bluuebunny/crossref_metadata_2025 huggingface dataset:
Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial
Authors: Forbes Nauzer , Elmunzer B. Joseph , Allain Thibault , Chau Millie , Koury Hannah F. , Bass Sydney , Belletrutti Paul J. , Cole Martin J. , Gonzalez-Moreno Emmanuel , Kayal Ahmed , Kumar Puja , Mohamed Rachid , Turbide Christian , Buret Andre G. , Heitman Steven J.
Published: March 2020

Background

Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes.

Methods

A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use.

Discussion

The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level.

Trial registration

This trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.
Use of microbiological and patient data for choice of empirical antibiotic therapy in acute cholangitis
Authors: Kruis Tassilo , Güse-Jaschuck Sarah , Siegmund Britta , Adam Thomas , Epple Hans-Jörg
Published: March 2020

Background

Ineffective antibiotic therapy increases mortality of acute cholangitis. The choice of antibiotics should reflect local resistance patterns and avoid the overuse of broad-spectrum agents. In this study, we analysed how results of bile and blood cultures and patient data can be used for selection of empirical antibiotic therapy in acute cholangits.

Methods

Pathogen frequencies and susceptibility rates were determined in 423 positive bile duct cultures and 197 corresponding blood cultures obtained from 348 consecutive patients with acute cholangitis. Patient data were retrieved from the medical records. Associations of patient and microbiological data were assessed using the Chi-2 test and multivariate binary logistic regression.

Results

In bile cultures, enterobacterales and enterococci were isolated with equal frequencies of approximately 30% whereas in blood cultures, enterobacterales predominated (56% compared to 21% enterococci). Antibiotic resistance rates of enterobacterales were > 20% for fluorochinolones, cephalosporines and acylureidopenicillins but not for carbapenems (< 2%). The efficacy of empirical therapy was poor with a coverage of bacterial bile and blood culture isolates in 51 and 69%, respectively. By multivariate analysis, predictors for pathogen species, antibiotic susceptibility and expected antibiotic coverage were identified.

Conclusions

In unselected patients treated for acute cholangitis in a large tertiary refferential center, use of carbapenems seems necessary to achieve a high antibiotic coverage. However, by analysis of patient and microbiological data, subgroups for highly effective carbapenem-sparing therapy can be defined. For patients with community-acquired cholangitis without biliary prosthesis who do not need intensive care, piperacillin/tazobactam represents a regimen with an expected excellent antibiotic coverage.
Direct endoscopic full-thickness resection for submucosal tumors with an intraluminal growth pattern originating from the muscularis propria layer in the gastric fundus
Authors: Hu Jinlong , Ge Nan , Wang Sheng , Guo Jintao , Liu Xiang , Wang Guoxin , Sun Siyu
Published: March 2020

Background and aims

Endoscopic full-thickness resection (EFTR) is difficult to perform in a retroflexed fashion in the gastric fundus. The present study aims at exploring whether direct EFTR can be a simple, effective and safe procedure to treat intraluminal-growth submucosal tumors originating from the muscularis propria.

Methods

The patients with intraluminal-growth submucosal tumors originating from the muscularis propria in gastric fundus treated by direct EFTR between 01 January 2017 and 01 September 2018 were retrospectively reviewed. In addition, we analyzed the patients with intraluminal-growth submucosal tumors originating from the muscularis propria in gastric fundus treated by traditional EFTR. The differences in tumor resection time, cost-effectiveness, and complication rate were evaluated.

Results

Forty patients were enrolled in the present study, 20 patients of which were in the direct EFTR group and 20 patients of which were in the traditional EFTR group. En-bloc resections of gastric tumors were successfully performed in all 40 cases. There was no significant difference in the average tumor size of the two groups (24.3 ± 2.9 mm in direct EFTR group verus 24.0 ± 2.6 mm in the traditional group, p = 0.731), but significant difference existed in the operative time between two groups (35.0 ± 8.2 min in direct EFTR group verus 130.6 ± 51.9 min in the traditional group, p<0.05). No complications, such as postoperative bleeding and perforation, occurred in any groups.

Conclusions

Direct EFTR is a safe, simple and cost-effective procedure for SMTs with an intraluminal growth pattern originating from the muscularis propria layer in the gastric fundus.
Prevalence and associated factors for frailty among elder patients in China: a multicentre cross-sectional study
Authors: Jiao Jing , Wang Yu , Zhu Chen , Li Fangfang , Zhu Minglei , Wen Xianxiu , Jin Jingfen , Wang Hui , Lv Dongmei , Zhao Shengxiu , Wu Xinjuan , Xu Tao
Published: March 2020

Background

To date, most previous studies of frailty among hospitalized elderly Chinese patients have been conducted based on small samples, which cannot represent the elderly patient population. The aim of this study was to identify the prevalence of and risk factors for frailty among elderly patients in China.

Study design and setting

This cross-sectional study surveyed 9996 elderly patients from 6 tertiary-level hospitals in China. The prevalence of frailty among patients from selected wards was surveyed by trained investigators. A mixed-effects Poisson regression model was used to analyse the factors associated with frailty among elderly patients.

