bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study
Authors: Liu Jian-Ping , Han Mei , Li Xin-Xue , Mu Yu-Jie , Lewith George , Wang Yu-Yi , Witt Claudia M , Yang Guo-Yan , Manheimer Eric , Snellingen Torkel , Berman Brian , Gluud Christian 
Published: July 2013

BackgroundClinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.ObjectiveTo describe the characteristics of TCM trials, estimate bias risk and outcome-reporting bias in clinical trials.Data sources and study selectionFifteen trial registries were searched from their inception to July 2012 to identify randomised trials on TCM including Chinese herbs, acupuncture and/or moxibustion, cupping, tuina, qigong, etc.Data extractionWe extracted data including TCM specialty and treated disease/conditions from the registries and searched for subsequent publications in PubMed and Chinese databases. We compared information in the registries of completed trials with any publications focusing on study design, sample size, randomisation, bias risk including reporting bias from the register protocol.Results1096 registered randomised trials were identified evaluating TCM, of which 505 were completed studies (46.1%). The most frequent conditions were pain (13.3%), musculoskeletal (11.7%), nervous (8.7%), digestive (7.1%), circulatory (6.5%), respiratory (6.3%), mental and behavioural disorders (6.2%) and cancer (6.0%). The trial register data identified parallel, phase II/III randomised trials with sample size estimations and blinding, but limited information about randomisation (sequence generation and allocation concealment). Comparing trial registration data of 115 completed trials (22.8%) with their subsequent 136 publications, inconsistencies were identified in one or more of the following: sample size (11%), outcome assessor blinding (37.5%), primary outcomes (29%) and safety (28%) reporting.ConclusionsIncreasing numbers of clinical trials investigating a variety of TCM interventions have been registered in international trial registries. The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos. However, selective outcome reporting is widespread and similar to conventional medicine and therefore study conclusions should be interpreted with caution.
Effects of enzyme replacement therapy for cardiac-type Fabry patients with a Chinese hotspot late-onset Fabry mutation (IVS4+919G>A)
Authors: Lin Hsiang-Yu , Liu Hao-Chuan , Huang Yu-Hsiu , Liao Hsuan-Chieh , Hsu Ting-Rong , Shen Chia-I , Li Shao-Tzu , Li Cheng-Fang , Lee Li-Hong , Lee Pi-Chang , Huang Chun-Kai , Chiang Chuan-Chi , Lin Ching-Yuang , Lin Shuan-Pei , Niu Dau-Ming 
Published: July 2013

ObjectiveCurrent studies of newborn screening for Fabry disease in Taiwan have revealed a remarkably high prevalence of cardiac-type Fabry disease with a Chinese hotspot late-onset Fabry mutation (IVS4+919G>A).DesignRetrospective cohort study.SettingTertiary medical centre.Participants21 patients with cardiac-type Fabry disease (15 men and 6 women) as well as 15 patients with classic Fabry disease (4 men and 11 women) treated with biweekly intravenous infusions of agalsidase β (1 mg/kg) or agalsidase α (0.2 mg/kg) for at least 6 months.Outcome measuresThese data were collected at the time before enzyme replacement therapy (ERT) began and followed up after ERT for at least 6 months, including patient demographics, medical history, parameter changes of cardiac status and renal functions, plasma globotriaosylsphingosine (lyso-Gb3) and Mainz Severity Score Index.ResultsAfter 6–39 months of ERT, plasma lyso-Gb3 was found to be reduced in 89% (17/19) and 93% (14/15) of patients with cardiac-type and classic Fabry disease, respectively, which indicated an improvement of disease severity. For patients with cardiac-type Fabry disease, echocardiography revealed the reduction or stabilisation of left ventricular mass index (LVMI), the thicknesses of intraventricular septum (IVS) and left posterior wall (LPW) in 83% (15/18), 83% (15/18) and 67% (12/18) of patients, respectively, as well as 77% (10/13), 73% (11/15) and 60% (9/15) for those with classic type. Most patients showed stable renal function after ERT. There were statistically significant improvements (p<0.05) between the data at baseline and those after ERT for values of plasma lyso-Gb3, LVMI, IVS, LPW and Mainz Severity Score Index. No severe clinical events were reported during the treatment.ConclusionsERT is beneficial and appears to be safe for Taiwanese patients with cardiac-type Fabry disease, as well as for those with the classic type.
A school-based education programme to reduce salt intake in children and their families (School-EduSalt): protocol of a cluster randomised controlled trial
Authors: He Feng J , Wu Yangfeng , Ma Jun , Feng Xiangxian , Wang Haijun , Zhang Jing , Lin Ching-Ping , Yuan Jianhui , Ma Yuan , Yang Yide , Yan Lijing L , Jan Stephen , Nowson Caryl , MacGregor Graham A 
Published: July 2013

