data. No statistically significant difference was observed between the two treatment arms., Conclusion: Neurodevelopmental and functional ocular outcomes 1 and 2 years after treatment with ranibizumab are reassuring regarding long-term safety. Late reactivation of ROP, however, represents a challenge during the follow-up phase and it is of utmost importance that regular follow-ups are maintained., (© 2021 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

The female orgasm represents one of the most complex functions in the field of human sexuality. The conjunction of the anatomical, physiological, psycho-relational and socio-cultural components contributes to make the female orgasm still partly unclear. The female orgasmic experience, its correlates and the relation with sexual desire, arousal and lubrication as predictors are highly debated in scientific community. In this context, little is known about the impact of female sexual dysfunction (SD) on sexual pleasure expressed by subjective orgasmic intensity, and there are no suitable psychometric tools suited to investigate this dimension. Thus, we validate, in female subjects, a Visual Analogue Scale (VAS) that we named Orgasmometer-F, to verify if SD is accompanied by a lower perceived orgasmic intensity. A total of 526 women, recruited through a web-based platform and from sexological outpatient clinic, were enrolled in the study. They were divided into, on the basis of the Female Sexual Function Index (FSFI) score in two groups: 1) 112women suffering from SD, (SD Group); and 2) 414 sexually healthy women (Control Group). The participants were requested to fill out the Orgasmometer-F, recording orgasmic intensity on a Likert scale from 0 (absence of orgasmic intensity) to 10 (maximum orgasmic intensity experienced). Women with SD experienced significantly lower orgasmic intensity than controls, as measured by the Orgasmometer-F (p < 0.0001). Interestingly, masturbatory frequency was positively correlated with orgasmic intensity, as were the lubrication, orgasm and sexual satisfaction domains of the FSFI. The Orgasmometer-F was well understood, had a good test-retest reliability (ICC = 0.93) and a high AUC in differentiating between women with and without sexual dysfunction (AUC = 0.9; p < 0.0001). The ROC curve analysis showed that a cut-off <5 had 86.5% sensitivity (95% CI 82,8-89,6), 80.4% specificity (95% CI 71.8-87.3), 75.4% positive predictive value (PPV) and 89.5% negative predictive value (NPV). In conclusion, the Orgasmometer-F, a new psychometrically sound tool for measuring orgasmic intensity in female population, demonstrated that SD impair orgasmic intensity., Competing Interests: The authors have declared that no competing interests exist.

Context: To date, there are few studies investigating the impact of body changes induced by cross-sex hormonal treatment (CHT) on psychobiological well-being in gender-dysphoric persons (GDs)., Objective: The objective of the study was to assess whether CHT-related body changes affect psychobiological well-being in GDs., Methods: A consecutive series of 359 GDs was considered for a cross-sectional section of the study. In addition, 54 GDs were studied in a 2-year follow-up. A physical examination was performed, including body mass index, waist circumference, and hair distribution. We also evaluated breast development and testis volume in male to female subjects and clitoris length in female to male. Subjects were asked to complete several psychometric measures for the assessment of body uneasiness, GD, and psychopathology levels. The evaluation was repeated 2 years prospectively., Results: The following results were found: 1) GDs undergoing CHT reported significantly lower subjective levels of GD, body uneasiness, and depressive symptoms as compared with those without; 2) CHT-induced body modifications were significantly associated with a better psychological adjustment; 3) during CHT, GDs reported a significant reduction of general psychopathology, depressive symptoms, and subjective GD, whereas social and legal indicators of GD showed a significant increase across time; and 4) among body changes induced by CHT, only breast development and increased body mass index had a significant impact on psychopathology reduction across time in male to female subjects and female to male subjects, respectively., Conclusions: The aforementioned results support the efficacy of CHT intervention in improving subjective perception of one's own body, which was partially associated with objective changes.

