bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial
Authors: Sartorelli Daniela Saes , Crivellenti Lívia Castro , Manochio-Pina Marina Garcia , Baroni Naiara Franco , Carvalho Mariana Rinaldi , Diez-Garcia Rosa Wanda , Franco Laércio Joel 
Published: January 2020

Abstract
Background
Evidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women. Additionally, the effect of the intervention on pregnancy outcomes, neonatal adiposity, and the child’s weight and height will be investigated.

Methods
This is a two-armed parallel randomized controlled trial that will be conducted at primary health units in Ribeirão Preto, SP, Brazil. Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included. The women will be randomly allocated into control (standard care) or intervention groups. Those enrolled in the intervention group will participate in three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities. The recruitment of the participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected. Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data will be obtained at baseline (up to the 16th week of gestation), and during a second assessment (34th to 36th gestational week). The neonate body composition will be estimated after birth, and data on pregnancy outcomes, weight and height of children at 6, 12 and 24 months of age will be further obtained from medical records.

Discussion
This will be the first randomized controlled trial to test the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in adult, overweight, pregnant women. Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child’s weight and height will be evaluated.

Trial registration
Registro Brasileiro de Ensaios Clínicos (Rebec) RBR-2w9bhc July 30th 2018 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-2w9bhc+), and RBR-7yx36h June 4th 2019 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-7yx36h+0.
The mediating role of social capital in the relationship between socioeconomic status and adolescent wellbeing: evidence from Ghana
Authors: Addae Evelyn Aboagye 
Published: January 2020

Abstract
Background
Social capital is generally portrayed to be protective of adolescents’ health and wellbeing against the effects of socioeconomic inequalities. However, few empirical evidence exist on this protective role of social capital regarding adolescents’ wellbeing in the low-and middle-income country (LMIC) context. This study examines the potential for social capital to be a protective health resource by investigating whether social capital can mediate the relationship between socioeconomic status (SES) and wellbeing of Ghanaian adolescents. It also examines how SES and social capital relate to different dimensions of adolescents’ wellbeing in different social contexts.

Methods
The study employed a cross-sectional survey involving a randomly selected 2068 adolescents (13-18 years) from 15 schools (8 Senior and 7 Junior High Schools) in Ghana. Relationships were assessed using multivariate regression models.

Results
Three measures of familial social capital (family sense of belonging, family autonomy support, and family control) were found to be important protective factors of both adolescents’ life satisfaction and happiness against the effects of socioeconomic status. One measure of school social capital (school sense of belonging) was found to augment adolescents’ wellbeing but played no mediating role in the SES-wellbeing relationship. A proportion of about 69 and 42% of the total effect of SES on happiness and life satisfaction were mediated by social capital respectively. Moreover, there were variations in how SES and social capital related to the different dimensions of adolescents’ wellbeing.

Conclusion
Social capital is a significant mechanism through which SES impacts the wellbeing of adolescents. Social capital is a potential protective health resource that can be utilised by public health policy to promote adolescents’ wellbeing irrespective of socioeconomic inequalities. Moreover, the role of the family (home) in promoting adolescents’ wellbeing is superior to that of school which prompts targeted policy interventions. For a holistic assessment of adolescents’ subjective wellbeing, both life evaluations (life satisfaction) and positive emotions (happiness) should be assessed concomitantly.
Pioglitazone and PPAR-γ modulating treatment in hypertensive and type 2 diabetic patients after ischemic stroke: a national cohort study
Authors: Liu Chi-Hung , Lee Tsong-Hai , Lin Yu-Sheng , Sung Pi-Shan , Wei Yi-Chia , Li Yan-Rong 
Published: January 2020

Abstract
Background and aim
Peroxisome proliferator-activated receptor-γ (PPAR-γ) modulating treatment may have cardiovascular benefits in type 2 diabetes mellitus (T2DM) patients after ischemic stroke (IS). However, whether there are additional benefits from intensive PPAR-γ modulating treatments in Asian patients with T2DM and hypertension (HTN) after IS remains unknown.

Methods
Between 2001 and 2013, patients admitted due to IS were identified from the National Health Insurance Research Database of Taiwan. Patients with T2DM and HTN using angiotensin receptor blockers were further included. Eligible patients were divided into two groups: (1) pioglitazone and (2) non-pioglitazone oral anti-diabetic agent groups. Propensity score matching (1:2) was used to balance the distribution of baseline characteristics, stroke severity and medications. The primary outcome was recurrent IS. Subgroup analysis for recurrent IS in pioglitazone and/or telmisartan users, the trend of IS risks across different PPAR-γ intensity treatments, and dose-dependent outcomes across different pioglitazone possession ratios were further studied. Statistical significance was set at p < 0.05 and p < 0.1 for clinical outcomes and interaction of subgroup analyses, respectively.