IntroductionThe current salt intake is very high for children as well as adults in China. A reduction in salt intake is one of the most cost-effective measures to curb the rapidly growing disease burden attributed to blood pressure and cardiovascular disease in the Chinese population. A lower salt diet starting from childhood has the potential to prevent the development of such conditions. The School-EduSalt (School-basedEducation Programme to ReduceSalt) study aims to determine whether an education programme targeted at school children can lower salt intake in children and their families.Methods and analysisThe study is designed as a cluster randomised controlled trial. The location is Changzhi, Shanxi province in northern China. The study population will consist of 28 primary schools with 280 children aged ≈11 years and 560 adult family members. Children in the intervention group will be educated on how to reduce salt intake. They will then be empowered to deliver the salt reduction message home to their families. In particular, children need to persuade the person who does the cooking to reduce the amount of salt used during food preparations. The duration of the intervention is one school term (≈4.5 months). The primary outcome is the difference between the intervention and the control group in the change in 24 h urinary sodium and the secondary outcome is the difference between the intervention and control group in the change of blood pressure. An economic evaluation will be undertaken to assess cost-effectiveness.Ethics and disseminationThe study has been approved by The Queen Mary Research Ethics Committee (QMREC2012/81) and Peking University Health Science Centre IRB (IRB00001052-12072). Study findings will be disseminated widely through conference presentations and peer-reviewed publications.Protocol RegistrationProtocol Registered on ClinicalTrials.govNCT01821144.
Dual Targeting of Wild-Type and Mutant p53 by Small Molecule RITA Results in the Inhibition of N-Myc and Key Survival Oncogenes and Kills Neuroblastoma Cells In Vivo and In Vitro
Authors: Burmakin Mikhail , Shi Yao , Hedström Elisabeth , Kogner Per , Selivanova Galina 
Published: July 2013

Abstract
Purpose: Restoration of the p53 function in tumors is a promising therapeutic strategy due to the high potential of p53 as tumor suppressor and the fact that established tumors depend on p53 inactivation for their survival. Here, we addressed the question whether small molecule RITA can reactivate p53 in neuroblastoma and suppress the growth of neuroblastoma cells in vitro and in vivo.
Experimental Design: The ability of RITA to inhibit growth and to induce apoptosis was shown in seven neuroblastoma cell lines. Mechanistic studies were carried out to determine the p53 dependence and the molecular mechanism of RITA-induced apoptosis in neuroblastoma, using cell viability assays, RNAi silencing, co-immunoprecipitation, qPCR, and Western blotting analysis. In vivo experiments were conducted to study the effect of RITA on human neuroblastoma xenografts in mice.
Results: RITA induced p53-dependent apoptosis in a set of seven neuroblastoma cell lines, carrying wild-type or mutant p53; it activated p53 and triggered the expression of proapoptotic p53 target genes. Importantly, p53 activated by RITA inhibited several key oncogenes that are high-priority targets for pharmacologic anticancer strategies in neuroblastoma, including N-Myc, Aurora kinase, Mcl-1, Bcl-2, Wip-1, MDM2, and MDMX. Moreover, RITA had a strong antitumor effect in vivo.
Conclusions: Reactivation of wild-type and mutant p53 resulting in the induction of proapoptotic factors along with ablation of key oncogenes by compounds such as RITA may be a highly effective strategy to treat neuroblastoma. Clin Cancer Res; 19(18); 5092–103. ©2013 AACR.
Tumor-Specific T-cell Help Is Associated with Improved Survival in Melanoma
Authors: Woods Katherine , Cebon Jonathan 
Published: July 2013

