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Guinea pig scientists : bold self-experimenters in science and medicine :
Who are these \"guinea pig scientists\"? Searching for clues to some of science's and medicine's bigger (and sometimes stranger) questions, they are all the men and women who devoted their lives to help find the answers. Ages 10+
Book
A controlled human Schistosoma mansoni infection model to advance novel drugs, vaccines and diagnostics
Schistosomiasis treatment relies on the use of a single drug, praziquantel, which is insufficient to control transmission in highly endemic areas
1
. Novel medicines and vaccines are urgently needed
2
,
3
. An experimental human model for schistosomiasis could accelerate the development of these products. We performed a dose-escalating clinical safety trial in 17 volunteers with male
Schistosoma mansoni
cercariae, which do not produce eggs (clinicaltrials.gov
NCT02755324
), at the Leiden University Medical Center, the Netherlands. The primary endpoints were adverse events and infectivity. We found a dose-related increase in adverse events related to acute schistosomiasis syndrome, which occurred in 9 of 17 volunteers. Overall, 5 volunteers (all 3 of the high dose group and 2 of 11 of the medium dose group) reported severe adverse events. Worm-derived circulating anodic antigen, the biomarker of the primary infection endpoint, peaked in 82% of volunteers at 3–10 weeks following exposure. All volunteers showed IgM and IgG1 seroconversion and worm-specific cytokine production by CD4
+
T cells. All volunteers were cured with praziquantel provided at 12 weeks after exposure. Infection with 20
Schistosoma mansoni
cercariae led to severe adverse events in 18% of volunteers and high infection rates. This infection model paves the way for fast-track product development for treatment and prevention of schistosomiasis.
A new human challenge model of schistosomiasis, which affects more than 290 million people globally, will aid development of novel therapies and vaccines for this neglected tropical disease.
Journal Article
A randomized controlled experimental medicine study of ghrelin in value-based decision making
BACKGROUNDThe stomach-derived hormone ghrelin stimulates appetite, but the ghrelin receptor is also expressed in brain circuits involved in motivation and reward. We examined ghrelin effects on decision making beyond food or drug reward using monetary rewards.METHODSThirty participants (50% women and 50% men) underwent 2 fMRI scans while receiving i.v. ghrelin or saline in a randomized counterbalanced order.RESULTSStriatal representations of reward anticipation were unaffected by ghrelin, while activity during anticipation of losses was attenuated. Temporal discounting rates of monetary reward were lower overall in the ghrelin condition, an effect driven by women. Discounting rates were inversely correlated with neural activity in a large cluster within the left parietal lobule that included the angular gyrus. Activity in an overlapping cluster was related to behavioral choices and was suppressed by ghrelin.CONCLUSIONThis is, to our knowledge, the first human study to extend the understanding of ghrelin's significance beyond the canonical feeding domain or in relation to addictive substances. Contrary to our hypothesis, we found that ghrelin did not affect sensitivity to monetary reward anticipation, but rather resulted in attenuated loss aversion and lower discounting rates for these rewards. Ghrelin may cause a motivational shift toward caloric reward rather than globally promoting the value of reward.TRIAL REGISTRATIONEudraCT 2018-004829-82.FUNDINGSwedish Research Council (2013-07434), Marcus and Marianne Wallenberg foundation (2014.0187) and National Institute on Drug Abuse/National Institute on Alcohol Abuse and Alcoholism Intramural Research Program.
Journal Article
Public willingness to participate in personalized health research and biobanking: A large-scale Swiss survey
This paper reports survey findings on the Swiss public’s willingness, attitudes, and concerns regarding personalized health research participation by providing health information and biological material. The survey reached a sample of 15,106 Swiss residents, from which we received 5,156 responses (34.1% response rate). The majority of respondents were aware of research using human biological samples (71.0%) and held a positive opinion towards this type of research (62.4%). Of all respondents, 53.6% indicated that they would be willing to participate in a personalized health research project. Willingness to participate was higher in younger, higher educated, non-religious respondents with a background in the health sector. Respondents were more willing to provide ‘traditional’ types of health data, such as health questionnaires, blood or biological samples, as opposed to social media or app-related data. All respondents valued the return of individual research results, including risk for diseases for which no treatment is available. Our findings highlight that alongside general positive attitudes towards personalized health research using data and samples, respondents have concerns about data privacy and re-use. Concerns included potential discrimination, confidentiality breaches, and misuse of data for commercial or marketing purposes. The findings of this large-scale survey can inform Swiss research institutions and assist policymakers with adjusting practices and developing policies to better meet the needs and preferences of the public. Efforts in this direction could focus on research initiatives engaging in transparent communication, education, and engagement activities, to increase public understanding and insight into data sharing activities, and ultimately strengthen personalized health research efforts.