Results
There were 3190 and 32,645 patients in the pioglitazone and non-pioglitazone groups. Patients of the pioglitazone group had a lower risk of recurrent IS (subdistribution hazard ratio, 0.91; 95% confidence interval 0.84–0.99). Pioglitazone was also associated with reduced recurrent IS in patients who also used telmisartan (p for interaction = 0.071). A graded correlation was found a borderline significant trend between the intensity of PPAR-γ therapy and following IS (p = 0.076). The dose-dependent outcome also showed that a borderline significant trend that higher pioglitazone possession ratio was associated with a lower risk of recurrent IS (p = 0.068).

Conclusions
The current study suggests that the use of pioglitazone in type 2 diabetic and hypertensive IS patients is associated with fewer recurrent IS events in an Asian population. Concurrent telmisartan use or a higher pioglitazone possession ratio may have a trend of increased pleiotropic effects, which could possibly be related to higher PPAR-γ effects. Future studies are warranted to confirm or refute the clinical effects and the possible mechanism of more intensive PPAR-γ-modulating treatments.
Mineralization of the herbicide swep by a two-strain consortium and characterization of a new amidase for hydrolyzing swep
Authors: Zhang Long , Hang Ping , Zhou Xiyi , Dai Chen , He Ziyi , Jiang Jiandong 
Published: January 2020

Abstract
Background
Swep is an excellent carbamate herbicide that kills weeds by interfering with metabolic processes and inhibiting cell division at the growth point. Due to the large amount of use, swep residues in soil and water not only cause environmental pollution but also accumulate through the food chain, ultimately pose a threat to human health. This herbicide is degraded in soil mainly by microbial activity, but no studies on the biotransformation of swep have been reported.

Results
In this study, a consortium consisting of two bacterial strains, Comamonas sp. SWP-3 and Alicycliphilus sp. PH-34, was enriched from a contaminated soil sample and shown to be capable of mineralizing swep. Swep was first transformed by Comamonas sp. SWP-3 to the intermediate 3,4-dichloroaniline (3,4-DCA), after which 3,4-DCA was mineralized by Alicycliphilus sp. PH-34. An amidase gene, designated as ppa, responsible for the transformation of swep into 3,4-DCA was cloned from strain SWP-3. The expressed Ppa protein efficiently hydrolyzed swep and a number of other structural analogues, such as propanil, chlorpropham and propham. Ppa shared less than 50% identity with previously reported arylamidases and displayed maximal activity at 30 °C and pH 8.6. Gly449 and Val266 were confirmed by sequential error prone PCR to be the key catalytic sites for Ppa in the conversion of swep.

Conclusions
These results provide additional microbial resources for the potential remediation of swep-contaminated sites and add new insights into the catalytic mechanism of amidase in the hydrolysis of swep.
Role of HDACs in normal and malignant hematopoiesis
Authors: Wang Pan , Wang Zi , Liu Jing 
Published: January 2020

AbstractNormal hematopoiesis requires the accurate orchestration of lineage-specific patterns of gene expression at each stage of development, and epigenetic regulators play a vital role. Disordered epigenetic regulation has emerged as a key mechanism contributing to hematological malignancies. Histone deacetylases (HDACs) are a series of key transcriptional cofactors that regulate gene expression by deacetylation of lysine residues on histone and nonhistone proteins. In normal hematopoiesis, HDACs are widely involved in the development of various lineages. Their functions involve stemness maintenance, lineage commitment determination, cell differentiation and proliferation, etc. Deregulation of HDACs by abnormal expression or activity and oncogenic HDAC-containing transcriptional complexes are involved in hematological malignancies. Currently, HDAC family members are attractive targets for drug design, and a variety of HDAC-based combination strategies have been developed for the treatment of hematological malignancies. Drug resistance and limited therapeutic efficacy are key issues that hinder the clinical applications of HDAC inhibitors (HDACis). In this review, we summarize the current knowledge of how HDACs and HDAC-containing complexes function in normal hematopoiesis and highlight the etiology of HDACs in hematological malignancies. Moreover, the implication and drug resistance of HDACis are also discussed. This review presents an overview of the physiology and pathology of HDACs in the blood system.
Patient’s early satisfaction with care: a predictor of health-related quality of life change among outpatients with substance dependence
Authors: Müller Ophélie , Baumann Cédric , Di Patrizio Paolo , Viennet Sarah , Vlamynck Guillaume , Collet Laura , Clerc-Urmès Isabelle , Schwan Raymund , Bourion-Bédès Stéphanie 
Published: January 2020

Abstract
Background
Although research on health-related quality of life (HRQoL) has increased in the addiction field, few studies have focused on the determinants of HRQoL changes. This study aimed to describe dependent patients’ HRQoL changes at a 3-month follow-up and to assess whether satisfaction with care can predict those changes among outpatients starting care for alcohol or opioid dependence.