Results

The mean age of all subjects was 72.47 ± 5.77 years. The prevalence rate of frailty in this study was 18.02%. After adjustments were made for the confounding effect of the clustering of hospital wards, a mixed-effects Poisson regression model showed that the associated factors of frailty included the following: age (OR: 1.016, 95% CI: 1.012–1.020), BMI < 18.5 (OR: 1.248, 95% CI: 1.171–1.330), female gender (OR: 1.058, 95% CI: 1.004–1.115), ethnic minority (OR: 1.152, 95% CI: 1.073–1.236), admission to hospital by the emergency department (OR: 1.104, 95% CI: 1.030–1.184), transit from another hospital (OR: 1.159, 95% CI: 1.049–1.279), former alcohol use (OR: 1.094, 95% CI: 1.022–1.171), fall history in the past 12 months (OR: 1.257, 95% CI: 1.194–1.323), vision dysfunction (OR: 1.144, 95% CI: 1.080–1.211), cognition impairment (OR: 1.182, 95% CI: 1.130–1.237), sleeping dysfunction (OR: 1.215, 95% CI: 1.215–1.318), urinary dysfunction (OR: 1.175, 95% CI: 1.104–1.251), and defecation dysfunction (OR: 1.286, 95% CI: 1.217–1.358). The results also showed some of the following protective effects: BMI > 28 (OR: 0.897, 95% CI: 0.856–0.940); higher education level, including middle school (OR: 0.915, 95% CI: 0.857, 0.977) and diploma and above (OR: 0.891, 95% CI: 0.821, 0.966); and current alcohol use (OR: 0.869, 95% CI: 0.815, 0.927).

Conclusion

We identified a relatively high prevalence of frailty among elderly patients, and there are several associated factors among the population derived from this investigation of a large-scale, multicentre, nationally representative Chinese elderly inpatient population.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1800017682, registered 09 August 2018.
The time series seasonal patterns of dengue fever and associated weather variables in Bangkok (2003-2017)
Authors: Polwiang Sittisede
Published: March 2020

Background

In Thailand, dengue fever is one of the most well-known public health problems. The objective of this study was to examine the epidemiology of dengue and determine the seasonal pattern of dengue and its associate to climate factors in Bangkok, Thailand, from 2003 to 2017.

Methods

The dengue cases in Bangkok were collected monthly during the study period. The time-series data were extracted into the trend, seasonal, and random components using the seasonal decomposition procedure based on loess. The Spearman correlation analysis and artificial neuron network (ANN) were used to determine the association between climate variables (humidity, temperature, and rainfall) and dengue cases in Bangkok.

Results

The seasonal-decomposition procedure showed that the seasonal component was weaker than the trend component for dengue cases during the study period. The Spearman correlation analysis showed that rainfall and humidity played a role in dengue transmission with correlation efficiency equal to 0.396 and 0.388, respectively. ANN showed that precipitation was the most crucial factor. The time series multivariate Poisson regression model revealed that increasing 1% of rainfall corresponded to an increase of 3.3% in the dengue cases in Bangkok. There were three models employed to forecast the dengue case, multivariate Poisson regression, ANN, and ARIMA. Each model displayed different accuracy, and multivariate Poisson regression was the most accurate approach in this study.

Conclusion

This work demonstrates the significance of weather in dengue transmission in Bangkok and compares the accuracy of the different mathematical approaches to predict the dengue case. A single model may insufficient to forecast precisely a dengue outbreak, and climate factor may not only indicator of dengue transmissibility.
Cobalamin c deficiency associated with antifactor h antibody-associated hemolytic uremic syndrome in a young adult
Authors: Philipponnet C. , Desenclos J. , Brailova M. , Aniort J. , Kemeny J. L. , Deville C. , Fremeaux-Bacchi V. , Souweine B. , Heng A. E.
Published: March 2020

Background

Thrombotic microangiopathy (TMA) syndromes are characterized by the association of hemolytic anemia, thrombocytopenia and organ injury due to arteriolar and capillary thrombosis.

Case presentation

We report the first case of adult onset cobalamin C (Cbl C) disease associated with anti-factor H antibody-associated hemolytic uremic syndrome (HUS).

A 19-year-old woman was admitted to the nephrology department owing to acute kidney failure, proteinuria, and hemolytic anemia with schizocytes.

TMA was diagnosed and plasma exchanges were started in emergency.

Exhaustive analyses showed 1) circulating anti factor H antibody and 2) hyperhomocysteinemia, hypomethioninemia and high levels of methylmalonic aciduria pointing towards Clb C disease. Cbl C disease has been confirmed by methylmalonic aciduria and homocystinuria type C protein gene sequencing revealing two heterozygous pathogenic variants.

The kidney biopsy showed 1) intraglomerular and intravascular thrombi 2) noticeable thickening of the capillary wall with a duplication aspect of the glomerular basement membrane and a glomerular capillary wall IgM associated with Cbl C disease related TMA.

We initiated treatment including hydroxycobalamin, folinic acid, betaine and levocarnitine and Eculizumab. Rituximab infusions were performed allowing a high decrease in anti-factor H antibody rate.

