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"Miller, Lori"
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Biobanking: How Oncology Nurses Can Contribute to Its Use
by
Miller, Lori
,
Rosenzweig, Margaret
in
Biological specimens
,
Collections and collecting
,
Informed consent (Medical law)
2021
Biobanking is one of the most valuable tools in precision medicine. The ability of scientists to sequence tumors, blood, and normal tissue obtained from biorepositories has defined efficacious tumor targeting and a much better understanding of cancer pathology pathways. However, these biorepositories require a great deal of effort to establish and maintain. Oncology nurses are key in helping to bank tissue during routine procedures as well as complex surgeries. Nurses can obtain informed consent from patients and coordinate the banking of samples in a timely manner to ensure sample quality. Oncology nurses play an important role in informing patients of their biobanking options and connecting patients with the appropriate team for their biobanking needs.
Journal Article
Hidden heterogeneity: Uncovering patterns of adherence in microbicide trials for HIV prevention
by
Prieto Merino, David
,
Hayes, Richard
,
Baisley, Kathy
in
Anti-infective agents
,
Clinical trials
,
Complications and side effects
2022
Interpretation of clinical trial results testing vaginal microbicide gels for HIV prevention depends on participant adherence. Prior to the era of antiretrovirals, microbicide trials collected adherence data via self-report, and trials typically reported trial population adherence as overall averages in primary results manuscripts. This study first sought to determine if different patterns of adherence from three trials of vaginal microbicide gels could be identified, using self-reported data and if so, how those patterns compare across trials. The second objective was to explore which individual-level factors were associated with different adherence patterns. Data from the following three clinical trials of vaginal microbicides were used for this study: HIV Prevention Trials Network (HPTN) 035 testing PRO 2000 and Buffergel, the Microbicides Development Programme (MDP) 301 testing PRO 2000, and the Population Council's Carraguard study, testing Carraguard gel. Latent Class Analysis (LCA) was used to identify longitudinal patterns of adherence using self-reported data about gel use. Multinomial multivariable logistic regression was used to estimate relative risk-ratios for factors which were independently associated with different latent adherence trajectories within each trial, and compared across trials. Included in this analysis are 2,282 women from HPTN 035 (age 17-56 years), 6238 women from MDP 301 (age 16-75 years), and 6039 women from Carraguard (age 16-73 years). Using LCA, 3-4 different patterns of gel adherence were identified in each trial; these patterns were similar across the trials. Factors associated with adherence patterns were identified in all trials. Older age was associated with the adherence trajectory that consistently reported gel use in three trials. Participant-reported negative reaction of partners to the gel was associated with trajectories that reported less consistent adherence in two trials. A greater number of baseline-reported sex partners or sex acts was associated with trajectories which reported less consistent adherence in some trials. Trial site location was associated with membership of trajectories in all trials. LCA was able to identify patterns of microbicide gel adherence in clinical trials that used self-reported data. Key factors associated with patterns of adherence in this study were participant age, clinical trial site location, and partner reaction to the study gel. These findings, in particular, age and perceived partner reaction to the method, are consistent with results from other clinical trials and programmatic rollout of biomedical HIV prevention methods for women in Africa. This study contributes to the body of evidence that women need more support to navigate power dynamics within their relationships with men so that they can successfully use HIV prevention methods.
Journal Article
Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials
2021
Low adherence in vaginal microbicide clinical trials for HIV prevention has impeded interpretation of trial results and hindered evaluation of potentially efficacious HIV prevention gels. Understanding the underlying reasons why women join trials and their barriers to product use can support identification of ways to improve adherence and its reporting. Eight focus group discussion workshops were conducted with 46 former microbicide trial participants in Durban, South Africa and Mwanza, Tanzania. Participants provided feedback on why women join trials, the barriers to using study gel and reporting adherence accurately, and how clinical trial design can be improved to support better adherence and its reporting. Women join microbicide trials for a number of important reasons such as healthcare and financial reimbursement. Fear of adverse effects from the investigational product was the most important reason why participants reported not using the gel. The key reason for inaccurate reporting of gel use was fear of removal from the trial. Participants made concrete suggestions for improving microbicide trial design such as applicator use testing and real time feedback, improving education to participants about how trials answer their research questions, and improving transparency and clarity about study procedures. Participants also gave feedback on an innovative trial design with a non-randomised arm. Identifying HIV prevention products for women requires better understanding of the lives of women asked to join these trials, and application of that understanding to microbicide trial design. This study has demonstrated that participants and research teams can work collaboratively to design clinical trials that meet needs of both the research and of participants.
Journal Article
Hidden heterogeneity: Uncovering patterns of adherence in microbicide trials for HIV prevention
by
Prieto Merino, David
,
Hayes, Richard
,
Baisley, Kathy
in
Administration, Intravaginal
,
Adolescent
,
Adult
2022
Interpretation of clinical trial results testing vaginal microbicide gels for HIV prevention depends on participant adherence. Prior to the era of antiretrovirals, microbicide trials collected adherence data via self-report, and trials typically reported trial population adherence as overall averages in primary results manuscripts. This study first sought to determine if different patterns of adherence from three trials of vaginal microbicide gels could be identified, using self-reported data and if so, how those patterns compare across trials. The second objective was to explore which individual-level factors were associated with different adherence patterns.
