HIHISIV: a database of gene expression in HIV and SIV host immune response.

In the battle of the host against lentiviral pathogenesis, the immune response is crucial. However, several questions remain unanswered about the interaction with different viruses and their influence on disease progression. The simian immunodeficiency virus (SIV) infecting nonhuman primates (NHP) is widely used as a model for the study of the human immunodeficiency virus (HIV) both because they are evolutionarily linked and because they share physiological and anatomical similarities that are largely explored to understand the disease progression. The HIHISIV database was developed to support researchers to integrate and evaluate the large number of transcriptional data associated with the presence/absence of the pathogen (SIV or HIV) and the host response (NHP and human). The datasets are composed of microarray and RNA-Seq gene expression data that were selected, curated, analyzed, enriched, and stored in a relational database. Six query templates comprise the main data analysis functions and the resulting information can be downloaded. The HIHISIV database, available at  https://hihisiv.github.io , provides accurate resources for browsing and visualizing results and for more robust analyses of pre-existing data in transcriptome repositories.

Hepatitis E virus prevalence among HIV-2 infected individuals in central Portugal.

To date, no studies comparing the prevalence of hepatitis E virus (HEV) infection between the general and human immunodeficiency virus 2 (HIV-2) populations are available. With the purpose of filling this gap, this prevalence was assessed in the HIV-2 population from central Portugal. HEV seropositivity was 19.4%, which did not differ significantly from that found in the matched control population, and was not associated with CD4 cell count, HIV-2 viral load, and geographic origin or travel history to regions considered highly endemic for HEV. The results suggest that HIV-2 is not a risk factor for HEV infection, neither for an increased occurrence of chronic HEV infection.

Unmet needs in mental healthcare for women with clinically significant symptoms of perinatal depression and/or anxiety during the COVID-19 pandemic.

OBJECTIVE/BACKGROUND: Unmet needs in perinatal mental healthcare are an important public health issue particularly in the context of a stressful life event such as the COVID-19 pandemic but data on the extent of this problem are needed. AIM: The aim of this study is to determine the (1) proportion of women with clinically significant symptoms of perinatal depression, anxiety or comorbid symptoms of depression and anxiety, receiving mental healthcare overall and by country and (2) factors associated with receiving mental healthcare. METHOD: Women in the perinatal period (pregnancy or up to 6 months postpartum) participating in the Riseup-PPD-COVID-19 cross-sectional study, reported on sociodemographic, social support health-related factors, and COVID-19 related factors, and on symptoms of depression (Edinburgh Postnatal Depression Scale [EPDS]) and anxiety (Generalised Anxiety Disorder [GAD-7]) using self-report questionnaires. Clinically significant symptoms were defined as EPDS ≥ 13 for depression and GAD-7 ≥ 10 for anxiety. Mental healthcare was defined as self-reported current mental health treatment. RESULTS: Of the 11 809 participants from 12 countries included in the analysis, 4 379 (37.1%) reported clinically significant symptoms of depression (n = 1 228; 10.4%; EPDS ≥ 13 and GAD-7 ⟨ 10), anxiety (n = 848; 7.2%; GAD-7 ≥ 10 and EPDS ⟨ 13) or comorbid symptoms of depression and anxiety (n = 2 303; 19.5%; EPDS ≥ 13 and GAD-7 ≥ 10). Most women with clinically significant symptoms of depression, anxiety, or comorbid symptoms of depression and anxiety were not receiving mental healthcare (89.0%). Variation in the proportion of women with clinically significant symptoms of depression and/or anxiety reporting mental healthcare was high (4.7% in Turkey to 21.6% in Brazil). Women in the postpartum (vs. pregnancy) were less likely (OR 0.72; 95% CI 0.59-0.88), whereas women with previous mental health problems (vs. no previous mental health problems) (OR 5.56; 95% CI 4.41-7.01), were more likely to receive mental healthcare. CONCLUSION: There are high unmet needs in mental healthcare for women with clinically significant symptoms of perinatal depression and/or anxiety across countries during the COVID-19 pandemic. Studies beyond the COVID-19 pandemic and covering the whole range of mental health problems in the perinatal period are warranted to understand the gaps in perinatal mental healthcare.