Six month after the disease onset, Eculizumab was weaning and vitaminotherapy continued. Outcome was favorable with a dramatic improvement in kidney function.

Conclusion

TMA with renal involvement can have a complex combination of risk factors including anti-FH autoantibody in the presence of cblC deficiency.
Symptomatic hemiparkinsonism due to extensive middle and posterior fossa arachnoid cyst: case report
Authors: Wimmer Bernadette , Mangesius Stephanie , Seppi Klaus , Iglseder Sarah , Di Pauli Franziska , Ortler Martin , Gizewski Elke , Poewe Werner , Wenning Gregor Karl
Published: March 2020

Introduction

Intracranial neoplasms are an uncommon cause of symptomatic parkinsonism. We here report a patient with an extensive middle and posterior fossa arachnoid cyst presenting with parkinsonism that was treated by neurosurgical intervention.

Methods

Retrospective chart review and clinical examination of the patient.

Case report

This 55-year-old male patient with hemiparkinsonism and recurrent bouts of headaches was first diagnosed in 1988. CT scans revealed multiple cystic lesions compressing brainstem and basal ganglia, which were partially resected. Subsequently, the patient was free of complaints for 20 years. In 2009 the patient presented once more with severe unilateral tremor and thalamic pain affecting the right arm. Despite symptomatic treatment with L-Dopa and pramipexole symptoms worsened over time. In 2014 there was further progression with increasing hemiparkinsonism, hemidystonia, unilateral thalamic pain and pyramidal signs. Repeat CT scanning revealed a progression of the cysts as well as secondary hydrocephalus. Following repeat decompression of the brainstem and fenestration of all cystic membranes parkinsonism improved with a MDS- UPDRS III score reduction from 39 to 21. Histology revealed arachnoid cystic material.

Conclusion

We report on a rare case of recurrent symptomatic hemiparkinsonism resulting from arachnoid cysts.
Intergenerational transmission of health disparities among Turkish-origin immigrants in Germany: study protocol of a multi-centric cohort study (BaBi-stress and BaBeK study)
Authors: Spallek Jacob , Scholaske Laura , Kurt Medlin , Lindner-Matthes Denise , Entringer Sonja
Published: March 2020

Background

Immigrants in Germany exhibit higher levels of social disadvantage when compared to the non-immigrated population. Turkish-origin immigrants constitute an important immigrant group in Germany and show disparities in some health domains that are evident from birth onwards. Several studies have shown the mechanisms by which social disadvantage is biologically embedded to affect health over the lifespan. Relatively little, however, is still known about if and how the maternal social situation is transmitted to the next generation. This study therefore aims to analyse the effects of maternal socioeconomic status and migration status on stress-related maternal-placental-fetal (MPF) biological processes during pregnancy on infant birth and health outcomes.

Methods

This longitudinal cohort study of N = 144 child-mother dyads is located at two study sites in Germany and includes pregnant women of Turkish origin living in Germany as well as pregnant German women. During pregnancy, MPF stress biology markers from maternal blood and saliva samples, maternal socio-economic and migration-related information, medical risk variables and psychological well-being are assessed. After birth, infant anthropometric measures and developmental outcomes are assessed. The same measures will be assessed in and compared to Turkish pregnant women based on a collaboration with BABIP study in Istanbul.

Discussion

This is the first study on intergenerational transmission of health disparities in Germany with a focus on women of Turkish-origin. The study faces similar risks of bias as other birth cohorts do. The study has implemented various measures, e.g. culturally sensitive recruitment strategies, attempt to recruit and follow-up as many pregnant women as possible independent of their social or cultural background. Nevertheless, the response rate among lower-educated families is lower. The possibility to compare results with a cohort from Turkey is a strength of this study. However, starting at different times and with slightly different recruitment strategies and designs may result in cohort effects and may affect comparability of the sub-cohorts.

Trial registration

N.A. (Observational study, no clinical trial, no interventions on human participants).
Herbal medicine use and predictors among pregnant women attending antenatal care in Ethiopia: a systematic review and meta-analysis
Authors: Adane Fentahun , Seyoum Girma , Alamneh Yoseph Merkeb , Abie Worku , Desta Melaku , Sisay Bihonegn
Published: March 2020

Background

The use of herbal medicine among pregnant women is increasing in many low- and high-income countries due to their cost-effectiveness in treatment and ease of access. Research findings across Ethiopia on the prevalence and predictors of herbal medicine use among pregnant women attending antenatal care are highly variable and inconsistent. Therefore, this systematic review and meta-analysis aims to estimate the overall prevalence of the use of herbal medicine and its predictors among pregnant women attending antenatal care in Ethiopia.

Method

We searched articles in Medline (PubMed), EMBASE, HINARI, Google Scholar, Science Direct, Cochrane Library, and other sources. The study included a total of eight studies that reported the prevalence and predictors of herbal medicine use among pregnant women from different regions of Ethiopia. Cochrane Q test statistics and I2 tests were used to assess heterogeneity. A random effect meta-analysis model was used to estimate the pooled prevalence. In addition, the association between risk factors and herbal medicine use in pregnant women attending antenatal care were examined.

