bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults
Authors: Kemppinen Anu , Howell Carol , Allgar Victoria , Dodd Matthew , Gregson John , Knowles Charles , McLaughlin John , Pandya Preeti , Whorwell Peter , Markaryan Elena , Yiannakou Yan 
Published: July 2019

Abstract
Background

Irritable Bowel Syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D.

Methods and design

430 participants with IBS-D will be recruited from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period, will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers, and gut-related measurements from magnetic resonance imaging data.

Discussion

This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.
Effectiveness of Checklist based Box system Interventions (CBBSI) versus routine care on improving utilization of Maternal Health Service in North West, Ethiopia: Cluster Randomized Controlled Trial
Authors: Belete Netsanet , Gerbaba Mulusew , Tura Gurmesa 
Published: July 2019

Abstract
Background -

Maternal mortality is still high in Ethiopia. Antenatal care, use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low and middle income countries including Ethiopia, utilization of these key services are not enough to deliver the recommended preventive, promotive and curative services. The aim of this study is to examine the effectiveness of checklist based box system interventions on improving maternal health service utilization.

Methods -

A community level cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist based box system interventions over the routine standard of care. The intervention will use health extension program and provided by health extension workers and midwives, using a special type of health education scheduling and service utilization monitoring boxes, placed at health posts and health centers respectively. For this, 1,200 pregnant mothers, below 16 weeks of gestation, will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. In a two weeks base, review of dropouts will be conducted at each intervention health center. Then intervention health posts (supervised by intervention health center) will be communicated for each dropout. Then, health extension workers will provide health education, using a person-centered manual prepared for this purpose. Data will be collected using ODK-Collect and analyzed using STATA version 13.0. Data will be analyzed by intention to treat analysis. Risk ration will be computed at cluster level and the summary will be compared using t-test. Outcomes between intervention and control groups will be compared with random effects logistic regression models.

Discussion -

The authors of this study expect that, the study will generate evidence on the effectiveness of checklist based box system interventions on improving utilization of maternal health care service, that are strong enough to inform policies in the country.
Evaluation of the Influenza Sentinel Surveillance System in the Democratic Republic of Congo, 2012-2015
Authors: Babakazo Pelagie Diambalula , Kabamba-Tshilobo Joelle , Wemakoy Emile Okitolonda , Lubula Léopold , Manya Léonie Kitoko , Ilunga Benoit Kebela , Disasuani Wally , Nkwembe Edith , Kavunga-Membo Hugo , Changachanga Jean-Claude , Muhemedi Saleh , Tamfum Jean-Jacques Muyembe , Tempia Stefano 
Published: July 2019

Abstract
Background

The World Health Organization recommends periodic evaluations of influenza surveillance systems to identify areas for improvement and provide evidence of data reliability for policymaking. However, data about the performance of established influenza surveillance systems are limited in Africa, including in the Democratic Republic of Congo (DRC).

Methods

We used the Centers for Disease Control and Prevention guidelines to evaluate the performance of the influenza sentinel surveillance system (ISSS) in DRC during 2012-2015. The performance of the system was evaluated using eight surveillance attributes: (i) data quality and completeness for key variables, (ii) timeliness, (iii) representativeness, (iv) flexibility, (v) simplicity, (vi) acceptability, (vii) stability and (viii) utility. For each attribute, specific indicators were developed and described using quantitative and qualitative methods. Scores for each indicator were as follows: <60% weak performance; 60-79% moderate performance; ≥80% good performance.

Results

During 2012-2015, we enrolled and tested 4,339 patients with influenza-like illness (ILI) and 2,869 patients with severe acute respiratory illness (SARI) from 11 sentinel sites situated in 5 of 11 provinces. Influenza viruses were detected in 446 (10.3%) samples from patients with ILI and in 151 (5.5%) samples from patients with SARI with higher detection during December-May. Data quality and completeness was >90% for all evaluated indicators. Other strengths of the system were timeliness, representativeness, simplicity, stability and utility that scored >70% each. Flexibility and acceptability had moderate to week performance. It was reported that the ISSS contributed to: (i) a better understanding of the epidemiology, circulating patterns and proportional contribution of influenza virus among patients with ILI or SARI; (ii) acquisition of new key competences related to influenza surveillance and diagnosis; and (iii) continuous education of surveillance staff and clinicians at sentinel sites about influenza. However, due to limited resources no actions were undertaken to mitigate the impact of seasonal influenza epidemics.