Trends in the quality of maternal and neonatal care in Sweden and Norway as compared to 12 WHO European countries: A cross-sectional survey investigating maternal perspectives during the COVID-19 pandemic.

INTRODUCTION: Maternal-neonatal healthcare services were severely disrupted during the COVID-19 pandemic in even high-income countries within the World Health Organization (WHO) European Region. The objective of this study was to compare trends in the quality of maternal and neonatal care (QMNC) in Sweden and Norway to 12 other countries from the WHO European Region during the COVID-19 pandemic, and to identify domains for improvement. MATERIAL AND METHODS: This cross-sectional study included women giving birth in Europe from March 1, 2020 to December 31, 2022. Women answered an online, anonymous questionnaire which included 40 WHO Standard-based Quality Measures collectively scored as the total QMNC index (0-400) and separately in four subdomains (0-100): provision of care, experience of care, availability of human and physical resources, and reorganizational changes due to COVID-19. To assess reported QMNC changes over time, we used adjusted quantile regression models. CLINICALTRIALS: gov Identifier: NCT04847336. RESULTS: Of the 45151 women included in the study, 13 117 (29.1%) were from Sweden and Norway and 32034 (70.9%) from the 12 WHO European countries. The total QMNC index for Sweden and Norway (median: 325, IQR: 285-355) was higher than the 12 WHO European countries (median: 315, IQR: 265-350, p < 0.001) as were trends in QMNC index over time (Sweden and Norway median: 310-345; 12 WHO European countries median: 305-340). Sweden and Norway also had higher scores in three-of-four QMNC subdomains, with the 12 WHO European countries scoring higher only for reorganizational changes due to COVID-19. In adjusted quantile models of the total QMNC index, Sweden and Norway had higher scores, with largest differences in the lower quantiles (p < 0.001 in all percentiles). CONCLUSIONS: Across Europe, there are significant gaps in the quality of maternal-neonatal healthcare services. Although women giving birth in Sweden and Norway reported higher QMNC scores in all subdomains except for "reorganizational changes due to COVID-19," there is room for improvement and shared learning across Europe. Policymakers should prioritize long-term investments in maternal and neonatal healthcare, ensuring that facilities are adequately equipped during public health crises and that all women have access to high-quality, evidence-based, equitable, and respectful care.

Seeking help for perinatal depression and anxiety: a systematic review of systematic reviews from an interdependent perspective.

BACKGROUND: Seeking help for perinatal mood and anxiety disorders is crucial for women's mental health and babies' development, yet many women do not seek help for their condition and remain undiagnosed and untreated. This systematic review of systematic reviews aimed at summarizing and synthesizing findings from all systematic reviews on seeking help for PMAD in the context of interdependence theory, highlighting the interdependent relationship between women and healthcare providers and how it may impact women's seeking-help process. METHODS: Four electronic databases were searched, and 18 studies published up to 2023 met inclusion criteria for review. RESULTS: The capability, opportunity and motivation model of behavior was used as a framework for organizing and presenting the results. Results demonstrate that seeking help for PMAD is a function of the interdependent relationship between perinatal women's and healthcare providers' psychological and physical capabilities, social and physical opportunities, and their reflective and automatic motivation. CONCLUSIONS: Unmet needs in perinatal mental healthcare is an important public health problem. This systematic review of systematic reviews highlights key factors for policymakers, researchers, and practitioners to consider to optimize healthcare systems and interventions in a way that enhances perinatal women's treatment whenever necessary.

Changes to women's childbirth plans during the COVID-19 pandemic and posttraumatic stress symptoms: a cross-national study.