Results

A total of eight studies were included in this review. The pooled prevalence of herbal medicine use among pregnant women attending antenatal care in Ethiopia was 47.77% (95% CI: 28.00–67.55). Subgroup analysis by geographic regions has showed that the highest prevalence (57.49%;95% CI: 53.14, 61.85) was observed in Oromia Region and the lowest prevalence was observed in Addis Ababa (31.39%; 95% CI: 2.83, 79.96). The herbal medicines commonly consumed by women during pregnancy were ginger: 41.11% (95% CI: 25.90, 56.32), damakasse: 34.63% (95% CI: 17.68, 51.58), garlic: 32.98% (95% CI: 22.21, 43.76), tenaadam: 19.59% (95% CI: 7.54, 31.63) and eucalyptus: 4.71% (95% CI: 1.1, 8.26). Mothers’ previous history of self-medication (95% CI: 1.91, 51.35), illness during pregnancy (95% CI: 1.56, 23.91), employment status (95% CI: 3.89, 10.89), educational status (95% CI: 1.52, 2.68), and place of residence (95% CI: 1.86, 3.23) were predictors of herbal medicine use by women during pregnancy.

Conclusion

In this study, about half of women attending antenatal care use herbal medicine and it is relatively high. The most commonly consumed herbal medicine during pregnancy was ginger followed by damakasse, garlic, tenaadam and eucalyptus. During pregnancy, it is not known that these most commonly consumed plant species have harmful fetal effects. However, many of the medicinal plant species are poorly studied, and it is not possible to rule out teratogenic effects. Teamwork between healthcare professionals and traditional practitioners to educate on the use of medicinal plants will encourage healthier pregnancies and better health for mothers and infants.
Mutation landscape of germline and somatic BRCA1/2 in patients with high-grade serous ovarian cancer
Authors: Eoh Kyung Jin , Kim Hye Min , Lee Jung-Yun , Kim Sunghoon , Kim Sang Wun , Kim Young Tae , Nam Eun Ji
Published: March 2020

Background

Poly (ADP-ribose) polymerase inhibitors targeting BRCA1/2 mutations are available for treating patients with high-grade serous ovarian cancer. These treatments may be more appropriately directed to patients who might respond if the tumor tissue is additionally tested by next-generation sequencing with a multi-gene panel and Sanger sequencing of a blood sample. In this study, we compared the results obtained using the next-generation sequencing multi-gene panel to a known germline BRCA1/2 mutational state determined by conventional Sanger sequencing to evaluate the landscape of somatic mutations in high-grade serous ovarian cancer tumors.

Methods

Cancer tissue from 98 patients with high-grade serous ovarian cancer who underwent Sanger sequencing for germline BRCA1/2 analysis were consecutively analyzed for somatic mutations using a next-generation sequencing 170-gene panel.

Results

Twenty-four patients (24.5%) showed overall BRCA1/2 mutations. Seven patients (7.1%) contained only somatic BRCA1/2 mutations with wild-type germline BRCA1/2, indicating acquired mutation of BRCA1/2. Three patients (3.1%) showed reversion of germline BRCA1 mutations. Among the 14 patients (14.3%) with both germline and somatic mutations in BRCA1/2, two patients showed different variations of BRCA1/2 mutations. The next-generation sequencing panel test for somatic mutation detected other pathogenic variations including RAD51D and ARID1A, which are possible targets of poly (ADP-ribose) polymerase inhibitors. Compared to conventional Sanger sequencing alone, next-generation sequencing-based tissue analysis increased the number of candidates for poly (ADP-ribose) polymerase inhibitor treatment from 17.3% (17/98) to 26.5% (26/98).

Conclusions

Somatic mutation analysis by next-generation sequencing, in addition to germline BRCA1/2 mutation analysis, should become the standard of care for managing women with high-grade serous ovarian cancer to widen the indication of poly (ADP-ribose) polymerase inhibitors.
High tumor budding is a strong predictor of poor prognosis in the resected perihilar cholangiocarcinoma patients regardless of neoadjuvant therapy, showing survival similar to those without resection
Authors: Ito Takahiro , Kuriyama Naohisa , Kozuka Yuji , Komatsubara Haruna , Ichikawa Ken , Noguchi Daisuke , Hayasaki Aoi , Fujii Tekehiro , Iizawa Yusuke , Kato Hiroyuki , Tanemura Akihiro , Murata Yasuhiro , Kishiwada Masashi , Mizuno Shugo , Usui Masanobu , Sakurai Hiroyuki , Isaji Shuji
Published: March 2020

Background

Tumor budding (TB) is used as an indicator of poor prognosis in various cancers. However, studies on TB in perihilar cholangiocarcinoma are still limited. We examined the significance of TB in resected perihilar cholangiocarcinoma with or without neoadjuvant therapy.

Methods

Seventy-eight patients who underwent surgical resection at our institution for perihilar cholangiocarcinoma from 2004 to 2017, (36 with neoadjuvant therapy), were enrolled in this study. TB was defined as an isolated cancer cell or clusters (< 5 cells) at the invasive front and the number of TB was counted using a 20 times objective lens. Patients were classified into two groups according to TB counts: low TB (TB < 5) and high TB (TB ≥5).