Abstract
Despite success with immune checkpoint inhibitors, clinical benefit from cancer vaccines remains elusive. Combined targeting of melanoma-specific CD4+ and CD8+ T-lymphocyte epitopes was associated with improved survival compared with targeting either alone, or when a nonspecific helper epitope was used. We discuss the potential role of antigen-specific CD4 help. Clin Cancer Res; 19(15); 4021–3. ©2013 AACR.
AIM2, an IFN-Inducible Cytosolic DNA Sensor, in the Development of Benign Prostate Hyperplasia and Prostate Cancer
Authors: Ponomareva Larissa , Liu Hongzhu , Duan Xin , Dickerson Eric , Shen Hui , Panchanathan Ravichandran , Choubey Divaker 
Published: July 2013

Abstract
Close links have been noted between chronic inflammation of the prostate and the development of human prostatic diseases such as benign prostate hyperplasia (BPH) and prostate cancer. However, the molecular mechanisms that contribute to prostatic inflammation remain largely unexplored. Recent studies have indicated that the IFN-inducible AIM2 protein is a cytosolic DNA sensor in macrophages and keratinocytes. Upon sensing DNA, AIM2 recruits the adaptor ASC and pro-CASP1 to assemble the AIM2 inflammasome. Activation of the AIM2 inflammasome cleaves pro-interleukin (IL)-1β and pro-IL-18 and promotes the secretion of IL-1β and IL-18 proinflammatory cytokines. Given that human prostatic infections are associated with chronic inflammation, the development of BPH is associated with an accumulation of senescent cells with a proinflammatory phenotype, and the development of prostate cancer is associated with the loss of IFN signaling, the role of AIM2 in mediating the formation of prostatic diseases was investigated. It was determined that IFNs (α, β, or γ) induced AIM2 expression in human prostate epithelial cells and cytosolic DNA activated the AIM2 inflammasome. Steady-state levels of the AIM2 mRNA were higher in BPH than in normal prostate tissue. However, the levels of AIM2 mRNA were significantly lower in clinical tumor specimens. Accordingly, constitutive levels of AIM2 mRNA and protein were lower in a subset of prostate cancer cells as compared with BPH cells. Further, the cytosolic DNA activated the AIM2 inflammasome in the androgen receptor—negative PC3 prostate cancer cell line, suggesting that AIM2-mediated events are independent of androgen receptor status.
Implications: The AIM2 inflammasome has a fundamental role in the generation of human prostatic diseases. Mol Cancer Res; 11(10); 1193–202. ©2013 AACR.
Platelets and matrix metalloproteinases
Authors: Seizer Peter , May Andreas E. 
Published: July 2013

SummaryMatrix metalloproteinases (MMPs) and their inhibitors essentially contribute to a variety of pathophysiologies by modulating cell migration, tissue degradation and inflammation. Platelet-associated MMP activity appears to play a major role in these processes. First, platelets can concentrate leukocyte-derived MMP activity to sites of vascular injury by leukocyte recruitment. Second, platelets stimulate MMP production in e.g. leukocytes, endothelial cells, or tumour cells by direct receptor interaction or/and by paracrine pathways. Third, platelets synthesise and secrete a variety of MMPs including MMP-1, MMP-2, MMP-3, and MMP-14 (MT1-MMP), and potentially MMP-9 as well as the tissue inhibitors of metalloproteinase (TIMPs). This review focuses on platelet-derived and platelet-induced MMPs and their inhibitors.
Intervention for Recoarctation in the Single Ventricle Reconstruction Trial
Authors: Hill Kevin D. , Rhodes John F. , Aiyagari Ranjit , Baker G. Hamilton , Bergersen Lisa , Chai Paul J. , Fleming Gregory A. , Fudge J. Curt , Gillespie Matthew J. , Gray Robert G. , Hirsch Russel , Lee Kyong-Jin , Li Jennifer S. , Ohye Richard G. , Oster Matthew E. , Pasquali Sara K. , Pelech Andrew N. , Radtke Wolfgang A.K. , Takao Cheryl M. , Vincent Julie A. , Hornik Christoph P. 
Published: July 2013

Background—
Recoarctation after the Norwood procedure increases risk for mortality. The Single Ventricle Reconstruction (SVR) trial randomized subjects with a single right ventricle undergoing a Norwood procedure to a modified Blalock-Taussig shunt or a right ventricle–pulmonary artery shunt. We sought to determine the incidence of recoarctation, risk factors, and outcomes in the SVR trial.