A considerable number of women giving birth during COVID-19 pandemic reported being concerned about changes to their childbirth plans and experiences due to imposed restrictions. Research prior to the pandemic suggests that women may be more at risk of post-traumatic stress symptoms (PTSS) due to unmet expectations of their childbirth plans. Therefore, this study aimed to examine if the mismatch between women's planned birth and actual birth experiences during COVID-19 was associated with women's postpartum PTSS. Women in the postpartum period (up to 6 months after birth) across 11 countries reported on childbirth experiences, mental health, COVID-19-related factors, and PTSS (PTSD checklist DSM-5 version) using self-report questionnaires (ClinicalTrials.gov: NCT04595123). More than half (64%) of the 3532 postpartum women included in the analysis reported changes to their childbirth plans. All changes were significantly associated with PTSS scores. Participants with one and two changes to their childbirth plans had a 12% and 38% increase, respectively, in PTSS scores compared to those with no changes (Exp(ß) = 1.12; 95% CI [1.06-1.19]; p < 0.001 and Exp(ß) = 1.38; 95% CI [1.29-1.48]; p < 0.001). In addition, the effect of having one change in the childbirth plan on PTSS scores was stronger in primigravida than in multigravida (Exp(ß) = 0.86; 95% CI [0.77-0.97]; p = 0.014). Changes to women's childbirth plans during the COVID-19 pandemic were common and associated with women's postpartum PTSS score. Developing health policies that protect women from the negative consequences of unexpected or unintended birth experiences is important for perinatal mental health.

Association of child neurodevelopmental or behavioural problems with maternal unemployment in a population-based birth cohort.

PURPOSE: To estimate associations between suspected or diagnosed neurodevelopmental or behavioural problems in 7-year-old children and maternal unemployment at child age 7 and 10, in a Portuguese birth cohort. METHODS: We evaluated 5754 mothers and their children of the population-based birth cohort Generation XXI in Porto, Portugal. Data on suspected and diagnosed child neurodevelopmental and behavioural problems (exposures)-learning, attention and language problems, externalising behaviours, developmental delay, autism spectrum disorders, and other neurodevelopmental problems-were retrieved at 7 years of age by interviewing caregivers. Maternal employment status (outcome) was collected at the 7- and 10-year follow-up waves. Robust Poisson regression models were used to estimate associations. RESULTS: After adjustment for maternal and household characteristics, women were more likely to be unemployed at child age 10 if the child had, up to age 7, any of the following suspected problems: an autism spectrum disorder (PR = 1.73; 95% CI 1.07, 2.79), developmental delay (PR = 1.58; 95% CI 1.20, 2.06), externalising behaviours (PR = 1.29; 95% CI 1.11, 1.50) or learning problems (PR = 1.26; 95% CI 1.07, 1.48). When the exposure was restricted to clinically diagnosed disorders, the magnitude of associations remained similar but estimates were less precise. Associations with unemployment were stronger at child age 10 (prospective analyses), than at child age 7 (cross-sectional). CONCLUSION: Having a child with learning, developmental or behavioural problems, or an autism spectrum disorder up to age 7 was associated with maternal unemployment three years later, even in a less affluent European economy where the dual-earner family structure is often necessary to make ends meet.

Late-onset neonatal sepsis was not associated with impaired neurodevelopmental outcome: Results from the EPICE/SHIPS-PT cohort.

AIM: To assess the impact of late-onset neonatal sepsis (LONS) on the cognitive and motor development of five-year-old children who were born very preterm (VPT). METHODS: This study included 327 VPT children from the Portuguese EPICE/SHIPS cohort who attended the neurodevelopment assessment. Neuropsychological tests such as WPPSI-R, MABC-2 and NEPSY-II (language domain) were used to assess the children's cognitive and motor development. Statistical analysis was performed to compare the socio-demographic, clinical and neurodevelopment outcomes of VPT children with and without LONS. Regression analysis adjusted for confounding variables was performed when applicable. RESULTS: Underperformance in intelligence quotient and language development was similar regardless of a neonatal diagnosis of LONS. In contrast, VPT children with LONS had a higher risk of movement difficulties than those without LONS (p = 0.02). However, the association was lost after adjusting for confounders (ß = -0.25; p > 0.05). CONCLUSION: LONS per se was not associated with the risk for poor long-term cognitive or motor outcomes in VPT children. Social-demographic and clinical characteristics assessed during the neonatal period and at the time of neurodevelopment assessment were similar between groups suggesting that social-related factors such as parents' educational level could have mitigated the LONS impact.

