ObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.Main outcome measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up.ResultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.ConclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures.Trial registrationClinicalTrials.gov NCT01200277.

Background The coronavirus disease 2019 (COVID-19) pandemic had brought negative consequences and new stressors to mothers. The current study aims to compare factors predicting maternal mental health during the COVID-19 lockdown in China, Italy, and the Netherlands. Methods The sample consisted of 900 Dutch, 641 Italian, and 922 Chinese mothers (age M = 36.74, s.d. = 5.58) who completed an online questionnaire during the lockdown. Ten-fold cross-validation models were applied to explore the predictive performance of related factors for maternal mental health, and also to test similarities and differences between the countries. Results COVID-19-related stress and family conflict are risk factors and resilience is a protective factor in association with maternal mental health in each country. Despite these shared factors, unique best models were identified for each of the three countries. In Italy, maternal age and poor physical health were related to more mental health symptoms, while in the Netherlands maternal high education and unemployment were associated with mental health symptoms. In China, having more than one child, being married, and grandparental support for mothers were important protective factors lowering the risk for mental health symptoms. Moreover, high SES (mother's high education, high family income) and poor physical health were found to relate to high levels of mental health symptoms among Chinese mothers. Conclusions These findings are important for the identification of at-risk mothers and the development of mental health promotion programs during COVID-19 and future pandemics.

Objective: Fear of cancer recurrence (FCR) is a common consequence of surviving cancer; therefore, easily accessible self-help training could help many cancer survivors deal with FCR at low costs. The CAncer REcurrence Self-help Training (CAREST) trial evaluates the effectiveness of an online-tailored self-help training on the basis of evidence-based cognitive behavioral therapy principles in breast cancer survivors.Also, possible predictors for benefitting from the online self-help training were examined.Methods: This multicenter randomized controlled trial included 262 female breast cancer survivors, randomly assigned to either online self-help training (n = 130) or care as usual (CAU; n = 132). Participants completed questionnaires at baseline (T0), 3 months (T1; after intervention), and 9 months (T2). The primary outcome was FCR (Fear of Cancer Recurrence Inventory Severity subscale). Both effectiveness and predictors were analyzed with latent growth curve modeling (LGCM) according to the intention-to-treat principle. Results:LGCM showed no differences between the average latent slope in both groups (χ 2 1 = .23, P = .63), suggesting that the treatments did not differ in their change in FCR over time. Moreover, no differences were found in the effects of the predictors on the latent slope in both groups (χ 2 1 = .12, P = .73), suggesting that no significant predictors were found for the effect of the intervention on FCR. Conclusion:There was no effect of the CBT-based online self-help training "Less fear after cancer" in the current study. Therefore, we recommend adding professional support to online interventions for FCR.

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Cancer cells have been found to frequently express genes that are normally restricted to the testis, often referred to as cancer/testis (CT) antigens or genes. Because germ cell-specific antigens are not recognized as “self” by the innate immune system, CT-genes have previously been suggested as ideal candidate targets for cancer therapy. The use of CT-genes in cancer therapy has thus far been unsuccessful, most likely because their identification has relied on gene expression in whole testis, including the testicular somatic cells, precluding the detection of true germ cell-specific genes. By comparing the transcriptomes of micro-dissected germ cell subtypes, representing the main developmental stages of human spermatogenesis, with the publicly accessible transcriptomes of 2617 samples from 49 different healthy somatic tissues and 9232 samples from 33 tumor types, we here discover hundreds of true germ cell-specific cancer expressed genes. Strikingly, we found these germ cell cancer genes (GC-genes) to be widely expressed in all analyzed tumors. Many GC-genes appeared to be involved in processes that are likely to actively promote tumor viability, proliferation and metastasis. Targeting these true GC-genes thus has the potential to inhibit tumor growth with infertility being the only possible side effect. Moreover, we identified a subset of GC-genes that are not expressed in spermatogonial stem cells. Targeting of this GC-gene subset is predicted to only lead to temporary infertility, as untargeted spermatogonial stem cells can recover spermatogenesis after treatment. Our GC-gene dataset enables improved understanding of tumor biology and provides multiple novel targets for cancer treatment.