Methods and Results—

Recoarctation was defined by intervention, either catheter based or surgical. Univariate analysis and multivariable Cox proportional hazard models were performed with adjustment for center. Of the 549 SVR subjects, 97 (18%) underwent 131 interventions (92 balloon aortoplasty, 39 surgical) for recoarctation at a median age of 4.9 months (range, 1.1–10.5 months). Intervention typically occurred at pre–stage II catheterization (n=71, 54%) or at stage II surgery (n=38, 29%). In multivariable analysis, recoarctation was associated with the shunt type in place at the end of the Norwood procedure (hazard ratio, 2.0 for right ventricle–pulmonary artery shunt versus modified Blalock-Taussig shunt;
P
=0.02), and Norwood discharge peak echo-Doppler arch gradient (hazard ratio, 1.07 per 1 mm Hg;
P
<0.01). Subjects with recoarctation demonstrated comorbidities at pre–stage II evaluation, including higher pulmonary arterial pressures (15.4±3.0 versus 14.5±3.5 mm Hg;
P
=0.05), higher pulmonary vascular resistance (2.6±1.6 versus 2.0±1.0 Wood units·m
2
;
P
=0.04), and increased echocardiographic volumes (end-diastolic volume, 126±39 versus 112±33 mL/BSA
1.3
, where BSA is body surface area;
P
=0.02). There was no difference in 12-month postrandomization transplantation-free survival between those with and without recoarctation (
P
=0.14).

Conclusions—
Recoarctation is common after Norwood and contributes to pre–stage II comorbidities. Although with intervention there is no associated increase in 1-year transplantation/mortality, further evaluation is warranted to evaluate the effects of associated morbidities.

Clinical Trial Registration—

URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00115934.
When Two Leviathans Clash: Free Movement of Persons in ECOWAS and the Ghana Investment Act of 1994
Authors: Kufuor Kofi Oteng 
Published: July 2013

Abstract
The Economic Community of West African States transformed itself into a supranational order in 1993. A supranational treaty entails a surrender of sovereignty by the members to the organs of the treaty. This has led to a trading dilemma in Ghana as its citizens are no longer protected from competition from national of parties to the new order.
Resurgence of the Traditional Justice System in Postcolonial Benin (Nigeria) Society
Authors: Idumwonyi Itohan Mercy , Ikhidero Solomon Ijeweimen 
Published: July 2013

Abstract
Rules and norms of behaviour are common features in human society. This is confirmed by human being’s desire for protection, fairness and mutual respect from fellow humans in their social groups. Recognized authorities whose sanctions are respected help to ensure fairness and mutual respect for each other. For the traditional Benin (African) society, the issue of law and justice is the joint concern of the deities, ancestors and the human members within the society. The aim of this paper, is to examine (i) the relevance of traditional justice system in postcolonial Benin (African) society; and (ii) the unwavering respect for traditional values which the Benin (African) people have maintained even in a postcolonial era; and argue that the continual preference for traditional methods of obtaining justice by the people of Benin (Africa) are not unconnected with the inherent limitations of the received English legal system within an African terrain. As insiders, we propose a harmonization of a ‘euro-afro-centric judicial system, for we believe that this would be beneficial and progressive for us as a people in quest for justice in a postcolonial Benin (African) society.
The ICC Addresses Non-Cooperation By States Parties: The Malawi Decision
Authors: Magliveras Konstantinos , Naldi Gino 
Published: July 2013