Assessing mother's childbirth-related posttraumatic stress disorder during the first year postpartum: a systematic review.

BACKGROUND AND AIM: PTSD after childbirth is a significant but often under-recognised mental health problem. This systematic review aims to examine the measures used to assess childbirth-related PTSD (CB-PTSD) and posttraumatic stress symptoms (CB-PTSS) in mothers in the first year postpartum and to evaluate their psychometric properties. METHODS: Following PRISMA guidelines, a comprehensive search of multiple databases and grey literature sources was conducted. Studies that involved mothers in the first year postpartum and reported measures of CB-PTSD and/or CB-PTSS were included. Quality assessment was based on the CASP Checklist. RESULTS: 149 studies met the inclusion criteria. Self-report questionnaires, particularly the IES and its revisions, were the most commonly used measurement instruments. In recent years, however, specialised instruments such as the City Birth Trauma Scale have emerged that were developed specifically for assessing CB-PTSD. Psychometric properties varied from study to study, with some lacking detailed information on validity and reliability. CONCLUSION: The results emphasises the importance of using validated and tailored tools for the assessment of CB-PTSD. Whilst self-report questionnaires remain widely used, the development and use of specialised instruments such as the City BiTS provide greater precision in the assessment of CB-PTSD symptoms. Future research should focus on refining measurement tools, conducting longitudinal studies to explore symptom trajectories, and investigating the effectiveness of early intervention strategies. By refining measurement methods and intervention approaches, clinicians can better support mothers with CB-PTSD and ultimately fostering improve the mental health outcomes for both mothers and their families.

Risk factors for cerebral palsy and movement difficulties in 5-year-old children born extremely preterm.

BACKGROUND: Motor impairment is common after extremely preterm (EPT, <28 weeks' gestational age (GA)) birth, with cerebral palsy (CP) affecting about 10% of children and non-CP movement difficulties (MD) up to 50%. This study investigated the sociodemographic, perinatal and neonatal risk factors for CP and non-CP MD. METHODS: Data come from a European population-based cohort of children born EPT in 2011-2012 in 11 countries. We used multinomial logistic regression to assess risk factors for CP and non-CP MD (Movement Assessment Battery for Children - 2nd edition ≤5th percentile) compared to no MD (>15th percentile) among 5-year-old children. RESULTS: Compared to children without MD (n = 366), young maternal age, male sex and bronchopulmonary dysplasia were similarly associated with CP (n = 100) and non-CP MD (n = 224) with relative risk ratios (RRR) ranging from 2.3 to 3.6. CP was strongly related to severe brain lesions (RRR >10), other neonatal morbidities, congenital anomalies and low Apgar score (RRR: 2.4-3.3), while non-CP MD was associated with primiparity, maternal education, small for GA (RRR: 1.6-2.6) and severe brain lesions, but at a much lower order of magnitude. CONCLUSION: CP and non-CP MD have different risk factor profiles, with fewer clinical but more sociodemographic risk factors for non-CP MD. IMPACT: Young maternal age, male sex and bronchopulmonary dysplasia similarly increased risks of both cerebral palsy and non-cerebral palsy movement difficulties. Cerebral palsy was strongly related to clinical risk factors including severe brain lesions and other neonatal morbidities, while non-cerebral palsy movement difficulties were more associated with sociodemographic risk factors. These results on the similarities and differences in risk profiles of children with cerebral palsy and non-cerebral palsy movement difficulties raise questions for etiological research and provide a basis for improving the identification of children who may benefit from follow-up and early intervention.

Developmental motor problems and health-related quality of life in 5-year-old children born extremely preterm: A European cohort study.

