Fakultät III - Medien, Information und Design
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The present investigation was conducted to investigate the in-vitro activity of ethanolic extract of roots of Centaurea behens by using DPPH radical scavenging activity, nitric oxide radical scavenging activity, hydrogen peroxide radical scavenging activity, hydroxyl radical. Result suggests that the extract possess significant antioxidant activity as compared to the standard ascorbic acid and thus further in vivo investigation is required to evaluate the medicinal significance of the extract which can be used for assessing the possible therapeutic importance of the drug.
The drugs we use to treat any condition – from an innocuous cough to a life-threatening cancer – are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. In recent years there has been a clear shift in clinical trial sites from core developed countries like USA, European countries to developing countries like India, China, South American countries. This shift is related to challenges and opportunities like costs of trials, recruitment issues, and regulatory challenges in developed vs. developing countries. Developing countries and developed countries have their unique disease burden patterns based on various parameters like but not limited to age, health care facilities, health insurance, sanitary conditions, environmental issues, education, nutrition
and GDP. Previous studies have reported that many of the important global diseases are not much explored in clinical trials and many published clinical trials have very less international health relevance. This study was aimed at finding the correlation between disease burdens, number of clinical trials done and trial success rates. We compared 2005 - 2010 Global Burden of Disease data for Germany, India and number of clinical trials from clinicaltrials.gov database done in the same period. Our findings indicated that there was a good correlation between the disease burden and clinical trials for Germany in 2005 and 2010. For India in 2005 there was a moderate positive correlation, 2010 data showed the improvement in India in terms of match between disease burden and clinical trials. But careful observation of the data shows still a need for more trials on Communicable, maternal, neonatal and nutritional disorders.
Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide range of sectors that can benefit citizens. Nanomedicine is an application of nanotechnology in the areas of healthcare, disease diagnosis, treatment and prevention of disease. Nanomedicines pose problem of nanotoxicity related to factors like size, shape, specific surface area, surface morphology, and crystallinity. Currently, nanomedicines are regulated as medicinal products or as medical devices and there is no specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.
Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
Setting: USA, the EU, India and South Africa.
Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
Background: Foodstuff traders operating from warehouses (FTFW) are potentially exposed to dangerous rodenticides/pesticides that may have adverse effects on cardiopulmonary function. Methods: 50 consenting male foodstuff traders, comprising 15 traders (21–63 years) operating outside warehouses and 35 FTFW (20–64 years), were randomly recruited at Ogbete Market, Enugu, in a cross-sectional observational study of spirometric and electrocardiographic parameters. 17 FTFW (21–57 years) participated in focus group discussions. Qualitative and quantitative data were analysed thematically and with independent t-test and Pearson correlation coefficient at p < 0.05, respectively. Results: Most FTFW experienced respiratory symptoms, especially dry cough (97,1%) and wheezing (31.4%) with significant reductions in forced vital capacity (FVC) (t = -2.654; p = 0.011), forced expiratory volume in one second (FEV1) (t = -2.240; p = 0.030), maximum expiratory flow rate (FEF200-1200) (t = -1.148; p = -0.047), and forced end-expiratory flow (FEF25-75) (t = -1.11; p = 0.007). The maximum mid-expiratory flow (FEF25-75) was marginally decreased (p > 0.05) with a significantly prolonged (p < 0.05) QTc interval. Conclusion: Allergic response was evident in the FTFW. Significant decrease in FVC may negatively impact lung flow rates and explains the marginal decrease in FEF25-75, which implies a relative limitation in airflow of peripheral/distal airways and elastic recoil of the lungs. This is consistent with obstructive pulmonary disease; a significant decrease in FEF75-85/FEV1 supports this conclusion. Significant decrease in FEF200-1200 indicates abnormalities in the large airways/larynx just as significantly prolonged ventricular repolarization suggests cardiac arrhythmias.
Malnutrition, nutritional deficiency, or undernutrition is an imbalanced nutritional status resulting from insufficient intake of nutrients to meet normal physiologic requirements. Malnutrition in childhood has both short-term consequences and long-term consequences on mental and physical health as well as the overall health development of children. Of all regions in the world, the Asia and the Pacific region has achieved the fastest rate of economic growth. There is no evidence that this rapid economic growth translates into a decline in malnutrition of children in Asian countries such as India.
Malnutrition is the condition in which the body does not get the right amount of proteins, vitamins, or other nutrients.1 The global prevalence of malnutrition was reported as 13% in 2015.2 The subregion of South Asia is especially known as a critical area for severe wasted children aged <5 years.3 In India, 38.4% of children aged <3 years are stunted, and 46% are underweight.4 Malnutrition can lead to mortality as well as disabilities and long-term consequences such as cognitive disabilities, less economic productivity, or diseases.
The world health organization defines musculoskeletal disorder (MSD) as “a disorder of muscles, tendons, peripheral vascular system not directly resulting from an acute or instantaneous event.1 Work related MSDs are one of the most important occupational hazards.1 Among many other occupations, dentistry is a highly demanding profession that requires good visual acuity, hearing, depth perception, psychomotor skills, manual dexterity, and ability to maintain occupational postures over long periods.
The medical devices sector helps save lives by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment, and alleviation. Medical devices are classified into 1 of 3 categories in the order of increasing risk: Class I, Class II, and Class III.1 Medical devices are distinguished from drugs for regulatory purposes based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect.
Immunization is the most cost-effective intervention for infectious diseases, which are the major cause of morbidity and mortality worldwide. Vaccines not only protect the individual who is vaccinated but also reduce the burden of infectious vaccine-preventable diseases for the entire community.
1 Adult vaccination is very important given that >25% of mortality is due to infectious diseases.
2 There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India.