Abstract
This article examines the decision, issued by the Pre-Trial Chamber I of the ICC on 12 December 2011, concerning the failure of the Republic of Malawi to comply with the requests of co-operation that the ICC has extended to contracting parties in relation to the arrest and surrender of the indicted Sudanese President al-Bashir. Faced with blatant defiance by African States Parties, as well as a hostile African Union, the ICC has of late no longer restricted its reaction simply to informing the UN Security Council and the Assembly of States Parties of instances of non co-operation, but has also, for the first time, justified why it has found specific states to have violated their Rome Statute obligations by hosting al-Bashir on official visits to their territories.
An Appraisal of the Night Masquerade Festival and Discrimination against Women in Nigeria from an International Human Rights Law Perspective
Authors: Okeowo Demola 
Published: July 2013

Abstract
The Night Masquerade is one of several cultural practices that are well rooted within the Yoruba people in the south-western part of Nigeria. The masquerade is believed to be an adult male member of the society. This person traditionally walks about the town nakedly in the company of numerous other adult male members of the society, performing rituals and appeasing the gods. Generally, women are forbidden from viewing this masquerade and any woman who violates this rule shall be put to death to appease the gods. Over the years, this cultural practice has generated heated arguments and concern, especially from human rights activists and feminists. The paper will argue that any cultural practice that promotes discrimination on the basis of sex and that in fact leads to unnecessary restriction of movement and wanton loss of lives is repugnant to natural justice, equity and good conscience.
The International Law Principle of Permanent Sovereignty over Natural Resources as an Instrument for Development: The Case of Zimbabwean Diamonds
Authors: Chekera Yolanda T. , Nmehielle Vincent O. 
Published: July 2013

Abstract
Extensive research has shown that revenue from the exploitation of natural resources can sustain development. Conversely, development research literature has shown that many developing countries have failed to use the natural resources to improve and sustain good living for their citizens. In most cases, those in political offices have squandered the resources and benefits that have accrued from the country’s natural endowments. This article explores how the international law principle of permanent sovereignty over natural resources (PSNR) could be used as a vehicle for development, particularly looking at the case of Zimbabwean diamonds. While the principle could be an instrument for development, this article argues that legislation governing mining in Zimbabwe is not facilitative of a people-centred interpretation of the principle. Mining legislation vests the custodial right over the country’s mineral resources in the President. This creates an opportunity for abuse, as it limits the extent to which the people, as beneficiaries of the principle, can lay claim to the content of the principle. It also effectively limits any say the people may have on how revenue from the sale of diamonds is utilised, and how they would want to benefit from the resource. The article concludes that there is a need for legislative reform that speaks to development that is people-centred without which the majority of the people will keep sinking into the doldrums of extreme poverty, despite the country’s resource endowment. The hope is that the new Zimbabwean constitution will provide the impetus in this regard.
Extracorporeal life support for acute respiratory distress syndrome due to severe Legionella pneumonia
Authors: Bryner B , Miskulin J , Smith C , Cooley E , Grams R , Bartlett R , Annich G , Mychaliska GB 
Published: July 2013

Purpose: Legionella is a common cause of community-acquired pneumonia (CAP) and is second only to Pneumococcal pneumonia as a cause of severe CAP that requires treatment in an intensive care unit. We report a case series of patients with severe Legionella pneumonia who developed the acute respiratory distress syndrome (ARDS), failed to improve with mechanical ventilation alone and required extracorporeal life support (ECLS). Methods: We performed a retrospective study of all patients treated with ECLS at our institution for severe ARDS as a result of Legionella pneumonia from 1994 to 2006. Results: A total of twelve patients with a diagnosis of Legionella pneumonia were treated with veno-venous (VV) ECLS over this time period. Nine of these twelve (75%) were successfully treated and weaned off ECLS and 8 patients (67%) survived to hospital discharge. Two (13%) died of multisystem organ failure, one patient (8%) died from global hypoxic encephalopathy and one (8%) was weaned from ECLS, but ultimately died of liver failure. Renal failure requiring some form of continuous dialysis occurred in seven patients (58%) and the survival for this sub-set of patients was 43%. Conclusions: Extracorporeal life support for severe ARDS associated with Legionella pneumonia is an effective treatment option when mechanical ventilation fails, especially when introduced early in the course.