Conclusions

The system performed overall satisfactorily and provided reliable and timely data about influenza circulation in DRC. The simplicity of the system contributed to its stability. A better use of the available data could be made to inform and promote prevention interventions especially among the most vulnerable groups.
Cysteine-cysteine chemokine receptor 5 (CCR5) profile of HIV-infected subjects attending University of Calabar Teaching Hospital, Calabar, Southern Nigeria
Authors: Ekere Ekerette Friday , Useh Monday F. , Okoroiwu Henshaw Uchechi , Mirabeau Tatfeng Youtchou 
Published: July 2019

Abstract
Background

Cysteine-cysteine chemokine receptor 5 is the main HIV co-receptor involved in the virus and cell-to-cell spread. A variant of the CCR5 gene known as CCR5-Δ32 which is a product of 32 base pair deletion in the gene plays critical role in the infection and progression to AIDS. The study was done to determine the CCR5 genotype of HIV-infected subjects attending University of Calabar Teaching Hospital, Calabar.

Methods

A total of 100 subjects attending HIV clinic, University of Calabar Teaching Hospital were purposively recruited for this study. DNA was extracted from each sample using the quick gDNA miniprep DNA extraction kit. Polymerase chain reaction was used in amplification of CCR5 gene in each DNA in a 9700 ABI Thermo cycler and then resolved on 4% agarose gel electrophoresis.

Result

Out of the 100 samples assessed, 100 (100%) were homozygous for the CCR5 wild type gene (CCR5-wt), while none (0%) was homozygous for the CCR5-Δ32 (mutant type), and heterozygosity was not observed.

Conclusion

This study observed absence of CCR5-Δ32 deletion gene among the studied subjects in Calabar. This implies lack of genetic advantage in HIV infection and possible rapid progression towards AIDS if other precautions are not checked.
Intra-abdominal infections: the role of different classifications on the selection of the best antibiotic treatment
Authors: Nunes João Silva , Cardoso Teresa Maria Costa 
Published: July 2019

Abstract
Background

Intra-abdominal infections (IAIs) represent a most frequent gastrointestinal emergency and serious cause of morbimortality. A full classification including all facets of IAIs does not exist. Two classifications are used to subdivide IAIs: uncomplicated or complicated, considering infection extent; and community-acquired, healthcare-associated or hospital-acquired, regarding place of acquisition. Adequacy of initial empirical antibiotic therapy prescribed is an essential need. Inadequate antibiotic therapy is associated with treatment failure and increased mortality. This study was designed to determine accuracy of different classifications of IAIs to identify infections by pathogens sensitive to current treatment guidelines helping in selection of best antibiotic therapy.

Methods

Retrospective cohort study including all adult patients discharged from hospital with diagnosis of IAI between 1st of January and 31st of October, 2016. All variables potentially associated with pre-defined outcomes: infection by a pathogen sensitive to non-pseudomonal cephalosporin or ciprofloxacin plus metronidazol (ATB 1, primary outcome), sensitive to piperacillin-tazobactam (ATB 2) and hospital mortality (secondary outcomes) were studied through logistic regression. Accuracy of the models was assessed by area under receiver operating characteristics (AUROC) curve and calibration was tested using Hosmer-Lemeshow goodness-of-fit test.

Results

Of 1804 patients screened 154 met inclusion criteria. Sensitivity to ATB 1 was independently associated with male gender (adjusted OR=2.612) and previous invasive procedures in last year (adjusted OR=0.424) (AUROC curve=0,65). Sensitivity to ATB 2 was independently associated with liver disease (adjusted OR=3.580) and post-operative infections (adjusted OR=2.944) (AUROC curve=0.604). Hospital mortality was independently associated with age≥70 (adjusted OR=4.677), solid tumor (adjusted OR=3.127) and sensitivity to non-pseudomonal cephalosporin or ciprofloxacin plus metronidazole (adjusted OR=0.368).
Accuracy of pre-existing classifications to identify infection by a pathogen sensitive to ATB 1 was 0.59 considering place of acquisition, 0.61 infection extent and 0.57 local of infection, for ATB 2 it was 0.66, 0.50 and 0.57, respectively.

Conclusion

None of existent classifications had a good discriminative power to identify IAIs caused by pathogens sensitive to current antibiotic treatment recommendations. A new classification including patients individual characteristics like those included in current model might have a higher potential to distinguish IAIs by resistant pathogens allowing a better choice of empiric antibiotic therapy.
Stakeholders’ recommendations for implementing HIV self-testing and secondary distribution of HIV self-testing for male partners of Option B+ clients in Haiti as an assisted partner service strategy: a qualitative study
Authors: Conserve Donaldson Fadael , Michel Jacob , Demes Joseph Emmanuel Adrien , Chéry Jean Marxcime , Balan Jean-Gabriel , Choko Augustine , François Kesner , Puttkammer Nancy 
Published: July 2019

Abstract
Background

Despite significant public health efforts, HIV testing remains low among men in Haiti. HIV self-testing (HIVST), which allows people to test in private, is an effective strategy for increasing HIV testing among men. Secondary distribution of HIVST to male partners of women living with HIV (WLWH) is one promising assisted partner services strategy to address the low HIV testing rate among men in Haiti. However, little research has been conducted on how to implement HIVST in the Caribbean. The purpose of this study was to assess stakeholders’ perspectives towards HIVST and to obtain their recommendations for how to implementing HIVST in Haiti to reach male partners of Option B+ clients.