Introduction: The relation between sexual and cardiovascular health in women is not well defined. Clitoral color Doppler ultrasound (CDU) with assessment of the pulsatility index (PI), reflecting resistance to blood flow, has been proposed as an objective measurement of sexual functioning., Aim: To investigate associations between clitoral PI and cardiometabolic risk factors, sexual and intrapsychic parameters, and self-perception of body image., Methods: Seventy-one adult heterosexual women in a stable relationship attending our clinic for sexual dysfunction were consecutively recruited., Main Outcome Measures: Patients underwent physical, laboratory, and clitoral color Doppler ultrasound examinations and completed the Female Sexual Function Index, the Middlesex Hospital Questionnaire, and the Body Uneasiness Test (BUT)., Results: Clitoral PI was positively correlated with body mass index (r = 0.441, P < .0001), waist circumference (r = 0.474, P < .0001), glycemia (r = 0.300, P = .029), insulin (r = 0.628, P = .002), homeostatic model assessment index (r = 0.605, P = .005), triglycerides (r = 0.340, P = .011), total cholesterol (r = 0.346, P = .010), and low-density lipoprotein cholesterol (r = 0.334, P = .016). All relations, with the exception of glycemia, retained statistical significance after adjusting for age, smoking habit, and years since menopause (P < .0001 for body mass index, waist circumference, and triglycerides; P < .05 for all other associations). Analysis of covariance, after adjusting for confounders, showed that women with obesity or metabolic syndrome (MetS) showed significantly higher PI values (obesity: F = 17.79, P = .001; MetS: F = 7.37, P = .019). In particular, a stepwise increase of PI was found as a function of increasing MetS components (β = 0.434, P = .007). Clitoral PI was negatively associated with Female Sexual Function Index arousal (β = -0.321, P = .014) and satisfaction (β = -0.289, P = .026) scores and positively associated with Middlesex Hospital Questionnaire somatized anxiety symptoms, even after adjusting for age, smoking habit, years since menopause, and current use of psychiatric medication (β = 0.354, P = .011). A positive association also was observed between PI and the BUT positive symptom distress index (β = 0.322, P = .039) and BUT for dislike of the womb, genitals, and breast (β = 0.538, P < .0001; β = 0.642, P < .0001; β = 0.549, P < .0001, respectively). After introducing waist circumference as another covariate, the associations between clitoral PI and the BUT positive symptom distress index and BUT dislike of the womb, genitals, and breast retained statistical significance (P = .038 for positive symptom distress index; P < .0001 for dislike of womb, genitals, and breast)., Conclusion: Clitoral vascular resistance is positively associated with MetS (in particular insulin resistance), decreased sexual arousal, body image concerns, and increased somatized anxiety symptoms. Further studies are needed to establish whether treatment of metabolic abnormalities might improve clitoral color Doppler ultrasound indices and sexual outcomes., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: Attitudes toward masturbation are extremely varied, and this practice is often perceived with a sense of guilt., Aim: To evaluate the prevalence of ego-dystonic masturbation (EM), defined as masturbation activity followed by a sense of guilt, in a clinical setting of sexual medicine and the impact of EM on psychological and relational well-being., Methods: A series of 4,211 men attending an andrology and sexual medicine outpatient clinic was studied retrospectively. The presence and severity of EM were defined according to ANDROTEST items related to masturbation, determined by the mathematical product of the frequency of masturbation and the sense of guilt after masturbation., Main Outcome Measures: Clinical, biochemical, and psychological parameters were studied using the Structured Interview on Erectile Dysfunction, ANDROTEST, and modified Middlesex Hospital Questionnaire., Results: Three hundred fifty-two subjects (8.4%) reported any sense of guilt after masturbation. Subjects with EM were younger than the remaining sample (mean age ± SD = 51.27 ± 13.43 vs 48.31 ± 12.04 years, P < .0001) and had more psychiatric comorbidities. EM severity was positively associated with higher free-floating (Wald = 35.94, P < .001) and depressive (Wald = 16.85, P < .001) symptoms, and subjects with a higher EM score reported less phobic anxiety (Wald = 4.02, P < .05) and obsessive-compulsive symptoms (Wald = 7.6, P < .01). A higher EM score was associated with a higher alcohol intake. Subjects with EM more often reported the partner's lower frequency of climax and more problems achieving an erection during sexual intercourse. EM severity was positively associated with worse relational and intrapsychic domain scores., Conclusion: Clinicians should consider that some subjects seeking treatment in a sexual medicine setting might report compulsive sexual behaviors. EM represents a clinically relevant cause of disability, given the high level of psychological distress reported by subjects with this condition, and the severe impact on quality of life in interpersonal relationships., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: An important feature of somatic symptom disorder is the subjective perception of the physical symptoms and its maladaptive interpretation. Considering that psychological distress is often expressed through somatic symptoms, it is possible that they underlie at least a part of the symptoms in subjects complaining of sexual dysfunction. Nevertheless, studies on the impact of somatoform disorders in sexual dysfunction are scanty., Aim: To define the psychological, relational, and organic correlates of somatic symptoms in a large sample of patients complaining of sexual problems., Methods: A consecutive series of 2833 men (mean age 50.2 ± 13.5 years) was retrospectively studied., Main Outcome Measures: Somatic symptoms were assessed using the "somatized anxiety symptoms" subscale of the Middlesex