Sharing data from clinical trials: the rationale for a controlled access approach.

The move towards increased transparency around clinical trials is welcome. Much focus has been on under-reporting of trials and access to individual patient data to allow independent verification of findings. There are many other good reasons for data sharing from clinical trials. We describe some key issues in data sharing, including the challenges of open access to data. These include issues in consent and disclosure; risks in identification, including self-identification; risks in distorting data to prevent self-identification; and risks in analysis. These risks have led us to develop a controlled access policy, which safeguards the rights of patients entered in our trials, guards the intellectual property rights of the original researchers who designed the trial and collected the data, provides a barrier against unnecessary duplication, and ensures that researchers have the necessary resources and skills to analyse the data

The Cultural and Commercial Value of Tulsi (Ocimum tenuiflorum L.): Multidisciplinary Approaches Focusing on Species Authentication

Tulsi (Holy basil, Ocimum tenuiflorum L., Lamiaceae), native to Asia, has become globalised as the cultural, cosmetic, and medicinal uses of the herb have been popularised. DNA barcoding, a molecular technique used to identify species based on short regions of DNA, can discriminate between different species and identify contaminants and adulterants. This study aimed to explore the values associated with Tulsi in the United Kingdom (UK) and authenticate samples using DNA barcoding. A mixed methods approach was used, incorporating social research (i.e., structured interviews) and DNA barcoding of Ocimum samples using the ITS and trnH-psbA barcode regions. Interviews revealed the cultural significance of Tulsi: including origins, knowledge exchange, religious connotations, and medicinal uses. With migration, sharing of plants and seeds has been seen as Tulsi plants are widely grown in South Asian (SA) households across the UK. Vouchered Ocimum specimens (n = 33) were obtained to create reference DNA barcodes which were not available in databases. A potential species substitution of O. gratissimum instead of O. tenuiflorum amongst SA participants was uncovered. Commercial samples (n = 47) were difficult to authenticate, potentially due to DNA degradation during manufacturing processes. This study highlights the cultural significance of Tulsi, despite a potential species substitution, the plant holds a prestigious place amongst SA families in the UK. DNA barcoding was a reliable way to authenticate Ocimum species

"Adulterated" Androstenedione: What FDA's Action against Andro Means for Industry

On March 11, 2004, the Food and Drug Administration (FDA) pronounced that dietary supplement products containing androstenedione were adulterated new dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA issued a press release, held a news conference, and sent warning letters to 23 companies that had manufactured, marketed or distributed the products containing androstenedione. In its warning letters, FDA threatened possible enforcement actions for noncompliance. The authors have looked at the warning letters, statutes, regulations, and media reports to analyze the legal grounds and standards upon which FDA acted against androstenedione and question the appropriateness of the action taken. They have also looked at the negative impact that FDA's lack of communication and cooperation with Industry is having upon the fitness nutrition industry and the marketing of dietary supplements containing new dietary ingredients. The authors also suggest what might be done to ameliorate this escalating problem including more cooperation between FDA and Industry and more research into the benefits and use of supplement products

Inspiratory muscle training reduces blood lactate concentration during volitional hyperpnoea

Although reduced blood lactate concentrations ([lac−]B) have been observed during whole-body exercise following inspiratory muscle training (IMT), it remains unknown whether the inspiratory muscles are the source of at least part of this reduction. To investigate this, we tested the hypothesis that IMT would attenuate the increase in [lac−]B caused by mimicking, at rest, the breathing pattern observed during high-intensity exercise. Twenty-two physically active males were matched for 85% maximal exercise minute ventilation (V˙Emax) and divided equally into an IMT or a control group. Prior to and following a 6 week intervention, participants performed 10 min of volitional hyperpnoea at the breathing pattern commensurate with 85% V˙Emax

Acute Respiratory Infections in the Middle-Belt Region of Nigeria

Background: ARI continues to be a leeding cause of death among children globally beyond the year 2000. Close 12 million children under the age of 5years die each year in the developing countries, mainly from preventable causes and approximately 2.28 million (19%) were due to acute respiratory infections (ARI). It therefore became necessary to assess the present status of the disease in Nigeria to mastermind workable plans for reducing the mortality and morbidity burden.Methods: A designed pro-forma was used to collect and collate information from mothers or direct care givers of children at both hospital and community levels relating to family background, home setting, anthropometry, clinical presentation of ARI, previous medications, investigations, complications and outcomes of illness.Results: A total of 163 children were recruited for the study. One hundred and six had moderate and severe form of ARI while 57 had mild form. The in-patients accounted for 15.2% of all the admission within the study period.All children were under 12 years of age with male preponderance. Fast breathing, Tarchypnoea, Cough and Fever were the leading ways of presentations. The immunization coverage of study population by various antigens in the EPI were poor. Majority of the hospital children had pre-consultation antibiotics while none of the children from the rural community had pre-recruitment antibiotics. Streptococcus pneumoniae and Staphylococcus aureus were the leading organisms isolated with good sensitivity to Quinolones, Gentamycin and Cephalosporins. Heart failure was the leading complications. Mortality was 12.3% among the hospitalized patient and none among the community children.Conclusion: It was concluded that ARI is still a major cause of morbidity and mortality among children with opportunity for burden reduction.Keywords: Acute Respiratory Infection, present outlook, burde