Results

In this 78 patient cohort, high TB was significantly associated with advanced tumor status (pT4: 50.0% vs 22.2%, p = 0.007, pN1/2: 70.8% vs 39.6%, p = 0.011, M1: 20.8% vs 1.9%) and higher histological grade (G3: 25.0% vs 5.7%, p = 0.014). Disease specific survival (DSS) in high TB was significantly inferior compared to that in low TB group (3-y DSS 14.5% vs 67.7%, p < 0.001). Interestingly, DSS in high TB showed similar to survival in unresected patients. In addition, high TB was also associated with advanced tumor status and poor prognosis in patients with neoadjuvant therapy. Multivariate analysis identified high TB as an independent poor prognostic factors for DSS (HR: 5.206, p = 0.001).

Conclusion

This study demonstrated that high TB was strongly associated with advanced tumor status and poor prognosis in resected perihilar cholangiocarcinoma patients. High TB can be a novel poor prognostic factor in resected perihilar cholangiocarcinoma regardless of neoadjuvant therapy.
Hemiplegic (unilateral) cerebral palsy in northern Stockholm: clinical assessment, brain imaging, EEG, epilepsy and aetiologic background factors
Authors: Tillberg Elsa , Isberg Bengt , Persson Jonas K. E.
Published: March 2020

Background

The purpose of this study was to describe clinical presentation, epilepsy, EEG, extent and site of the underlying cerebral lesion with special reference towards aetiologic background factors in a population-based group of children with hemiplegic cerebral palsy.

Methods

Forty-seven children of school- age, fulfilling the SPCE (Surveillance of Cerebral palsy in Europe)-criteria of hemiplegic cerebral palsy, identified via the Swedish cerebral palsy register, were invited and asked to participate in the study.

Results

Fifteen boys and six girls participated. Of the sixteen children born at term, five had no risk factors for cerebral palsy. Two out of five preterm children presented additional risk factors. Debut of motor impairment was observed in the first year of life in sixteen children. Age at diagnosis varied from 2 months to 6 years. Epilepsy was common and associated with grey- and white matter injury.

Conclusions

Recognizing the importance of risk factors for cerebral palsy, any child with these risk factors should be offered a check-up by a paediatrician or a paediatric neurologist. Thereby reducing diagnostic delay. Epilepsy is common in hemiplegic cerebral palsy and associated with grey- and white matter injury in this cohort.
Pharmacotherapy of restricted/repetitive behavior in autism spectrum disorder:a systematic review and meta-analysis
Authors: Yu Yanjie , Chaulagain Ashmita , Pedersen Sindre Andre , Lydersen Stian , Leventhal Bennett L. , Szatmari Peter , Aleksic Branko , Ozaki Norio , Skokauskas Norbert
Published: March 2020

Background

This paper is a systematic review and meta-analysis of the efficacy of available medications for the treatment of restricted/repetitive behavior (RRBs) in Autism Spectrum Disorder (ASD).

Method

We searched MEDLINE, Embase, PsycINFO, The Cochrane Library (Cochrane Database of Systematic Reviews (CDRS), the Cochrane Central Register of Controlled Trials (CENTRAL), database of Abstracts of Reviews of Effects (DARE)), Scopus, Epistimonikos, Clinicaltrials.gov, and included all randomized controlled trials published after 1993 that were directed at RRBs in patients with ASD of all ages. We extracted the relevant data from the published studies with a predefined data extraction form and assessed the risk of bias. The primary outcomes were change in restricted/repetitive behavior. We performed a meta-analysis using the random effect model and included studies with given mean and standard deviation. This study is registered with PROSPERO number CRD42018092660).

Results

We identified 14 randomized controlled trials that met initial inclusion criteria. After closer inspection, nine trials – involving 552 patients in total – were included in the final analysis. The meta-analysis found no significant difference between medications (including fluvoxamine, risperidone, fluoxetine, citalopram, oxytocin, N-Acetylcysteine, buspirone) and placebo in the treatment of RRBs in ASD (P = 0.20). Similarly, the sub-group meta-analysis also showed no significant difference between Selective Serotonin Reuptake Inhibitor (SSRIs) and placebo in the treatment of RRBs in ASD (P = 0.68). There was no evidence of publication bias.

Conclusion

This meta-analysis finds little support for the routine use of medications to treat restricted/repetitive behaviors in Autism Spectrum Disorder. Further research of large, balanced trials with precise assessment tools and long-term follow-up are needed.

Trial registration

The study protocol is registered in PROSPERO (Reference number: CRD42018092660).
Effectiveness of the female condom in preventing HIV and sexually transmitted infections: a systematic review and meta-analysis
Authors: Wiyeh Alison B. , Mome Ruth K. B. , Mahasha Phetole W. , Kongnyuy Eugene J. , Wiysonge Charles S.
Published: March 2020

Background

The effectiveness of female condoms for preventing HIV and sexually transmitted infections (STIs) remains inconclusive. We examined the effects of female condoms on the acquisition of HIV and STIs.