AIM: To measure the association between cerebral palsy (CP) and non-CP-related movement difficulties and health-related quality of life (HRQoL) among 5-year-old children born extremely preterm (<28 weeks gestational age). METHOD: We included 5-year-old children from a multi-country, population-based cohort of children born extremely preterm in 2011 to 2012 in 11 European countries (n = 1021). Children without CP were classified using the Movement Assessment Battery for Children, Second Edition as having significant movement difficulties (≤5th centile of standardized norms) or being at risk of movement difficulties (6th-15th centile). Parents reported on a clinical CP diagnosis and HRQoL using the Pediatric Quality of Life Inventory. Associations were assessed using linear and quantile regressions. RESULTS: Compared to children without movement difficulties, children at risk of movement difficulties, with significant movement difficulties, and CP had lower adjusted HRQoL total scores (ß [95% confidence interval] = -5.0 [-7.7 to -2.3], -9.1 [-12.0 to -6.1], and - 26.1 [-31.0 to -21.2]). Quantile regression analyses showed similar decreases in HRQoL for all children with CP, whereas for children with non-CP-related movement difficulties, reductions in HRQoL were more pronounced at lower centiles. INTERPRETATION: CP and non-CP-related movement difficulties were associated with lower HRQoL, even for children with less severe difficulties. Heterogeneous associations for non-CP-related movement difficulties raise questions for research about mitigating and protective factors.

Prediction of movement difficulties at 5 years from parent report at 2 years in children born extremely preterm.

AIM: To assess the predictive validity of parent-reported gross motor impairment (GMI) at age 2 years to detect significant movement difficulties at age 5 years in children born extremely preterm. METHOD: Data were from 556 children (270 males, 286 females) born at less than 28 weeks' gestation in 2011 to 2012 in 10 European countries. Parent report of moderate/severe GMI was defined as walking unsteadily or unable to walk unassisted at 2 years corrected age. Examiners assessed significant movement difficulties (score ≤ 5th centile on the Movement Assessment Battery for Children, Second Edition) and diagnoses of cerebral palsy (CP) were collected by parent report at 5 years chronological age. RESULTS: At 2 years, 66 (11.9%) children had moderate/severe GMI. At 5 years, 212 (38.1%) had significant movement difficulties. Parent reports of GMI at age 2 years accurately classified CP at age 5 years in 91.0% to 93.2% of children. Classification of moderate/severe GMI at age 2 years had high specificity (96.2%; 95% confidence interval 93.6-98.0) and positive predictive value (80.3%; 68.7-89.1) for significant movement difficulties at age 5 years. However, 74.5% of children with significant movement difficulties at 5 years were not identified with moderate/severe GMI at age 2 years, resulting in low sensitivity (25.1%; 19.4-31.5). INTERPRETATION: This questionnaire may be used to identify children born extremely preterm who at age 2 years have a diagnosis of CP or movement difficulties that are likely to have a significant impact on their functional outcomes at age 5 years.

The effect of parenting behaviours on adolescents' rumination: a systematic review of longitudinal studies.

Rumination is an emotional regulation mechanism strongly associated with the development and maintenance of internalising psychopathology in adolescence and adulthood. Parenting behaviours (PBs) play a pivotal role in the development of rumination in children and adolescents. Nonetheless, the specific PBs that can either protect against or increase the risk of rumination development remain poorly understood. This systematic review aimed to explore the (1) temporal associations between PBs and adolescents' rumination and (2) potential moderators influencing these associations. We conducted a comprehensive search across Web of Science, Scopus, PubMed, Academic Search Complete and Eric databases, adhering to PRISMA reporting guidelines. Out of 1,868 abstracts screened, 182 articles underwent full-text examination, with nine meeting the inclusion criteria for the systematic review. Overall, the studies indicated that PBs characterised by criticism, rejection and control were positively associated with the development of rumination in adolescents, whilst PBs marked by authoritative practises exhibited a negative association with rumination. Gender, temperament, environmental sensitivity and pubertal timing emerged as significant moderators in the effects of PBs on rumination. However, conclusions were limited due to the studies' methodological heterogeneity. Future studies on PBs and rumination should address various dimensions of PBs and different moderators to identify factors that can modify the development of rumination across adolescence. Findings may inform family-based prevention programmes to promote emotion regulation in adolescents as a protective factor against internalising psychopathology across adulthood.

Tannic Acid Tailored-Made Microsystems for Wound Infection.