Data from the following three clinical trials of vaginal microbicides were used for this study: HIV Prevention Trials Network (HPTN) 035 testing PRO 2000 and Buffergel, the Microbicides Development Programme (MDP) 301 testing PRO 2000, and the Population Council's Carraguard study, testing Carraguard gel. Latent Class Analysis (LCA) was used to identify longitudinal patterns of adherence using self-reported data about gel use. Multinomial multivariable logistic regression was used to estimate relative risk-ratios for factors which were independently associated with different latent adherence trajectories within each trial, and compared across trials.
Included in this analysis are 2,282 women from HPTN 035 (age 17-56 years), 6238 women from MDP 301 (age 16-75 years), and 6039 women from Carraguard (age 16-73 years). Using LCA, 3-4 different patterns of gel adherence were identified in each trial; these patterns were similar across the trials. Factors associated with adherence patterns were identified in all trials. Older age was associated with the adherence trajectory that consistently reported gel use in three trials. Participant-reported negative reaction of partners to the gel was associated with trajectories that reported less consistent adherence in two trials. A greater number of baseline-reported sex partners or sex acts was associated with trajectories which reported less consistent adherence in some trials. Trial site location was associated with membership of trajectories in all trials.
LCA was able to identify patterns of microbicide gel adherence in clinical trials that used self-reported data. Key factors associated with patterns of adherence in this study were participant age, clinical trial site location, and partner reaction to the study gel. These findings, in particular, age and perceived partner reaction to the method, are consistent with results from other clinical trials and programmatic rollout of biomedical HIV prevention methods for women in Africa. This study contributes to the body of evidence that women need more support to navigate power dynamics within their relationships with men so that they can successfully use HIV prevention methods.
Journal Article
ESR1 mutant breast cancers show elevated basal cytokeratins and immune activation
2022
Estrogen receptor alpha (ER/
ESR1
) is frequently mutated in endocrine resistant ER-positive (ER+) breast cancer and linked to ligand-independent growth and metastasis. Despite the distinct clinical features of
ESR1
mutations, their role in intrinsic subtype switching remains largely unknown. Here we find that
ESR1
mutant cells and clinical samples show a significant enrichment of basal subtype markers, and six basal cytokeratins (BCKs) are the most enriched genes. Induction of BCKs is independent of ER binding and instead associated with chromatin reprogramming centered around a progesterone receptor-orchestrated insulated neighborhood. BCK-high ER+ primary breast tumors exhibit a number of enriched immune pathways, shared with
ESR1
mutant tumors. S100A8 and S100A9 are among the most induced immune mediators and involve in tumor-stroma paracrine crosstalk inferred by single-cell RNA-seq from metastatic tumors. Collectively, these observations demonstrate that
ESR1
mutant tumors gain basal features associated with increased immune activation, encouraging additional studies of immune therapeutic vulnerabilities.
Mutations of
ESR1
, the gene encoding the estrogen receptor alpha, are associated with acquired resistance to therapy in luminalbreast cancer. Here the authors show that
ESR1
mutant tumors gain basal-like features with increased expression of basal cytokeratines and immune activation.
Journal Article
Connecting Future Environmental Trends and Assessments of Fish and Wildlife Resources of Concern: A Case Study of Big Pine Key, Florida
by
Miller, Lori A.
,
Harwell, Matthew C.
in
Case studies
,
Climate change
,
Endangered & extinct species
2022
Changes in hydrologic and climatic trends will influence the ecology of Florida, and climate scenarios agree that many areas of Florida are susceptible to sea-level rise impacts. The U.S. Fish and Wildlife Service’s Climate Change Action Program focuses on a framework to examine climate change effects on fish, wildlife, plants, and habitats of all three. To follow the program, this study examines how to incorporate current scientific knowledge about regional climate projections in U.S. Fish and Wildlife Service analyses. It provides climate change and sea-level rise projections based on 2017 projections, information on changes in tropical cyclones, temperatures, and precipitation. This study also examines future effects of sea-level rise on existing habitat from saltwater intrusion of the freshwater lens below Big Pine Key. Projections of future sea-water elevations will periodically be reached or exceeded well before 2040 from short-term, stochastic, and extreme events (e.g., king tides and storm surge), and will increasingly inundate the root zone before complete saltwater intrusion. Future trends were connected to 2017 stakeholder-driven conversations about adaptation strategies to develop a suite of actions for creating temporary or permanent freshwater resources. However, beyond 3 ft (0.9 m) of sea-level rise, there are few adaptation options available for the Florida Key deer beyond relocations outside of the Florida Keys. Overall, the approach of connecting future environmental trends to assessments of fish and wildlife resources of concern can be transferred to other situations. Additionally, this approach can be used to update these analyses, such as with the recent 2022 sea-level rise updates by the National Oceanic and Atmospheric Administration, released after this work was conducted.
