bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluating the safety, effectiveness and acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial
Authors: Atuhairwe Susan , Byamugisha Josaphat , Allvin Marie Klingberg , Cleeve Amanda , Hanson Claudia , Tumwesigye Nazarius Mbona , Kakaire Othman , Danielsson Kristina Gemzell 
Published: May 2019

Abstract
Background

A large proportion of abortion-related mortality and morbidity occur in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second trimester incomplete abortion to physicians who are few and unequally distributed with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second trimester post abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians.

Methods

A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size >12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or physician (control arm). Enrolled participants will receive 400mcg of misoprostol administered sublingually 3 hourly up to 5 doses within 24 hours at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 hours will undergo surgical uterine evacuation. Pre-discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications with follow up 14 days later to assess secondary outcomes. Analyses will be by Intention-to-Treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% CI) and equivalence established if it lies between the pre-defined range of -5% to +5%. Chi-square test will be used for comparison of outcome and t test used to compare mean values. P-values equal to or lower than 0.05 will be considered statistically significant.

Conclusions

Our study will provide evidence to inform national and international policies, standard care guidelines and training programmes curricula on treatment of second trimester incomplete abortion for improved access.
Spontaneous healing of an isolated posterior inferior cerebellar artery dissection without stroke: a case report
Authors: Kishi Yo 
Published: May 2019

Abstract
Background
Isolated posterior inferior cerebellar artery dissections can cause subarachnoid hemorrhages or infarctions. Surgical and endovascular treatments for hemorrhagic stroke cases and medical treatments using antithrombotic agents for ischemic stroke cases have been performed, but there are very few reports on nonstroke isolated posterior inferior cerebellar artery dissections, and the treatment strategy for nonstroke cases has not been established. This is the first detailed report on a spontaneously healed, isolated posterior inferior cerebellar artery dissection without stroke, followed by high-resolution MRI examinations.

Case presentation
A 48-year-old healthy male felt a severe, throbbing headache on the right side and came to our clinic on the fourth day following onset. MRI examinations revealed a right posterior inferior cerebellar artery dissection and showed no infarctions or hemorrhages. He was observed carefully with continuous monitoring of blood pressure, hydrated sufficiently, and given analgesic anti-inflammatory agents. Two weeks later, the dissected vessel’s diameter grew to the maximum size, though the patient’s headache rapidly improved around that day. Surgical or endovascular treatments for prevention of subarachnoid hemorrhage were recommended, but careful conservative therapy was continued in accordance with the patient’s wishes. Gradually, the dissection finding improved. Four months later, MRI examinations showed his right posterior inferior cerebellar artery was almost normal in size and shape.

Conclusions
This is the first detailed report on a nonstroke isolated posterior inferior cerebellar artery dissection that spontaneously occurred and healed, observed by serial high-resolution MRI examinations.
VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
Authors: Amstutz Alain , Lejone Thabo Ishmael , Khesa Lefu , Muhairwe Josephine , Nsakala Bienvenu Lengo , Tlali Katleho , Bresser Moniek , Tediosi Fabrizio , Kopo Mathebe , Kao Mpho , Klimkait Thomas , Battegay Manuel , Glass Tracy Renée , Labhardt Niklaus Daniel 
Published: May 2019

Abstract
BACKGROUND
There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access continuous care. This cluster-randomized clinical trial aims to evaluate the efficacy of a multicomponent differentiated ART delivery model (VIBRA model) after home-based same-day ART initiation in remote villages in Lesotho, Southern Africa.

METHODS
VIBRA (Village-Based Refill of ART) trial is a cluster-randomized, parallel-group, superiority clinical trial conducted in two districts of Lesotho, Southern Africa. Clusters (i.e. villages) are randomly as-signed to either the VIBRA model or standard of care, stratified by district, village size, and village access to the nearest health facility. Eligible individuals (HIV-positive, aged 10 years or older, not taking ART) found during community-based HIV testing campaigns are offered same-day home-based ART initiation. Intervention clusters offer a differentiated ART delivery package with two fea-tures: Firstly, drug-refill and follow-up through trained and supervised village health workers (VHW). Secondly, the option of receiving individually tailored adherence reminders and viral load result notifications via SMS. Standard of care applies for the control clusters, i.e. ART visits at the clinic and no SMS. The primary endpoint is viral suppression 12 months after enrolment. Second-ary endpoints include linkage to and engagement in care. Furthermore, safety and cost-effectiveness analyses plus qualitative research are planned. Minimum target sample size is 262 participants. Statistical analyses will follow CONSORT guidelines. VIBRA trial is linked to another trial, the HOSENG (HOme-based SElf-testiNG) trial, in the GET ON (GETing tOwards Ninety) re-search project.