Journal Article
Improving Participant Recruitment in Clinical Trials: Comparative Analysis of Innovative Digital Platforms
Pharmaceutical product development relies on thorough and costly clinical trials. Participant recruitment and monitoring can be challenging. The incorporation of cutting-edge technologies such as blockchain and artificial intelligence has revolutionized clinical research (particularly in the recruitment stage), enhanced secure data storage and analysis, and facilitated participant monitoring while protecting their personal information.
This study aims to investigate the use of novel digital platforms and their features, such as e-recruitment, e-consent, and matching, aiming to optimize and expedite clinical research.
A review with a systematic approach was conducted encompassing literature from January 2000 to October 2024. The MEDLINE, ScienceDirect, Scopus, and Google Scholar databases were examined thoroughly using a customized search string. Inclusion criteria focused on digital platforms involving clinical trial recruitment phases that were in English and had international presence, scientific validation, regulatory approval, and no geographic limitations. Literature reviews and unvalidated digital platforms were excluded. The selected studies underwent meticulous screening by the research team, ensuring a thorough analysis of novel digital platforms and their use and features for clinical trials.
A total of 24 digital platforms were identified that supported clinical trial recruitment phases. In general, most of them (n=22, 80%) are headquartered and operating in the United States, providing a range of functionalities including electronic consent (n=14, 60% of the platforms), participant matching, and monitoring of patients' health status. These supplementary features enhance the overall effectiveness of the platforms in facilitating the recruitment process for clinical trials. The analysis and digital platform findings refer to a specific time frame when the investigation took place, and a notable surge was observed in the adoption of these novel digital tools, particularly following the COVID-19 outbreak.
This study underscores the vital role of the identified digital platforms in clinical trials, aiding in recruitment, enhancing patient engagement, accelerating procedures, and personalizing vital sign monitoring. Despite their impact, challenges in accessibility, compatibility, and transparency require careful consideration. Addressing these challenges is crucial for optimizing digital tool integration into clinical research, allowing researchers to harness the benefits while managing the associated risks effectively.
Journal Article
The Strange Case of Dr. Jekyll and Mr. Hyde
The most infamous of horror stories--a disturbing examination of man's capacity for evil One pitch-black London morning, a ghoulish little man tramples a young girl and continues heedlessly on his way.Caught by a passerby and returned to the scene of the crime, the man is forced to pay £100 in restitution.
eBook
National ethical guidelines for biomedical & health research involving human participants, 2017: A commentary
The Indian Council of Medical Research (ICMR) has been at the forefront in setting up the ethical guidance for the conduct of biomedical and health research in India. The latest version of National Guidelines for Biomedical and Health Research Involving Human Participants, 2017 was planned in order to provide a more detailed guidance to the existing topics in view of emerging ethical concerns and to add a number of newer areas in which guidance was lacking. The scope of the guidelines has been expanded to include socio-behavioural research related to health and research involving biological material and datasets. The guidelines have 12 sections which cover a wide range of topics and areas of research. The first six sections are more generic, applying to all types of biomedical and health research, while the next six sections are more subject specific. The guidelines have been revised in consultation with a large number of experts and stakeholders and went through an exhaustive process stretching over a period of two years in its drafting, review, consultation and finalisation. This commentary seeks to explain the process and key components of the Guidelines.
Journal Article
Immunological considerations for SARS-CoV-2 human challenge studies
The ethics and practicalities of controlled human infection with SARS-CoV-2 have been widely discussed. Potential risks are clear. The case in favour hinges upon whether these risks can be mitigated to an acceptable, very low, level and whether the studies will provide substantial benefits that could not readily be obtained by other means. Here, we discuss the immunological considerations relating to each side of this balance.In this Comment article, Sandy Douglas and Adrian Hill discuss the immunological considerations associated with a risk–benefit analysis for controlled human infection models of SARS-CoV-2.
Journal Article