Methods

We searched four databases, two trial registries, and reference lists of relevant publications in October 2018 and updated our search in February 2020. We screened search output, evaluated study eligibility, and extracted data in duplicate; resolving differences through discussion. We calculated the effective sample size of cluster randomised trials using an intra-cluster correlation coefficient of 0·03. Data from similar studies were combined in a meta-analysis. We performed a non-inferiority analysis of new condoms relative to marketed ones using a non-inferiority margin of 3%. We assessed the certainty of evidence using GRADE.

Results

We included fifteen studies of 6921 women. We found that polyurethane female condoms (FC1) plus male condoms may be as effective as male condoms only in reducing HIV acquisition (1 trial, n = 149 women, RR 0.07, 95%CI 0.00–1.38; low-certainty evidence). However, the use of FC1 plus male condoms is superior to male condoms alone in reducing the acquisition of gonorrhoea (2 trials, n = 790, RR 0.59, 95%CI 0.41–0.86; high-certainty evidence) and chlamydia (2 trials, n = 790, RR 0.67, 95%CI 0.47–0.94; high-certainty evidence). Adverse events and failure rates of FC1 were very low and decreased during follow up. Although the functionality of newer female condoms (Woman’s, Cupid, Pheonurse, Velvet, and Reddy) may be non-inferior to FC2, there were no available studies assessing their efficacy in preventing HIV and STIs.

Conclusion

The use of female plus male condoms is more effective than use of male condoms only in preventing STIs and may be as effective as the male condom only in preventing HIV. There is a need for well conducted studies assessing the effects of newer female condoms on HIV and STIs.

PROSPERO registration number

CRD42018090710
A case report: white cord syndrome following anterior cervical discectomy and fusion: importance of prompt diagnosis and treatment
Authors: Jun Deuk Soo , Baik Jong-Min , Lee Seung-Kwan
Published: March 2020

Background

Objective: White cord syndrome is extremely rare and search of the literature has revealed very few cases. Postoperative MR scan revealed hyperintense intrinsic cord signal changes within cord ischemia and edema. It is thought to be caused by reperfusion injury of the spinal cord. This is called white cord syndrome. This report is very rare case of ‘White Cord Syndrome’ with paraplegia after anterior cervical discectomy and fusion (ACDF).

Case presentation

A 49-year-old woman presented with neck pain lasting for several months and second and third finger radiating pain. Severe cervical herniated intervertebral disc findings could be identified at C6–7 level on C-spine MRI. ACDF C6–7 surgery was performed. Immediately after the operation, physical examination revealed paraplegia and emergency MRI was performed. On MR images, T2 high signal myelopathy suspected as reperfusion injury at C6–7 level, and emergency surgery was performed under diagnosis of white cord syndrome. After the emergency operation, the paraplegic problem was gradually resolved. Before discharge, motor power and sensory deficit of bilateral lower extremity were fully recovered.

Conclusion

Surgeons should explain the possibility of white cord syndrome before cervical decompression surgery and should perform a neurological examination immediately after surgery. We recommend that the importance of early recognition and prompt treatment of white cord syndrome.
Bizarre parosteal osteochondromatous proliferation co-occurring with a metatarsal fatigue fracture: a case report
Authors: Yao Ruoyu , Goh En Lin , Fan Zhaoxiang , Wu Xuequn , Feng Yanqi
Published: March 2020

Background

Bizarre parosteal osteochondromatous proliferation (BPOP) is a relatively rare benign extraperiosteal osteochondroma-like proliferative lesion that shares similarities with malignant tumours in terms of morphology. The aetiology of BPOP has yet to be determined and there are no previous reports of BPOP associated with fracture.

Case presentation

A 57-year-old woman presented with a one-month history of pain and swelling in her right foot, which were worsened by activity and improved with rest. Physical examination revealed a hard, non-mobile mass measuring 1.5 cm × 1.5 cm on the dorsal aspect of the third metatarsal of the right foot. There was overlying erythema and tenderness on palpation. Computed tomography (CT) of the right foot demonstrated a fracture of the neck of the third metatarsal, osteolysis at the fracture site and soft tissue swelling. Bone scintigraphy revealed increased tracer uptake suggesting abnormal bone metabolism at the neck of the third metatarsal. Surgical excision of the lesion was performed. Histopathology and immunohistochemistry confirmed the diagnosis of BPOP.

Conclusion

BPOP is a rare benign lesion that is commonly misdiagnosed. Differential diagnosis is mainly achieved through imaging and histopathological assessment.
Free vitamin D correlate better with bone mineral density and thoracolumbar junction osteoporotic vertebral fractures than serum vitamin D
Authors: chhantyal Kishor , He Lei , Mo Jian , Yin Mingyu , He Tianwei , Chen Yuyong , Yang Yang , Zhang Liangming , Rong Limin
Published: March 2020

Background

Vitamin D deficiency has long been studied as a risk factor for osteoporosis. However, the association between serum vitamin D status, bone mineral density (BMD) and the incidence of vertebral fractures (OVFs) remain controversial. It is believed that free portion of the circulating vitamin D carries the metabolic activities of vitamin D. Therefore, the aim of the present study is to analyse if free vitamin D correlates with BMD and osteoporotic fragile vertebral fractures in the elderly population.