DISCUSSION
VIBRA trial is among the first to evaluate ART delivery through VHW immediately after ART-initiation and it assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres similar to the VHW program in Lesotho, this model – if shown to be effective – has potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could further be modified to optimize impact.

TRIAL REGISTRATION
This trial has been registered at clinicaltrials.gov (NCT03630549) on August 15, 2018.
Enhancing &amp; Mobilizing the POtential for Wellness &amp; Emotional Resilience Among Surrogate Decision-Makers of ICU Patients (EMPOWER): Study protocol for a randomized controlled trial
Authors: Prigerson Holly G. , Viola Martin , Brewin Chris R. , Cox Christopher , Ouyang Daniel , Rogers Madeline , Pan Cynthia X. , Rabin Shayna , Xu Jiehui , Vaughan Susan , Gordon-Elliot Janna S. , Berlin David , Lief Lindsay , Lichtenthal Wendy G. 
Published: May 2019

Abstract
Background: Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience among Surrogate Decision-Makers of ICU Patients) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients’ quality of life and death and dying as well as surrogates’ mental health.

Methods: Clinician stakeholder and surrogate participant feedback (n=15), as well as results from an open trial (n =10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of posttraumatic stress disorder (PTSD), prolonged grief disorder (PGD) and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at one-month and three-months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment on. Participant exit interviews will be conducted at the three-month assessment time point and will be analyzed using qualitative thematic data analysis methods.

Discussion: The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application.
Depression in the nursing home: a cluster-randomized stepped-wedge study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)
Authors: Tesky Valentina Antonia , Schall Arthur , Schulze Ulrike , Stangier Ulrich , Oswald Frank , Knopf Monika , König Jochem , Blettner Maria , Arens Elisabeth , Pantel Johannes 
Published: May 2019

Abstract
Background

Depression is the second most common psychiatric illness in old people. Up to 30% of nursing home residents suffer from minor or major depression. Although depressive disorders in old age can be improved and even cured with adequate therapy, they often go unnoticed in nursing home residents and remain untreated. This highlights a striking deficit in health care and might results not only in lower quality of life among those concerned but also in poor physical functioning, premature mortality and increased hospitalization rates.

Methods

The aim of the interdisciplinary research project DAVOS is to implement an innovative and stepped structural case management program to improve depression treatment in nursing home residents by a modularized intervention and to assess it in terms of its effectiveness. Intervention modules are in line with recommendations given by the German national treatment guidelines for depression (S3 guidelines). Ten nursing homes in Frankfurt, Germany, will participate in the project which aims to recruit a study population of N = 380. The recruitment will continue throughout the trial (open cohort). Persons (>60 years) that live in a nursing home, have no medical diagnosis of dementia and can provide their informed consent to participate are eligible for inclusion in the study. Residents with a clinical diagnosis of dementia, alcohol or substance related disorders or other serious psychiatric illnesses will be excluded. DAVOS is a controlled cluster-randomized study that employs a stepped-wedge design.

Discussion

Our main hypothesis is that the implementation of the intervention will lead to a decline in the prevalence of depression and a reduction in depression symptoms among the home residents. In addition, we expect the intervention to have a positive impact on secondary outcomes such as level of functioning, quality of life and social participation. The project’s results can make an important contribution towards improving the health care of nursing home residents suffering from late-life depression.
Intestinal parasitic infections and associated factors among mentally disabled and non-disabled primary school students, Bahir Dar, Amhara Regional State, Ethiopia, 2018: A comparative cross-sectional study
Authors: Ayalew Agumas Fentahun , Achamyeleh Anemaw Asrat , Aniley Abebayehu Bitew , Admas Selamawit Mulat 
Published: May 2019

