Pilot study of a ketogenic diet in relapsing-remitting MS

ObjectiveTo assess the safety and tolerability of a modified Atkins diet (KDMAD), a type of ketogenic diet (KD), in subjects with relapsing MS while exploring potential benefits of KDs in MS.MethodsTwenty subjects with relapsing MS enrolled into a 6-month, single-arm, open-label study of the KDMAD. Adherence to KDMAD was objectively monitored by daily urine ketone testing. Fatigue and depression scores and fasting adipokines were obtained at baseline and on diet. Brain MRI was obtained at baseline and 6 months. Intention to treat was used for primary data analysis, and a per-protocol approach was used for secondary analysis.ResultsNo subject experienced worsening disease on diet. Nineteen subjects (95%) adhered to KDMAD for 3 months and 15 (75%) adhered for 6 months. Anthropometric improvements were noted on KDMAD, with reductions in body mass index and total fat mass (p < 0.0001). Fatigue (p = 0.002) and depression scores (p = 0.003) were improved. Serologic leptin was significantly lower at 3 months (p < 0.0001) on diet.ConclusionsKDMAD is safe, feasible to study, and well tolerated in subjects with relapsing MS. KDMAD improves fatigue and depression while also promoting weight loss and reducing serologic proinflammatory adipokines.Classification of evidenceThe study is rated Class IV because of the absence of a non-KD control group.

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Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

Infection Control and Hospital Epidemiology ◽

10.1086/661285 ◽

2011 ◽

Vol 32 (9) ◽

pp. 872-880 ◽

Cited By ~ 89

Author(s):

Stephanie A. Fritz ◽

Bernard C. Camins ◽

Kimberly A. Eisenstein ◽

Joseph M. Fritz ◽

Emma K. Epplin ◽

...

Keyword(s):

Staphylococcus Aureus ◽

Soft Tissue ◽

Controlled Trial ◽

Control Group ◽

Open Label ◽

Intention To Treat ◽

Intranasal Mupirocin ◽

Mupirocin Ointment ◽

Hygiene Education ◽

To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

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Impact of Microfinance on Income and Employment in Pakistan: A Primary Data Analysis

Review of Economics and Development Studies ◽

10.26710/reads.v3i1.166 ◽

2017 ◽

Vol 3 (1) ◽

pp. 69-82

Author(s):

Shahina Imran ◽

Rana M. Imran Arshad

Keyword(s):

Household Income ◽

Positive Impact ◽

Small Enterprise ◽

Local Context ◽

Primary Data ◽

Control Group ◽

Primary Data Analysis ◽

Gender Education ◽

Household Assets ◽

The Impact

Purpose: This paper investigates impact of microfinance on household income and employment. It is a primary data research conducted in the Bahawalpur division, Pakistan. The study employed the tool developed by Assessing the Impact of Microenterprise Services (AIMS) and Small Enterprise, Education and Promotion (SEEP). The tool has been modified in local context. The sample consists of 1524 respondents, out of which 773 are established clients (treatment group) and 751 are incoming ones (control group), belonging to different microfinance providers of Pakistan. Independent Sample T-Test and Multiple regressions have been used for analysis. The regression analysis shows that participation to microfinance program has strong positive impact on household income while very minute positive impact on employment. Other independent variables such as prior access to any other loan, micro saving, household assets, age of respondent, gender, education and household size have positive impact on household income but a mixed impact on income generating activities.

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DIPG-54. A NON-INVASIVE PROGNOSTIC CIRCULATING miRNAs SIGNATURE IN DIFFUSE INTRINSIC PONTINE GLIOMAS

Neuro-Oncology ◽

10.1093/neuonc/noaa222.099 ◽

2020 ◽

Vol 22 (Supplement_3) ◽

pp. iii297-iii297

Author(s):

Maria Federica Iannò ◽

Elisabetta Schiavello ◽

Andrea Carenzo ◽

Andrea Anichini ◽

Veronica Biassoni ◽

...