Journal Article
Hope for OTHERS (Our Tissue Helping Enhance Research & Science): research results from the University of Pittsburgh rapid autopsy program for breast cancer
2025
Breast cancer affects 1/8 of women throughout their lifetimes, with over 90% of cancer deaths being caused by metastasis. However, metastasis poses unique challenges to research, as complex changes in the microenvironment in different metastatic sites and difficulty obtaining tissue for study hinder the ability to examine in depth the changes that occur during metastasis. Rapid autopsy programs thus fill a unique need in advancing metastasis research. Here, we describe our protocol and processes for establishing and improving the US-based Hope for OTHERS (Our Tissue Helping Enhance Research and Science) program for organ donation in metastatic breast cancer. As of August 2024, we consented 114 patients and performed 37 autopsies, from which we collected 551 unique metastatic frozen tumor samples, 1244 FFPE blocks, 90 longitudinal liquid biopsy samples and developed 14 patient-derived organoid and 8 patient-derived xenograft models. We report in-depth clinical and histopathological information and discuss extensive new research and novel findings in patient outcomes, metastatic phylogeny, and factors in successful living model development. Our results reveal key logistical and protocol improvements that are uniquely beneficial to certain programs based on identifiable features, such as working closely with patient advocates, methods to rescue RNA quality in cases where tissue quality may degrade due to time delays, as well as guidelines and future expansions of our program.
Journal Article
The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
by
El-Sheikh, Mohamed
,
Balogun, Eni
,
Beaumont, Danielle
in
Adult
,
Africa - epidemiology
,
Anemia - mortality
2020
Background
Post-partum haemorrhage (PPH) is a leading cause of maternal death worldwide. The WOMAN trial assessed the effects of tranexamic acid (TXA) on death and surgical morbidity in women with PPH. The trial recorded 483 maternal deaths. We report the circumstances of the women who died.
Methods
The WOMAN trial recruited 20,060 women with a clinical diagnosis of PPH after a vaginal birth or caesarean section. We randomly allocated women to receive TXA or placebo. When a woman died, we asked participating clinicians to report the cause of death and to provide a short narrative of the events surrounding the death. We collated and edited for clarity the narrative data.
Results
Case fatality rates were 3.0% in Africa and 1.7% in Asia. Nearly three quarters of deaths were within 3 h of delivery and 91% of these deaths were from bleeding. Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55–3.81) than those who delivered in hospital. Blood was often unavailable due to shortages or because relatives could not afford to buy it. Clinicians highlighted late presentation, maternal anaemia and poor infrastructure as key contributory factors.
Conclusions
Although TXA use reduces bleeding deaths by almost one third, mortality rates similar to those in high income countries will not be achieved without tackling late presentation, maternal anaemia, availability of blood for transfusion and poor infrastructure.
Journal Article
Static Aerated Composting of African Swine Fever Virus-Infected Swine Carcasses with Rice Hulls and Sawdust
by
Duc, Hoang Minh
,
Miller, Lori P.
,
Hutchinson, Mark
in
Aeration
,
African swine fever
,
African Swine Fever virus
2023
Identifying and ensuring the inactivation of the African Swine Fever virus in deadstock is a gap in the swine industry’s knowledge and response capabilities. The results of our study demonstrate that ASFv in deadstock was inactivated using static aerated composting as the carcass disposal method. Replicated compost piles with whole market hogs and two different carbon sources were constructed. In-situ bags containing ASFv-infected spleen tissue were placed alongside each of the carcasses and throughout the pile. The bags were extracted at days 0, 1, 3, 7, 14, 28, 56, and 144 for ASFv detection and isolation. Real-time PCR results showed that DNA of ASFv was detected in all samples tested on day 28. The virus concentration identified through virus isolation was found to be below the detection limit by day 3 in rice hulls and by day 7 in sawdust. Given the slope of the decay, near-zero concentration with 99.9% confidence occurred at 5.0 days in rice hulls and at 6.4 days in sawdust. Additionally, the result of virus isolation also showed that the virus in bone marrow samples collected at 28 days was inactivated.
Journal Article
African Americans' Access to Healthy Food Options in South Los Angeles Restaurants
by
Guinyard, Joyce Jones
,
REACH Coalition of African Americans Building A Legacy Of Health Project
,
Sloane, David C
in
Access
,
African Americans
,
African Americans - statistics & numerical data
2005
Objectives. We examined availability and food options at restaurants in less affluent (target area) and more affluent (comparison area) areas of Los Angeles County to compare residents’ access to healthy meals prepared and purchased away from home. We also considered environmental prompts that encourage the purchase of various foods. Methods. We designed an instrument to assess the availability, quality, and preparation of food in restaurants. We also assessed advertisements and promotions, cleanliness, and service for each restaurant. We assessed 659 restaurants: 348 in the target area and 311 in the comparison area. Results. The nutritional resource environment in our target area makes it challenging for residents to eat healthy away from home. Poorer neighborhoods with a higher proportion of African American residents have fewer healthy options available, both in food selections and in food preparation; restaurants in these neighborhoods heavily promote unhealthy food options to residents. Conclusions. Environment is important in understanding health status: support for the healthy lifestyle associated with lower risks for disease is difficult in poorer communities with a higher proportion of African American residents.
Journal Article