Methods

Sixteen key informant interviews and nine focus groups with 44 healthcare workers (HCWs), 31 Option B+ clients, and 13 men were carried out in Haiti. Key informants were representatives of the Ministry of Health and of a non-governmental agency involved in HIV partner services. HCWs included program leads and staff members from the HIV care and treatment program, the Option B+ program, the community health service program, and the HIV counseling and testing services from 2 hospitals.

Results

Perceived HIVST advantages included an increase in the number of people who would learn their HIV status and start treatment. Perceived disadvantages were lack of support to ensure self-testers initiate treatment, uncertainty about male partner’s reaction, risk of violence towards a woman by a man after having received an HIVST kit from her, and the inability of a woman to counsel a man in case his self-test result is positive. Recommendations for implementing HIVST and secondary distribution of HIVST included coupling HIVST distribution with public information, education, and communication through media and social marketing; relying on community health workers to mediate the use of HIVST and ensure linkage to care; and piloting HIVST programs on a small scale.

Conclusions

HIVST is an appropriate and feasible HIV prevention strategy for men and women. Our findings indicate that more research is needed to determine and pilot how best to implement HIVST and secondary distribution of HIVST by Option B+ clients in Haiti.
Burden of viral hepatitis caused by specific aetiologies in China, 1990-2016: findings from the GBD 2016
Authors: Li Man , Wang Zhuo-qun , Zhang Lu , Zheng Hao , Zhou Mai-geng , Liu Dian-wu 
Published: July 2019

Abstract
Purpose

The aim of this study is to quantify the burden caused by viral hepatitis in China from 1990 to 2016. Methods: Data from the GBD 2016 study were extracted to calculate incidence, prevalence and disability-adjusted life years (DALYs). Trends in DALYs were assessed in 33 provinces/regions. Results: From 1990 to 2016, the total incidence of hepatitis decreased by 88.5%. However, the prevalence of hepatitis (counts in thousands), increased by 37.6% from 153,856 (95% UI: 136,047-172,319) in 1990 to 211,721 (95% UI: 179,776-240,981) in 2016, with age-standardized prevalence rates changing slightly. The number and age-standardized prevalence rates increased by 35.9% and 1.6% for hepatitis B and by 81.8% and 30.4% for hepatitis C, respectively. Guangxi, Guangdong and Hainan had the highest age-standardized prevalence rates (≥16,500 per 100,000). Tibet, Qinghai and Gansu had the highest age-standardized DALYs rates (≥40 per 100,000). The largest absolute number of DALYs was observed in the 15-49 year age group in 2016. The highest rate of DALYs occurred in males aged 50-69 years and in females aged ≧70 years. Conclusion: The incidence and DALYs of viral hepatitis decreased dramatically from 1990 to 2016. However, the prevalence still remains at a high level, which may result in heavy burdens in the future.
Comparison of weight-based versus standard dosing of tranexamic acid for blood loss and transfusion amount in knee arthroplasty without tourniquet
Authors: guler olcay , Çarkçı Engin , Çerci Mehmet Halis , Gümüşsuyu Gürkan , Öztürk Çağatay 
Published: July 2019

Abstract
Backgruond

To compare weight-based versus standard dosing of intravenous (IV) tranexamic acid for blood loss and transfusion amount in total knee arthroplasty (TNA) without tourniquet.

Methods

A total of 99 patients who underwent TNA with the diagnosis of primary osteoarthritis were enrolled in this retrospective case-control study. Patients were divided into two groups according to the application of tranexamic acid. Group 1 (weight-based dosing): 10 mg/kg IV TA 30 min before the skin incision, and 10 mg/kg, at postoperative 30 min, and 3 h. Group 2 (standard dosing): 1 g of IV TA 30 min before skin incision, and 1 g at postoperative 30 min and 3 h. Hemoglobin levels, before, and 1, and 2 days after the operation, postoperative amount of decrease in hemoglobin levels, and amount of erythrocyte transfusion were recorded. Two scoring systems Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Society Score (KSS) were applied in the evaluation of TNA results preoperatively, and at 1., 3., 6., and 12. months, postoperatively.

Results

Both groups did not differ from each other by means of age (p=0.127), gender (p=0.528), BMI (p=0.782), operating sides (p=0.544), existing comorbidities (p=0.987), preoperative hemoglobin level (p=0.718), the amount of hemoglobin reduction (p=0.769), and the amount of erythrocytes transfused (p=0.913). In both study groups, hemoglobin levels in male patients dropped significantly more deeply than female patients. Also, in both study groups, hemoglobin levels were significantly lower in patients with comorbid illnesses. A statistically significant difference was not detected between Groups 1 and 2 in terms of pre- and postoperative WOMAC scores, KSS knee scores, and KSS function scores.