Difficult-to-treat infections make complex wounds a problem of great clinical and socio-economic impact. Moreover, model therapies of wound care are increasing antibiotic resistance and becoming a critical problem, beyond healing. Therefore, phytochemicals are promising alternatives, with both antimicrobial and antioxidant activities to heal, strike infection, and the inherent microbial resistance. Hereupon, chitosan (CS)-based microparticles (as CM) were designed and developed as carriers of tannic acid (TA). These CMTA were designed to improve TA stability, bioavailability, and delivery in situ. The CMTA were prepared by spray dryer technique and were characterized regarding encapsulation efficiency, kinetic release, and morphology. Antimicrobial potential was evaluated against methicillin-resistant and methicillin-sensitive Staphylococcus aureus (MRSA and MSSA), Staphylococcus epidermidis, Escherichia coli, Candida albicans, and Pseudomonas aeruginosa strains, as common wound pathogens, and the agar diffusion inhibition growth zones were tested for antimicrobial profile. Biocompatibility tests were performed using human dermal fibroblasts. CMTA had a satisfactory product yield of ca. 32% and high encapsulation efficiency of ca. 99%. Diameters were lower than 10 µm, and the particles showed a spherical morphology. The developed microsystems were also antimicrobial for representative Gram+, Gram-, and yeast as common wound contaminants. CMTA improved cell viability (ca. 73%) and proliferation (ca. 70%) compared to free TA in solution and even compared to the physical mixture of CS and TA in dermal fibroblasts.

Karitane Parenting Confidence Scale: measuring parenting self-efficacy in Portuguese mothers during the first year postpartum.

BACKGROUND: The Karitane Parenting Confidence Scale (KPCS) was designed to assess parenting self-efficacy in parents of infants during the first year. OBJECTIVE: The aim of this study was to analyse the psychometric characteristics of the KPCS in Portuguese mothers during the first-year postpartum. METHODS: A sample of 383 mothers were recruited at two public outpatient units in Northern Portugal. Mothers completed the KPCS, a sociodemographic questionnaire, and measures of depressive and anxiety symptoms at least one time between two weeks, three, six and 12 months postpartum. RESULTS: Good fit was found for a factor model with three subscales: parenting, support and child development. The KPCS presented good internal consistency. Regarding the criterion validity of the KPCS, significant effects of mother's age were found on the development subscale and significant associations were found between mother's depressive and anxiety symptoms and the KPCS total scale and subscales. Optimal clinical cut-offs were suggested. CONCLUSION: Findings provided evidence on the psychometric characteristics of the KPCS which can be used to assess parenting self-efficacy in Portuguese mothers during the first-year postpartum, possibly identifying mothers with low parenting self-efficacy.

Two Immersive Virtual Reality Tasks for the Assessment of Spatial Orientation in Older Adults with and Without Cognitive Impairment: Concurrent Validity, Group Comparison, and Accuracy Results.

OBJECTIVE: Spatial disorientation is common in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI), and preclinical individuals with AD biomarkers. However, traditional neuropsychological tests lack ecological validity for the assessment of spatial orientation and to date, there is still no gold standard. The current study aimed to determine the validity and accuracy of two virtual reality tasks for the assessment of spatial orientation. METHODS: We adapted two spatial orientation tasks to immersive virtual environments: a "survey to route" task in which participants had to transfer information from a map to their body position within a maze [Spatial Orientation in Immersive Virtual Environment Test (SOIVET) Maze], and an allocentric-type, route learning task, with well-established topographic landmarks (SOIVET Route). A total of 19 MCI patients and 29 cognitively healthy older adults aged 61-92 participated in this study. Regular neuropsychological assessments were used for correlation analysis and participant performances were compared between groups. Receiver Operating Characteristic (ROC) curve analysis was performed for accuracy. RESULTS: The SOIVET Maze correlated with measures of visuoperception, mental rotation, and planning, and was not related to age, educational level, or technology use profile. The SOIVET Route immediate correlated with measures of mental rotation, memory, and visuoconstruction, and was influenced only by education. Both tasks significantly differentiated MCI and control groups, and demonstrated moderate accuracy for the MCI diagnosis. CONCLUSION: Traditional neuropsychological assessment presents limitations and immersive environments allow for the reproduction of complex cognitive processes. The two immersive virtual reality tasks are valid tools for the assessment of spatial orientation and should be considered for cognitive assessments of older adults.