Keyword(s):

Objective Response ◽

Case Series ◽

Low Risk ◽

Primary Data ◽

P Value ◽

Open Label ◽

Non Invasive ◽

Primary Data Analysis ◽

Risk Patients ◽

Diffuse Intrinsic Pontine Gliomas

Abstract Diffuse intrinsic pontine gliomas (DIPG) are the most common brainstem tumors of childhood and represent one of the most challenging paediatric tumours to treat. A non-randomized, open label phase II pilot study was conducted at Fondazione IRCCS Istituto Nazionale Tumori (Milan) to assess the efficacy in terms of objective response rate according to the RECIST criteria of combining nimotuzumab and vinorelbine with radiation in newly-diagnosed DIPG. Serum specimens were collected at baseline. microRNA expression profiling was performed using Agilent platform and Human miRNA SureSelect 8x60K containing 2006 miRNAs annotated on miRBase19.0. Primary data analysis yielded a matrix containing 330 detectable miRNA. Association with PFS allowed us to disclose a signature of 10 miRNAs able to stratify high and low risk patients (HR=4.33, 95%CI 1.49–12.54; p=4.27E-05). To test the 10 ct-miRNA model performance, we collected an independent cohort of the same sample size (n=24) and we derived the index values and risk stratification. The distribution of index values covers a range similar to the discovery cohort. Imposing the signature threshold patients were divided in high/low risk and Kaplan-Meier curves confirmed the different PFS time for the two groups with HR=3.5 (95%CI: 1.8–8.01, p-value=0.0002) for the high-risk patients, reaching AUC=0.833. Our signature is a biomarker based on non-invasive procedures for prognosis able to enter into clinical practice. Further validation on multicenter case series is warranted.

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Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa241 ◽

2020 ◽

Vol 7 (7) ◽

Cited By ~ 13

Author(s):

Jun Chen ◽

Lu Xia ◽

Li Liu ◽

Qingnian Xu ◽

Yun Ling ◽

...

Keyword(s):

Antiviral Activity ◽

Interferon Alpha ◽

Clearance Rate ◽

Standard Of Care ◽

Study Groups ◽

Control Group ◽

Open Label ◽

Intention To Treat ◽

Interferon Alpha 2B ◽

And Control

Abstract Background We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients. Methods In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)–confirmed COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274). Results From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 ± 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2–5) days after onset of symptoms. The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups (P = .72), respectively. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable (P = 1.0). The frequencies of adverse events in the 2 groups were comparable. Conclusions Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.

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GLUCOCOVID: A controlled trial of methylprednisolone in adults hospitalized with COVID-19 pneumonia

10.1101/2020.06.17.20133579 ◽

2020 ◽

Cited By ~ 16

Author(s):

Luis Corral-Gudino ◽

Alberto Bahamonde ◽

Francisco Arnaiz-Revillas ◽

Julia Gómez-Barquero ◽

Jesica Abadía-Otero ◽

...

Keyword(s):

Controlled Trial ◽

Composite Endpoint ◽

Standard Of Care ◽

Control Group ◽

Open Label ◽

Protein Levels ◽

Intention To Treat ◽

Reactive Protein ◽

Short Course ◽

Stratified Analysis

ABSTRACTBackgroundWe aimed to determine whether a 6-day course of intravenous methylprednisolone (MP) improves outcome in patients with SARS CoV-2 infection at risk of developing Acute Respiratory Distress Syndrome (ARDS).MethodsMulticentric, partially randomized, preference, open-label trial, including adults with COVID-19 pneumonia, impaired gas exchange and biochemical evidence of hyper-inflammation. Patients were assigned to standard of care (SOC), or SOC plus intravenous MP [40mg/12h 3 days, then 20mg/12h 3 days]. The primary endpoint was a composite of death, admission to the intensive care unit (ICU) or requirement of non-invasive ventilation (NIV).ResultsWe analyzed 85 patients (34, randomized to MP; 22, assigned to MP by clinician’s preference; 29, control group). Patients’ age (mean 68±12 yr) was related to outcome. The use of MP was associated with a reduced risk of the composite endpoint in the intention-to-treat, age-stratified analysis (combined risk ratio -RR-0.55 [95% CI 0.33-0.91]; p=0.024). In the per-protocol analysis, RR was 0.11 (0.01-0.83) in patients aged 72 yr or less, 0.61 (0.32-1.17) in those over 72 yr, and 0.37 (0.19-0.74, p=0.0037) in the whole group after age-adjustment by stratification. The decrease in C-reactive protein levels was more pronounced in the MP group (p=0.0003). Hyperglycemia was more frequent in the MP group.ConclusionsA short course of MP had a beneficial effect on the clinical outcome of severe COVID-19 pneumonia, decreasing the risk of the composite end point of admission to ICU, NIV or death.