Methods
HRQoL was measured with the SF-12 at baseline and 3 months later in a prospective cohort of dependent outpatients. Satisfaction was assessed with the EQS-C early after inclusion. Data on sociodemographics, clinical characteristics and patients’ levels of anxiety and depression were also collected. A multivariable analysis was performed to identify factors associated with HRQoL changes in both the physical and mental component summary scores (PCS and MCS, respectively).

Results
Of the 172 patients included at baseline, a total of 136 patients assessed their satisfaction with care. The mean PCS and MCS scores were initially low, and HRQoL improvement was significant after 3 months for both the PCS and MCS. Never having been married (β = 5.5; p = 0.001) and a lower baseline PCS score (β = − 0.6; p < 0.0001) were associated with significant PCS improvement, whereas being legally compelled to undergo drug treatment (β = − 5.9; p = 0.02) was associated with less PCS change. Higher early satisfaction with care (β = 0.1; p = 0.02) and a lower baseline MCS score (β = − 0.7; p < 0.0001) were associated with significant MCS improvement.

Conclusion
The study supported the hypothesis that greater satisfaction with care may predict HRQoL improvement among dependent outpatients. Further studies are needed to understand the factors that affect patients’ early satisfaction to identify areas of improvement and thus improve HRQoL.
Effect of a bacteriophage T5virus on growth of Shiga toxigenic Escherichia coli and Salmonella strains in individual and mixed cultures
Authors: Niu Yan D. , Liu Hui , Johnson Roger P. , McAllister Tim A. , Stanford Kim 
Published: January 2020

AbstractA previously isolated a bacteriophage, vB_EcoS_AKFV33 of T5virus, demonstrated great potential in biocontrol of Shiga toxigenic Escherichia coli (STEC) O157. This study further evaluated its potential as a biocontrol agent in broth culture against other important non-O157 serogroups of STEC and Salmonella. AKFV33 was capable of lysing isolates of STEC serogroups O26 (n = 1), O145 (n = 1) and Salmonella enterica serovars (n = 6). In a broth culture microplate system, efficacy of AKFV33 for killing STEC O26:H11, O145:NM and Salmonella was improved (P < 0.05) at a lower multiplicity of infection and sampling time (6–10 h), when STEC O157:H7 was also included in the culture. This phage was able to simultaneously reduce numbers of STEC and Salmonella in mixtures with enhanced activity (P < 0.05) against O157:H7 and O26:H11, offering great promise for control of multiple zoonotic pathogens at both pre and post-harvest.
The forces driving clonal expansion of the HIV-1 latent reservoir
Authors: Liu Runxia , Simonetti Francesco R. , Ho Ya-Chi 
Published: January 2020

AbstractDespite antiretroviral therapy (ART) which halts HIV-1 replication and reduces plasma viral load to clinically undetectable levels, viral rebound inevitably occurs once ART is interrupted. HIV-1-infected cells can undergo clonal expansion, and these clonally expanded cells increase over time. Over 50% of latent reservoirs are maintained through clonal expansion. The clonally expanding HIV-1-infected cells, both in the blood and in the lymphoid tissues, contribute to viral rebound. The major drivers of clonal expansion of HIV-1-infected cells include antigen-driven proliferation, homeostatic proliferation and HIV-1 integration site-dependent proliferation. Here, we reviewed how viral, immunologic and genomic factors contribute to clonal expansion of HIV-1-infected cells, and how clonal expansion shapes the HIV-1 latent reservoir. Antigen-specific CD4+ T cells specific for different pathogens have different clonal expansion dynamics, depending on antigen exposure, cytokine profiles and exhaustion phenotypes. Homeostatic proliferation replenishes the HIV-1 latent reservoir without inducing viral expression and immune clearance. Integration site-dependent proliferation, a mechanism also deployed by other retroviruses, leads to slow but steady increase of HIV-1-infected cells harboring HIV-1 proviruses integrated in the same orientation at specific sites of certain cancer-related genes. Targeting clonally expanding HIV-1 latent reservoir without disrupting CD4+ T cell function is a top priority for HIV-1 eradication.
Comparison of quality of life in patients who underwent mechanical mitral valve replacement: star GK vs SJM
Authors: Huang Jiang-Shan , Xu Ning , Sun Kai-Peng , Hong Zhi-Nuan , Chen Liang-Wan , Kuo Yur-Ren , Chen Qiang 
Published: January 2020

Abstract
Background
We want to compare the impact on health-related quality of life (HRQoL) between the Star GK and the SJM valve in the Chinese population.