Abstract
Background: Intestinal parasitic infections are still common in low-income countries including Ethiopia, particularly in children due to low-quality drinking water, poor personal and environmental sanitation. Disabled individuals are excluded from most academic, economic, social and cultural opportunities, they are among the poorest and most marginalized of the whole world’s people. The aim of this study wasto assess the prevalenceof intestinal parasitic infections and associated factors among mentally disabled and non-disabled students at primary schools in Bahir Dar city, Amhara regional state, Ethiopia, 2018. Methods:A school-based Comparative cross-sectional study design was conductedfrom November 1 – 30, 2018. A total of 418 study participants, 104 mentally disabled and 314 non-disabled students were recruited through a simple random sampling technique. The collected data were coded, entered and cleaned with EpiData version 3.1 and analyzed using SPSS version 23. Multivariable logistic regression was conducted to identify factors associated with intestinal parasitic infections. The adjusted odds ratio with a 95% Confidence interval at a 5% level of significance was used to measure the strength of association. Results: The mean age of study participants was 14.05±3.66 and 11.96 ±2.94 for mentally disabled students and non-disabled students. Prevalence of parasitic infection was 56.70% (n=59) for mentally disabled students whereas 41.10%(n=129) for non-disabled students. Uncleanfingernails [AOR=2.42; 1.40,4.17], health checkups [AOR=1.87;1.16,3.02], hand washing with water only[AOR=2.48; 1.49,4.12],cooking and sanitation source of water [AOR=4.40;2.32,8.36],Grade(1-4)[AOR=2.27;1.41,3.67], sex [AOR=1.64;1.03,2.63] and Familysize>=7[AOR=2.74;1.25,5.99] were variables which showed statistically significant association with intestinal parasitic infections. Conclusion: The prevalence of intestinal parasitic infection was higher among mentally disabled students than non-disabled students. Unclean fingernails, health checkups, hand washing habits, source of water, family size, sex and Grade of students have had a statistically significant association with intestinal parasitic infections. Periodic medicinal treatment was needed twice a year for mentally disabled and once a year for non-disabled students.
Risk factors for viral hepatitis C infection in Rwanda: Results from a Nationwide Screening Program
Authors: Makuza Jean Damascene , Liu Carol Y , Ntihabose Corneille Killy , Dushimiyimana Donatha , Umuraza Sabine , Nisingizwe Marie Paul , Umutesi Justine , Serumondo Janvier , Mugeni Soline Dusabeyesu , Semakula Muhamed , Gupta Neil , Hellard Margaret , Nsanzimana Sabin 
Published: May 2019

Abstract
Background

The epidemiology and risk factors for hepatitis C virus (HCV) infection in Rwanda are not well known; however, this information is crucial to shaping the country’s public health approach to hepatitis C control.

Methods

A HCV screening campaign was conducted in the general population in 24 districts previously identified to have a high HCV disease burden at the time of sample collection, sociodemographic information and self-reported risk factors were collected. Bivariate and multivariate logistic regressions were conducted to assess risk factors independently associated with HCVAb seroprevalence.

Results

Out of a total of 326,263 individuals screened for HCVAb, 22183 (6.8%) were positive. In multivariate analysis, risk factors identified as statistically associated with HCVAb positivity include history of traditional operation or scarification (OR=1.091, 95% CI: 1.049-1.135), presence of viral hepatitis in the family (OR=1.268, 95% CI: 1.151-1.397), widowed or separated/divorced (OR=1.36, 95% CI: 1.257-1.471), South province (OR=1.978, 95% CI: 1.884-2.077) and age 65 years old and over (OR=4.857, 95% CI: 4.617-5.110). Ubudehe category 3 (OR=0.966, 95% CI: 0.927-1.008) and participants using RAMA insurance (OR=0.775, 95% CI: 0.704-0.854) had lower odds of HCV seropositivity.

Conclusions

Our findings provide important information for Rwanda’s strategy on prevention and case-finding. Future prevention interventions will aim to reduce transmission through targeted messaging around traditional healing practices and future case-finding will target individuals with a history of exposure or of older age.
Therapeutic effect of vasoactive intestinal peptide on form-deprived amblyopic kittens
Authors: Li Bo , Zou Yunchun , Li Liwen , Deng Hongwei , Mi Wei , Wang Xing , Yin Ximin 
Published: May 2019

Abstract
Background

Exploring the role of vasoactive intestinal peptide (VIP) in the lateral geniculate body (LGBd) in visual development and studying the therapeutic effect of VIP on amblyopic kittens.

Methods

Three-week-old domestic cats were divided into a control group (n = 10) and a monocular deprivation group (n = 20), with an eye mask covering the right eye of those in the deprived group. After pattern visual evoked potential (PVEP) recording confirmed the formation of monocular amblyopia, the left LGBd was isolated from 5 kittens in each group. The remaining control kittens continued to be raised, and the remaining deprivation group was divided into a VIP intervention group (n = 5), Sefsol (caprylic acid monoglyceride) intervention group (n = 5) and amblyopia non-intervention group (n = 5) after removal of the eye mask. Three weeks later, PVEPs, VIP immunohistochemistry and VIP mRNA expression in the left LGBd were compared across groups.