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Spin in the neurosurgical trauma literature: prevalence and associated factors – a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-046602 ◽

2022 ◽

Vol 12 (1) ◽

pp. e046602

Author(s):

João Vitor Miranda Porto Oliveira ◽

André Luiz Freitas Oliveira Júnior ◽

Angelos G Kolias ◽

Wellingson S Paiva ◽

Davi Jorge Fontoura Solla

Keyword(s):

Systematic Review ◽

Associated Factors ◽

Primary Outcome ◽

Secondary Analysis ◽

Primary Data ◽

Outcome Analysis ◽

Future Research ◽

Intention To Treat ◽

Pubmed Database ◽

Meta Analyses

IntroductionSpin is defined as an inaccurate interpretation of results, intentionally or not, leading to equivocal conclusions and misdirecting readers to look at the data in an overly optimistic way. Previous studies have shown a high prevalence of spin in scientific papers and this systematic review aims to investigate the nature and prevalence of spin in the neurosurgical trauma literature. Any associated factors will be identified to guide future research practice recommendations.Methods and analysisThe Preferred Reporting Item for Systematic Reviews and Meta-Analyses recommendations will be followed. Randomised clinical trials (RCTs) that enrolled only patients with traumatic brain injury and investigated any type of intervention (surgical or non-surgical) will be eligible for inclusion. The MEDLINE/PubMed database will be searched for articles in English published in 15 top-ranked journals. Spin will be defined as (1) a focus on statistically significant results not based on the primary outcome; (2) interpreting statistically non-significant results for a superiority analysis of the primary outcome; (3) claiming or emphasising the beneficial effect of the treatment despite statistically non-significant results; (4) conclusion focused in the per-protocol or as-treated analysis instead of the intention-to-treat results; (5) incorrect statistical analysis; (6) republication of a significant secondary analysis without proper acknowledgement of the primary outcome analysis result. Traditional descriptive statistics will be used to present RCT characteristics. Standardised differences between the groups with or without spin will be calculated. The variables with a standardised difference equal or above 0.2 and 0.5 will be considered weakly and strongly associated with spin, respectively.Ethics and disseminationThis study will not involve primary data collection and patients will not be involved.Trial registration number10.17605/OSF.IO/H3FGY.

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Which Data to Meta-Analyze, and How?

Zeitschrift für Psychologie ◽

10.1027/2151-2604/a000357 ◽

2019 ◽

Vol 227 (1) ◽

pp. 64-82 ◽

Cited By ~ 3

Author(s):

Martin Voracek ◽

Michael Kossmeier ◽

Ulrich S. Tran

Keyword(s):

Empirical Research ◽

Meta Analysis ◽

Curve Analysis ◽

Research Progress ◽

Primary Data ◽

Statistical Procedures ◽

Graphical Displays ◽

Primary Data Analysis ◽

Meta Analyses ◽

Data Analytic

Abstract. Which data to analyze, and how, are fundamental questions of all empirical research. As there are always numerous flexibilities in data-analytic decisions (a “garden of forking paths”), this poses perennial problems to all empirical research. Specification-curve analysis and multiverse analysis have recently been proposed as solutions to these issues. Building on the structural analogies between primary data analysis and meta-analysis, we transform and adapt these approaches to the meta-analytic level, in tandem with combinatorial meta-analysis. We explain the rationale of this idea, suggest descriptive and inferential statistical procedures, as well as graphical displays, provide code for meta-analytic practitioners to generate and use these, and present a fully worked real example from digit ratio (2D:4D) research, totaling 1,592 meta-analytic specifications. Specification-curve and multiverse meta-analysis holds promise to resolve conflicting meta-analyses, contested evidence, controversial empirical literatures, and polarized research, and to mitigate the associated detrimental effects of these phenomena on research progress.