Conclusion

Our study showed that weight-based and standard dosing of IV tranexamic acid treatments were similar in efficacy and safety. Both treatments reduce blood loss and the need for transfusion. Also, there was no significant difference in terms of reliability between the two groups.
Changes in Bone Mineral Density Following Conventional Oral Phosphonate Treatment of Hypophosphatemic Osteomalacia: a case-control study
Authors: Guo Yue , Wu Xian-Ping , Zhou Ying-Hui , Tang Chen-Yi , Wang Min , Mo Zhao-Hui , Tang Jun , Shepherd John A , Ng Bennett K , Fan Bo , Feng Yun-Zhi , Zhou Hou-De 
Published: July 2019

Abstract
Background: There are limited clinical studies aimed at solving the problem of the efficiency of conventional treatment with oral phosphate and calcitriol in adults with hypophosphatemic osteomalacia (HO). In addition, there still had no good non-hazardous markers to evaluate the severity of bone loss of osteomalacia before and after treatment. Therefore, the purpose of this study was to assess the efficacy of conventional treatment with a self-blended phosphate supplementation and calcitriol on patients with HO and whether bone mineral density (BMD) can helpful for monitoring the efficacy.
Methods: 21 HO patients and 105 healthy controls were enrolled. HO patients with calcium and calcitriol were divided into three phosphate treatment groups: Patients in group A (n=3) received continuous phosphate supplementation, patients in group B (n=5) received intermittent phosphate supplementation and patients in group C (n=3) received no phosphate supplementation. 11 of 21 HO patients were recalled for detection of BMD of the lumbar spine (L1–L4), femoral neck, and total left hip three years after the treatment.
Results: The average initial serum phosphorus level of the patient group was approximately 50% lower than that of the control group. Lower BMD was significantly observed in the HO group than the control group at the lumbar spine and total hip. Continuous treatment with the phosphate supplement could increase BMD in the lumbar spine and total hip by 33.4–52.3% and the femoral neck increased by 43.2–79.3% compared with baseline, and the effect appears to be continued once treatment is discontinued.
Conclusions: These findings suggest that conventional therapy can improve bone mineral defects in patients with HO, especially in the femoral neck. Detection of BMD in HO patients is a good tool to assess the extent of bone defects and the therapeutic effect.
Reducing Barriers to Post-9/11 Veterans’ Use of Programs and Services as They Transition to Civilian Life
Authors: Morgan Nicole R. , Aronson Keith R. , Perkins Daniel F. , Bleser Julia A. , Davenport Katie , Vogt Dawne , Copeland Laurel A. , Finley Erin P. , Gilman Cynthia L. 
Published: July 2019

Abstract
Background - Numerous programs exist to support veterans in their transitions to civilian life. Programs are offered by a host of governmental and non-governmental stakeholders. Veterans report encountering many barriers to program participation. This was the first study to identify barrier reduction strategies offered by programs that post-9/11 veterans report using, determine which strategies veterans use and value, and to examine veteran characteristics that impact their odds of using programs that offer barrier reduction strategies.

Method - This study reflects findings from the first wave of data collection of The Veterans Metrics Initiative, a longitudinal study examining the military-to-civilian reintegration of post-9/11 veterans. Veterans were asked to indicate which programs they had used. The websites of these programs were coded for the barrier reduction components. Veterans also indicated which barrier reduction components they found most helpful in meeting their reintegration goals.

Results - Of 9,566 veterans who participated in Wave 1 data collection, 84% reported using a program that offered at least one barrier reduction component. Barrier reduction components included tangible supports (e.g., scholarships, cash), increased access to programs, decreased stigma, and encouraged motivation to change. Although only 4% of programs that were used by veterans focused on helping them obtain Veterans Administration benefits, nearly 60% of veterans reported that this component was helpful in reaching their goals. Access assistance to other resources and supports was also reported as a helpful barrier reduction component. For instance, approximately 20% of veterans nominated programs that offered transportation. The study also found evidence of a misalignment between the kinds of barrier reduction components veterans valued and those which programs offered. Veterans from the most junior enlisted ranks, who are at most risk, were less likely than those from other ranks to use barrier reduction components.

Conclusions – Despite the evidence that barrier reduction components enhance access to programs and contribute to program sustainability, many programs used by post-9/11 veterans do not offer them. There is also a misalignment between the barrier reduction strategies veterans value and the strategies offered by programs. Veteran serving organizations should increasingly implement barrier reduction strategies that veterans value.