Results

At 6 weeks of age, there were significant differences in P100 wave latency and amplitude and VIP immunohistochemistry and in situ hybridization between the control group and the deprivation group (P < 0.05). After 3 weeks of the corresponding interventions, the latency and amplitude in the VIP intervention group were better than that in the Sefsol intervention group and amblyopia non-intervention group (P < 0.05). Furthermore, VIP treatment increased the number of immunohistochemical VIP-positive cells (P < 0.05) and the average optical density of positive cells (P > 0.05), as well as the number (P < 0.05) and average optical density of VIP mRNA-positive cells (P < 0.05).

Conclusions

VIP plays an important role in visual development. Nasal administration of VIP can improve the function of neurons in the LGBd of kittens and has a certain therapeutic effect on amblyopia.
The Effect of An Educational Program for Pregnant Women to Prevent Allergic Diseases In Infants: study protocol for a randomized controlled trial
Authors: Ito Rie , Nezu Yoko , Ishiguro Nao , Nakade Masato , Ishitsuka Yukiko , Naru Eiji 
Published: May 2019

Abstract
Background

Allergic diseases in infants have dramatically increased in developed countries during the past few decades. To date, extensive research has been done on risk factors for allergies in infancy, and preventive measures against it. However, the effect of the primary approach to preventing infants' allergy still remains limited.

The aim of this trial is to evaluate whether prenatal education interventions, including the latest public research results on allergic diseases, prevent the infant allergies onset.

Methods/Design

We designed a randomized, controlled, two-arm (standard prenatal education vs our education), parallel-group, assessor-blind, trial. A sample of 120 pregnant women will be recruited at Chiba Aiyukai Kinen hospital and allocation is by computer-generated randomization.

Pregnant women in the intervention arm participate in the childbirth education program established by the specialist and a pediatric allergy educator. The program was developed based on evidences supporting interventions on primary prevention, which are suggested to be beneficial to infant’s allergies in recent studies.

The primary objective of the study is to determine whether it is possible to establish effective behaviors for allergy prevention during early infancy in pregnant women who participate in an educational program developed by pediatric allergy specialists. Four months after birth, their behaviors will be compared against those of pregnant women who did not participate in the program.

Discussion

Allergies are common in many individuals worldwide, and can be present from babyhood through the person’s lifetime. One of the strong points of this study is that it will provide pregnant women with accumulated information on preventive knowledge against allergy that can be effective in some cases, and women can apply a combination of these behavior before and after pregnancy. The results of our program will be publicized to help change the behaviors of mothers, and if the program is effective for preventing allergies in infants, it will be disclosed worldwide as a new preventive measure for allergy in infants.
DNA methylation and miRNA-1296 act in concert to mediate spatiotemporal expression of KPNA7 during bovine oocyte and early embryonic development
Authors: Wang Lei , Hand Jacqelyn M. , Fu Liyuan , Smith George W. , Yao Jianbo 
Published: May 2019

Abstract
Background

Epigenetic regulation of oocyte-specific maternal factors is essential for oocyte and early embryonic development. KPNA7 is an oocyte-specific maternal factor, which controls transportation of nuclear proteins important for early embryonic development. To elucidate the epigenetic mechanisms involved in the controlled expression of KPNA7, both DNA methylation associated transcriptional silencing and miRNA-mediated mRNA degradation of KPNA7 were examined.

Results

Comparison of DNA methylation profiles at the proximal promoter of KPNA7 gene between oocyte and 6 different somatic tissues identified 3 oocyte-specific differentially methylated CpG sites. Expression of KPNA7 mRNA was reintroduced in bovine kidney-derived CCL2 cells after treatment with the methylation inhibitor, 5-aza-2-deoxycytidine (5-Aza). Analysis of the promoter region of KPNA7 gene in CCL2 cells treated with 5-Aza showed a lighter methylation rate in all the CpG sites. Bioinformatic analysis predicted 4 miRNA-1296 binding sites in the coding region of KPNA7 mRNA. Ectopic co-expression of miRNA-1296 and KPNA7 in HEK293 cells led to reduced expression of KPNA7 protein. Quantitative real time PCR analysis revealed that miRNA-1296 is expressed in oocytes and early stage embryos, and the expression reaches a peak level in 8-cell stage embryos, coincident with the time of embryonic genome activation and the start of declining of KPNA7 expression.

Conclusions

These results suggest that DNA methylation may account for oocyte-specific expression of KPNA7, and miRNA-1296 targeting the coding region of KPNA7 is a potential mechanism for KPNA7 transcript degradation during the maternal-to-zygotic transition.