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‘Sometimes you need to think outside their boxes’: An Examination of the Voice of Black Minority Ethnic Women in Post-Devolution Scotland

Scottish Affairs ◽

10.3366/scot.2014.0042 ◽

2014 ◽

Vol 23 (4) ◽

pp. 419-444

Author(s):

Josephine Casserly

Keyword(s):

Qualitative Interviews ◽

Secondary Analysis ◽

Third Sector ◽

Political Life ◽

Primary Data ◽

Political Processes ◽

Focus Group Data ◽

Feminist Theories ◽

The Voice ◽

Minority Ethnic

This article explores the voice of black minority ethnic (BME) women in devolved Scotland. Particular attention is given to examining multicultural policies and devolved political processes and how these impact on the position of BME women in the political life of Scotland. The study is based on secondary analysis of existing survey and focus group data, and primary data drawn from qualitative interviews conducted with a sample of respondents from political and non-governmental organisations. Drawing on feminist theories of multiculturalism, culture is perceived as dynamic and contested and the research depicts BME women as agents engaged in shaping Scotland and their own cultures. The findings show that devolution has created a political opportunity structure more favourable to the voices of BME women. However, this voice remains quiet and is limited by barriers within and outside of BME communities. The research also highlights the role of third sector organisations in enabling the voice of BME women. The author concludes by arguing that successive devolved governments’ promotion of multiculturalism in Scotland has benefited BME women but with important limitations.

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University As A Social Entreprise:Modelling Enterprise 3.0 Application In Engineering Curriculum

Balkan Region Conference on Engineering and Business Education ◽

10.2478/cplbu-2014-0063 ◽

2014 ◽

Vol 1 (1) ◽

pp. 393-398

Author(s):

Andreas Ahrens ◽

Olaf Bassus ◽

Jeļena Zaščerinska

Keyword(s):

Social Enterprise ◽

Primary Data ◽

Engineering Curriculum ◽

Positive Direction ◽

Social Agent ◽

Primary Data Analysis ◽

The Social ◽

Technical Expert ◽

Knowledge And Attitude ◽

Broad Understanding

AbstractUniversity as a social enterprise has become the dominant response to the challenge of bringing up an engineer as a first-rate technical expert who acts as a social agent, rather than just a technician, with a “broad understanding of the social and philosophical context in which he will work” [3]. Aim of the research is to analyze student engineers' Enterprise 3.0 application in engineering curriculum. The meaning of the key concepts of university as a social enterprise, engineering curriculum and Enterprise 3.0 is studied. Explorative research has been used. The empirical study was conducted at Riga Technical University, Riga, Latvia, in 2011. Descriptive statistics was implemented for primary data analysis. The findings of the research allow drawing the conclusions on the favourable context of Enterprise 3.0 application in engineering curriculum as the student engineers' knowledge and attitude towards Enterprise 3.0 application are positive. Direction of further research are proposed.

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Randomized Trial for Weight Loss Using a Digital Therapeutic Application

Journal of Diabetes Science and Technology ◽

10.1177/19322968211000815 ◽

2021 ◽

pp. 193229682110008

Author(s):

Tryggvi Thorgeirsson ◽

Johanna E. Torfadottir ◽

Erlendur Egilsson ◽

Saemundur Oddsson ◽

Thrudur Gunnarsdottir ◽

...

Keyword(s):

Weight Loss ◽

Mobile Application ◽

Intervention Group ◽

Lifestyle Change ◽

Noncommunicable Diseases ◽

Control Group ◽

Intention To Treat ◽

Protocol Group ◽

Lifestyle Program ◽

Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

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