Methods

A total of 90 consecutive patients, including 81 female and 9 male patients, aged > 48 years, were included in this cross sectional study between March and July of 2018. Total vitamin D (total 25(OH)D), free vitamin D (free 25(OH)D), calcium and phosphorus were measured. BMD was measured using dual energy X-ray absorptiometry (DEXA) and osteoporotic vertebral fracture was assessed using plain radiograph. Multiple linear regression was performed to find out the association between total vitamin D, free vitamin D and BMD at various sites. To evaluate the association with osteoporotic vertebral multivariate logistic regression model was used.

Results

The mean total vitamin D and free vitamin D were 25.1 ± 10.2 and 6.1 ± 1.7 respectively. Free vitamin D had a linear correlation with total vitamin D (R2 = 0.69). While free vitamin D had a positive correlation with lumbar BMD roles (p < 0.05), total vitamin D didn’t have any association with BMD at any site. Of the total patients, 62 patients (68.9%) had thoracolumbar junction OVFs. Free vitamin D level correlated with the prevalence of OVFs as well as lumbar osteoporosis (p < 0.05). However, there was no statistical correlation between serum vitamin D status and the OVFs.

Conclusions

Free vitamin D was significantly related to the occurrence of thoracolumbar junction OVFs and lumbar BMD, which assumed to be a positive predictor for fracture and osteoporosis prevention. However, total serum vitamin D levels did not have any association with BMD at different sites as well as fragile vertebral fracture.

Trial registration

The study is registered at clinicaltrials.gov NCT03605173.
Methodology of the health economic evaluation of the Feel4Diabetes-study
Authors:   on behalf of the Feel4Diabetes research group, Willems Ruben , Pil Lore , Lambrinou Christina-Paulina , Kivelä Jemina , Wikström Katja , Gonzalez-Gil Esther M. , De Miguel-Etayo Pilar , Nánási Anna , Semánová Csilla , Van Stappen Vicky , Cardon Greet , Tsochev Kaloyan , Iotova Violeta , Chakarova Nevena , Makrilakis Konstantinos , Dafoulas George , Timpel Patrick , Schwarz Peter , Manios Yannis , Annemans Lieven
Published: March 2020

Background

The clinical and economic burden of type 2 diabetes mellitus on society is rising. Effective and efficient preventive measures may stop the increasing prevalence, given that type 2 diabetes mellitus is mainly a lifestyle-driven disease. The Feel4Diabetes-study aimed to tackle unhealthy lifestyle (unhealthy diet, lack of physical activity, sedentary behaviour, and excess weight) of families with a child in the first grades of elementary school. These schools were located in regions with a relatively low socio-economic status in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. Special attention was paid to families with a high risk of developing type 2 diabetes mellitus.

Methods

The aim of this paper is to describe the detailed methodology of the intervention’s cost-effectiveness analysis. Based on the health economic evaluation of the Toybox-study, both a decision analytic part and a Markov model have been designed to assess the long-term (time horizon of 70 year with one-year cycles) intervention’s value for money. Data sources used for the calculation of health state incidences, transition probabilities between health states, health state costs, and health state utilities are listed. Intervention-related costs were collected by questionnaires and diaries, and attributed to either all families or high risk families only.

Conclusions

The optimal use of limited resources is pivotal. The future results of the health economic evaluation of the Feel4Diabetes-study will contribute to the efficient use of those resources.
When a child dies: a systematic review of well-defined parent-focused bereavement interventions and their alignment with grief- and loss theories
Authors: Kochen Eline M. , Jenken Floor , Boelen Paul A. , Deben Laura M. A. , Fahner Jurrianne C. , van den Hoogen Agnes , Teunissen Saskia C. C. M. , Geleijns Karin , Kars Marijke C.
Published: March 2020

Background

The availability of interventions for bereaved parents have increased. However, most are practice based. To enhance the implementation of bereavement care for parents, an overview of interventions which are replicable and evidence-based are needed. The aim of this review is to provide an overview of well-defined bereavement interventions, focused on the parents, and delivered by regular health care professionals. Also, we explore the alignment between the interventions identified and the concepts contained in theories on grief in order to determine their theoretical evidence base.

Method

A systematic review was conducted using the methods PALETTE and PRISMA. The search was conducted in MEDLINE, Embase, and CINAHL. We included articles containing well-defined, replicable, paediatric bereavement interventions, focused on the parent, and performed by regular health care professionals. We excluded interventions on pathological grief, or interventions performed by healthcare professionals specialised in bereavement care. Quality appraisal was evaluated using the risk of bias, adapted risk of bias, or COREQ. In order to facilitate the evaluation of any theoretical foundation, a synthesis of ten theories about grief and loss was developed showing five key concepts: anticipatory grief, working models or plans, appraisal processes, coping, and continuing bonds.