Methods
We retrospectively enrolled a total of 172 patients who had undergone mechanical mitral valve replacement (MVR) (SJM valve in 87 patients and Star GK valve in 85 patients) at our institution from January 2013 to December 2015. We measured the sound pressure level, and used 2 self-administered questionnaires and the Chinese version of SF-36 to measure the HRQoL and valve-specific questions to evaluate patient anxiety.

Results
The Star GK group and the SJM group were similar in age, gender, body surface area, diameter of the implanted valve, underlying disease and current median NYHA class. Regarding the valve sound pressure perceived 1 year after operation, the SJM valve was slightly quieter than the Star GK valve, but the sound pressures of the two valves showed no significant differences. No significant differences in any of the eight subscales of the SF-36 were found between the two groups.

Conclusions
The present study suggests that the Star GK valve is similar to the SJM valve in its impact on HRQoL and audibility of mechanical sound in the Chinese population.
Anillin regulates breast cancer cell migration, growth, and metastasis by non-canonical mechanisms involving control of cell stemness and differentiation
Authors: Wang Dongdong , Naydenov Nayden G. , Dozmorov Mikhail G. , Koblinski Jennifer E. , Ivanov Andrei I. 
Published: January 2020

Abstract
Background
Breast cancer metastasis is driven by a profound remodeling of the cytoskeleton that enables efficient cell migration and invasion. Anillin is a unique scaffolding protein regulating major cytoskeletal structures, such as actin filaments, microtubules, and septin polymers. It is markedly overexpressed in breast cancer, and high anillin expression is associated with poor prognosis. The aim of this study was to investigate the role of anillin in breast cancer cell migration, growth, and metastasis.

Methods
CRISPR/Cas9 technology was used to deplete anillin in highly metastatic MDA-MB-231 and BT549 cells and to overexpress it in poorly invasive MCF10AneoT cells. The effects of anillin depletion and overexpression on breast cancer cell motility in vitro were examined by wound healing and Matrigel invasion assays. Assembly of the actin cytoskeleton and matrix adhesion were evaluated by immunofluorescence labeling and confocal microscopy. In vitro tumor development was monitored by soft agar growth assays, whereas cancer stem cells were examined using a mammosphere formation assay and flow cytometry. The effects of anillin knockout on tumor growth and metastasis in vivo were determined by injecting control and anillin-depleted breast cancer cells into NSG mice.

Results
Loss-of-function and gain-of-function studies demonstrated that anillin is necessary and sufficient to accelerate migration, invasion, and anchorage-independent growth of breast cancer cells in vitro. Furthermore, loss of anillin markedly attenuated primary tumor growth and metastasis of breast cancer in vivo. In breast cancer cells, anillin was localized in the nucleus; however, knockout of this protein affected the cytoplasmic/cortical events, e.g., the organization of actin cytoskeleton and cell-matrix adhesions. Furthermore, we observed a global transcriptional reprogramming of anillin-depleted breast cancer cells that resulted in suppression of their stemness and induction of the mesenchymal to epithelial trans-differentiation. Such trans-differentiation was manifested by the upregulation of basal keratins along with the increased expression of E-cadherin and P-cadherin. Knockdown of E-cadherin restored the impaired migration and invasion of anillin-deficient breast cancer cells.

Conclusion
Our study demonstrates that anillin plays essential roles in promoting breast cancer growth and metastatic dissemination in vitro and in vivo and unravels novel functions of anillin in regulating breast cancer stemness and differentiation.
Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial
Authors: Dahanayake Jeevani Maheshika , Perera Pathirage Kamal , Galappaththy Priyadarshani , Samaranayake Dulani 
Published: January 2020

Abstract
Background
Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis.

Study design
This is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze-dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the three arms prior to visit 1, at the end of 28 days, and end of the first and second months of follow-up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points.

Discussion
This clinical trial will be able to provide evidence-based scientific data on Ayurvedic dosage form, TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions.

Trial registration
ISRCTN18149439 (6 May 2019).
Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”
Authors: Maulik Mohua , Gupta Jyotsna , Juneja Atul , Adhikari Tulsi , Sharma Saurabh , Panchal Yashmin , Yadav Neha , Rao Mendu Vishnu Vardhana 
Published: January 2020

AbstractAn article published in this journal analyses the deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India. We wish to rebut some of the inferences and highlight the pitfalls of a purely automated analysis of registry data as posited by the authors.