Opicapone versus placebo in the treatment of Parkinson's disease patients with end-of-dose motor fluctuation-associated pain: rationale and design of the randomised, double-blind OCEAN (OpiCapone Effect on motor fluctuations and pAiN) trial.

BACKGROUND: Optimisation of dopaminergic therapy may alleviate fluctuation-related pain in Parkinson's disease (PD). Opicapone (OPC) is a third-generation, once-daily catechol-O-methyltransferase inhibitor shown to be generally well tolerated and efficacious in reducing OFF-time in two pivotal trials in patients with PD and end-of-dose motor fluctuations. The OpiCapone Effect on motor fluctuations and pAiN (OCEAN) trial aims to investigate the efficacy of OPC 50 mg in PD patients with end-of-dose motor fluctuations and associated pain, when administered as adjunctive therapy to existing treatment with levodopa/dopa decarboxylase inhibitor (DDCi). METHODS: OCEAN is a Phase IV, international, multicentre, randomised, double-blind, placebo-controlled, parallel-group, interventional trial in PD patients with end-of-dose motor fluctuations and associated pain. It consists of a 1-week screening period, 24-week double-blind treatment period and 2-week follow-up period. Eligible patients will be randomised 1:1 to OPC 50 mg or placebo once daily while continuing current treatment with levodopa/DDCi and other chronic, stable anti-PD and/or analgesic treatments. The primary efficacy endpoint is change from baseline in Domain 3 (fluctuation-related pain) of the King's Parkinson's disease Pain Scale (KPPS). The key secondary efficacy endpoint is change from baseline in Domain B (anxiety) of the Movement Disorder Society-sponsored Non-Motor rating Scale (MDS-NMS). Additional secondary efficacy assessments include other domains and total scores of the KPPS and MDS-NMS, the Parkinson's Disease Questionnaire (PDQ-8), the MDS-sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts III and IV, Clinical and Patient's Global Impressions of Change, and change in functional status via Hauser's diary. Safety assessments include the incidence of treatment-emergent adverse events. The study will be conducted in approximately 140 patients from 50 clinical sites in Germany, Italy, Portugal, Spain and the United Kingdom. Recruitment started in February 2021 and the last patient is expected to complete the study by late 2022. DISCUSSION: The OCEAN trial will help determine whether the use of adjunctive OPC 50 mg treatment can improve fluctuation-associated pain in PD patients with end-of-dose motor fluctuations. The robust design of OCEAN will address the current lack of reliable evidence for dopaminergic-based therapy in the treatment of PD-associated pain. TRIAL REGISTRATION: EudraCT number 2020-001175-32 ; registered on 2020-08-07.

Motor-related health care for 5-year-old children born extremely preterm with movement impairments.

AIM: To (1) determine the proportion of 5-year-old children born extremely preterm (EPT) with movement difficulties including cerebral palsy (CP) and the proportion of these children receiving motor-related health care (MRHC), and (2) describe factors associated with receiving MRHC. METHOD: Children born before 28 weeks' gestation in 2011 to 2012 in 11 European countries were assessed with the Movement Assessment Battery for Children, Second Edition (MABC-2) at 5 years of age. Information on family characteristics, child health including CP diagnosis, and health care use were collected using parent-report questionnaires. MRHC was defined as visits in the previous year with health care providers (physical and occupational therapists) specialized in assessing/treating motor problems. We analysed receipt of MRHC and associated factors among children at risk of movement difficulties (MABC-2 score 6th-15th centiles), with significant movement difficulties (SMD; ≤5th centile) or with CP. RESULTS: Of 807 children assessed at 5 years 7 months (SD 4 months; 4 years 7 months-7 years 1 month), 412 were males (51.1%), 170 (21.1%) were at risk of movement difficulties, 201 (24.9%) had SMD, and 92 (11.4%) had CP. Those who received MRHC comprised 89.1% of children with CP, 42.8% with SMD, and 25.9% at risk of movement difficulties. MRHC for children with SMD varied from 23.3% to 66.7% between countries. Children were more likely to receive MRHC if they had other developmental problems or socioemotional, conduct, or attention difficulties. INTERPRETATION: Efforts are needed to increase MRHC for 5-year-old children born EPT with movement difficulties. WHAT THIS PAPER ADDS: Children born extremely preterm without cerebral palsy frequently experienced motor difficulties. Most of these children were not receiving motor-related health care (MRHC). Large geographical differences throughout Europe were observed in receipt of MRHC. Socioemotional problems were related to MRHC use.