Hospital Questionnaire (MHQ-S). Several clinical, biochemical, psychological, and relational parameters were studied. Patients were interviewed with the previously validated Structured Interview on Erectile Dysfunction (SIEDY), and ANDROTEST (a structured interview for the screening of hypogonadism in patients with sexual dysfunction)., Results: Among the 2833 patients studied, subjects scoring higher on somatic symptoms were older, more obese, reporting unhealthy lifestyle (current smoking, alcohol consumption), and a lower education (all P < .05). Moreover, they reported a general impairment of their sexuality more often, including erectile problems (spontaneous or sexual-related), low sexual desire, decreased frequency of intercourse, and perceived reduction of ejaculate volume (all P < .005). Interestingly, we observed a significant association between MHQ-S scoring with a reduced testosterone level and hypogonadism symptoms (both P < .05). Finally, we found a significant association between somatic symptoms and both SIEDY Scales 1 (organic domain of ED) and 3 (intrapsychic domain of ED) (both P < .0001)., Conclusion: The present study demonstrates that the presence of somatic symptoms can represent an important contextual factor in the determination of or in the exacerbation of male sexual dysfunction. High levels of somatic symptoms in subjects with sexual dysfunction can be related to the sexual symptom itself. The consequences of this pattern have great clinical relevance in a sexual medicine setting, considering their severe impact on sexuality., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: The deterioration of a couple's relationship has been previously associated with impairment in male sexual function. Besides a couple's dystonic relationship, other stressors can unfavorably influence dyadic intimacy. A largely neglected etiopathogenetic factor affecting couple sexuality is the frustration caused by conflicts within the family., Aim: To evaluate the possible associations between male sexual dysfunction (SD) and conflictual relationships within the couple or the family., Methods: A consecutive series of 3,975 men, attending the Outpatient Clinic for SD for the first time, was retrospectively studied. Conflicts within the family and within the couple were assessed using two standard questions: "Are there any conflicts at home," and "Do you have a difficult relationship with your partner?" respectively, rating 0 = normal relationships, 1 = occasional quarrels, and 2 = frequent quarrels or always., Main Outcome Measures: Several clinical, biochemical, and psychological (Middlesex Hospital Questionnaire) parameters were studied., Results: Among the 3,975 patients studied, we observed a high prevalence of conflicts within the family and within the couple (32% vs. 21.2%). When compared with the rest of the sample, subjects reporting both type of conflicts showed a higher prevalence of psychiatric comorbidities. Hence, all data were adjusted for this parameter and for age. Family and couple conflicts were significantly associated with free floating anxiety, depression symptoms, and with a higher risk of subjective (self-reported) and objective (peak systolic velocity at the penile color Doppler ultrasound <35 mm/sec2) erectile dysfunction and hypoactive sexual desire. Female sexual function parameters, as reported by the patient, retained a significant association with both type of conflicts., Conclusions: This study indicates that the presence of often unexplored issues, like conflicts within the family or within the couple, can represent an important contextual factor in the determinism of male SD., (© 2015 International Society for Sexual Medicine.)

Introduction: An increased risk of autistic traits in Klinefelter syndrome (KS) has been reported. In addition, some studies have shown an increased incidence of gender dysphoria (GD) and paraphilia in autism spectrum disorder., Aim: The aim of this study was to evaluate the presence of (i) paraphilic fantasies and behaviors; and (ii) GD symptomatology in KS., Methods and Main Outcomes Measures: A sample of 46 KS individuals and 43 healthy male controls (HC) were evaluated. Subjects were studied by means of several psychometric tests, such as Autism Spectrum Quotient (AQ) and Reading the Mind in the Eyes Revised (RME) to measure autistic traits, Gender Identity/GD questionnaire (GIDYQ-AA), and Sexual Addiction Screening Test (SAST). In addition, body uneasiness psychopathological symptoms were assessed using Symptom Checklist 90 Revised (SCL-90-R). The presence and frequency of any paraphilic fantasy and behavior was assessed by means of a clinical interview based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria. Finally, all individuals included were assessed by Wechsler Adult Intelligence Scale-Revised to evaluate intelligence quotient (IQ). Data from a subsample of a previous published series of male to female GD individuals, with the battery of psychological measures useful to provide a psychopathological explanation of GD in KS population available, was also considered., Results: When compared with HC, KS reported significantly lower total, verbal and performance IQ scores and higher SCL-90 obsession-compulsive symptoms (all P < 0.001). In line with previously reported findings, KS showed higher autistic traits according with both RME and AQ tests (P < 0.001). With respect to sexuality, KS showed a significant higher frequency of voyeuristic fantasies during masturbation (52.2% vs. 25.6%) and higher SAST scores (P = 0.012). A mediation role of obsessive symptoms on the relationship between Klinefelter and SAST was confirmed (unstandardized estimate b = 2.75, standard error = 0.43 P < 0.001). Finally, KS individuals showed significantly higher gender dysphoric symptoms than HC (P = 0.004), which were mediated by the presence of autistic traits (Sobel's test; P < 0.05)., Conclusions: KS is associated with hypersexuality, paraphilic behaviors, and GD, which were mediated by obsessive-compulsive and autistic traits., (© 2015 International Society for Sexual Medicine.)