Results

Twenty-one articles were included, describing fifteen interventions. Five overarching components of intervention were identified covering the content of all interventions. These were: the acknowledgement of parenthood and the child’s life; establishing keepsakes; follow-up contact; education and information, and; remembrance activities. The studies reported mainly on how to conduct, and experiences with, the interventions, but not on their effectiveness. Since most interventions lacked empirical evidence, they were evaluated against the key theoretical concepts which showed that all the components of intervention had a theoretical base.

Conclusions

In the absence of empirical evidence supporting the effectiveness of most interventions, their alignment with theoretical components shows support for most interventions on a conceptual level. Parents should be presented with a range of interventions, covered by a variety of theoretical components, and aimed at supporting different needs. Bereavement interventions should focus more on the continuous process of the transition parents experience in readjusting to a new reality.

Trial registration

This systematic review was registered in Prospero (registration number:CRD42019119241).
First referral to an integrated onco-palliative care program: a retrospective analysis of its timing
Authors: Barth Claire , Colombet Isabelle , Montheil Vincent , Huillard Olivier , Boudou-Rouquette Pascaline , Tlemsani Camille , Alexandre Jérôme , Goldwasser François , Vinant Pascale
Published: March 2020

Background

Palliative care (PC) referral is recommended early in the course of advanced cancer. This study aims to describe, in an integrated onco-palliative care program (IOPC), patient’s profile when first referred to this program, timing of this referral and its impact on the trajectory of care at end-of-life.

Methods

The IOPC combined the weekly onco-palliative meeting (OPM) dedicated to patients with incurable cancer, and/or the clinical evaluation by the PC team. Oncologists can refer to the multidisciplinary board of the OPM the patients for whom goals and organization of care need to be discussed. We analyzed all patients first referred at OPM in 2011–2013. We defined the index of precocity (IP), as the ratio of the time from first referral to death by the time from diagnosis of incurability to death, ranging from 0 (late referral) to 1 (early referral).

Results

Of the 416 patients included, 57% presented with lung, urothelial cancers, or sarcoma. At first referral to IOPC, 76% were receiving antitumoral treatment, 63% were outpatients, 56% had a performance status ≤2 and 46% had a serum albumin level > 35 g/l. The median [1st-3rd quartile] IP was 0.39 [0.16–0.72], ranging between 0.53 [0.20–0.79] (earliest referral, i.e. close to diagnosis of incurability, for lung cancer) to 0.16 [0.07–0.56] (latest referral, i.e. close to death relatively to length of metastatic disease, for prostate cancer). Among 367 decedents, 42 (13%) received antitumoral treatment within 14 days before death, and 157 (43%) died in PC units.

Conclusions

The IOPC is an effective organization to enable early integration of PC and decrease aggressiveness of care near the end-of life. The IP is a useful tool to model the timing of referral to IOPC, while taking into account each cancer types and therapeutic advances.
Induction of peroxisome proliferator activated receptor γ (PPARγ) mediated gene expression and inhibition of induced nitric oxide production by Maerua subcordata (Gilg) DeWolf
Authors: Hiben Mebrahtom Gebrelibanos , de Haan Laura , Spenkelink Bert , Wesseling Sebastiaan , Vervoort Jacques , Rietjens Ivonne M. C. M.
Published: March 2020

Background

The health benefits of botanicals is linked to their phytochemicals that often exert pleiotropic effects via targeting multiple molecular signaling pathways such as the peroxisome proliferator-activated receptors (PPARs) and the nuclear factor kappaB (NFκB). The PPARs are transcription factors that control metabolic homeostasis and inflammation while the NF-κB is a master regulator of inflammatory genes such as the inducible nitric-oxide synthase that result in nitric oxide (NO) overproduction.

Methods

Extracts of Maerua subcordata (MS) and selected candidate constituents thereof, identified by liquid chromatography coupled to mass spectroscopy, were tested for their ability to induce PPARγ mediated gene expression in U2OS-PPARγ cells using luciferase reporter gene assay and also for their ability to inhibit lipopolysaccharide (LPS) induced NO production in RAW264.7 macrophages. While measuring the effect of test samples on PPARγ mediated gene expression, a counter assay that used U2OS-Cytotox cells was performed to monitor cytotoxicity or any non-specific changes in luciferase activity.

Results

The results revealed that the fruit, root, and seed extracts were non-cytotoxic up to a concentration of 30 g dry weight per litre (gDW/L) and induced PPARγ mediated gene expression but the leaf extract showed some cytotoxicity and exhibited minimal induction. Instead, all extracts showed concentration (1–15 gDW/L) dependent inhibition of LPS induced NO production. The root extract showed weaker inhibition. Among the candidate constituents, agmatine, stachydrine, trigonelline, indole-3-carboxyaldehyde, plus ethyl-, isobutyl-, isopropyl, and methyl-isothiocyanates showed similar inhibition, and most showed increased inhibition with increasing concentration (1–100 μM) although to a lesser potency than the positive control, aminoguanidine.

Conclusion

The present study demonstrated for the first time the induction of PPARγ mediated gene expression by MS fruit, root, and seed extracts and the inhibition of LPS induced NO production by MS fruit, leaf, root, and seed extracts and some candidate constituents thereof.