Feasibility and acceptability of psychosocial care for unsuccessful fertility treatment.

INTRODUCTION: Many people undergo fertility treatment to have biological children, but around four in ten patients complete all treatment cycles without having the children they desire. This triggers intense grief from which patients report taking on average 2 years to recover. Fertility guidelines and regulators stress the need to support patients through this process, but there is a scarcity of evaluated interventions to this end and evidence about when and how to offer care is lacking. This study explored patients' and healthcare professionals' (HCPs) experiences of and views about provision of psychosocial care (to patients facing unsuccessful fertility treatment, i.e., care provided by a mental health professional to address the emotional, cognitive, behavioural, relational and social needs that patients have at this stage of treatment). METHODS: Five qualitative online focus groups were conducted with Portuguese participants: three with patients waiting to initiate or undergoing their last cycle of in vitro fertilization/intracytoplasmic sperm injection or having completed it within the last 2 months without achieving a pregnancy and two with HCPs working at fertility clinics. Focus groups were recorded and transcribed verbatim, and data were analysed with Framework Analysis. RESULTS: Thirteen patients and nine HCPs participated. Analysis resulted in 1293 codes, systematically organized into 13 categories, 4 themes and 1 metatheme. The latter showed high consensus about the need for psychosocial care for unsuccessful treatment, but perceived challenges in its implementation. Themes reflected (1) consensual demand for psychosocial care at all stages of treatment but particularly at the end, (2) high perceived acceptability of integrating preventive care initiated during treatment with early psychosocial care only for those patients who experience unsuccessful treatment, (3) perceived challenges of implementing psychosocial care for unsuccessful treatment at clinics and (4) suggestions to promote its acceptability and feasibility. CONCLUSION: Patients and HCPs perceive that clinics should improve care provision across the whole treatment pathway and in particular for unsuccessful fertility treatment. Suggestions were made to inform future research focusing on the development and evaluation of psychosocial interventions to this end. PATIENT OR PUBLIC CONTRIBUTION: Patients and HCPs participated in the focus groups. Two HCPs also revised the manuscript.

Effect of Raw and Roasted Phoenix dactylifera L. Seed Polyphenols Extracts on Suppression of Angiogenesis in Endothelial Cells.

Date seed is a by-product of Phoenix dactylifera L. fruit which is well recognized for its polyphenols content and numerous health-beneficial effects. Due to the increasing interest in natural phytochemicals with antioxidant activities, the present study aimed to extract polyphenols from both raw and roasted date seeds and investigate the anti-angiogenic effect of these two extracts (raw and roasted date seed polyphenols extracts (DSPE) at 25 and 50 µg/mL) using human microvascular endothelial cells (HMVEC). Our results showed that both raw and roasted DSPE suppressed some angiogenesis features in a dose-dependent manner including cell proliferation, migration, and capillary-like structure formation, of which raw DSPE was more potent inhibitor than roasted DSPE. Reduction in reactive oxygen species, as well as enhancement of superoxide dismutase activity occurred using both raw and roasted date seed polyphenols extracts. However, no changes were observed in advanced oxidation protein products versus control. Taken together, our data indicated that raw and roasted DSPE possess antioxidant activity, which suggested their potential use as a source of polyphenols with anti-angiogenic properties. Nevertheless, further studies are required to explore the underlying mechanisms responsible for their anti-angiogenic activities.