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Articles 7021 - 7050 of 10523
Full-Text Articles in Medicine and Health Sciences
Effective Recruitment Strategies For A Sickle Cell Patient Registry Across Sites From The Sickle Cell Disease Implementation Consortium (Scdic), Rita V Masese, Taniya Varughese, Et Al.
Effective Recruitment Strategies For A Sickle Cell Patient Registry Across Sites From The Sickle Cell Disease Implementation Consortium (Scdic), Rita V Masese, Taniya Varughese, Et Al.
2020-Current year OA Pubs
Sickle cell disease (SCD) is a genetic disorder predominantly affecting people of African descent and is associated with significant morbidity and mortality. To improve SCD outcomes, the National Heart Lung and Blood Institute funded eight centers to participate in the SCD Implementation Consortium. Sites were required to each recruit 300 individuals with SCD, over 20 months. We aim to describe recruitment strategies and challenges encountered. Participants aged 15-45 years with confirmed diagnosis of SCD were eligible. Descriptive statistics were used to analyze the effectiveness of each recruitment strategy. A total of 2432 participants were recruited. Majority (95.3%) were African American. …
Progress Towards Antibiotic Use Targets In Eight High-Income Countries, Bryony Simmons, Koya Ariyoshi, Norio Ohmagari, Celine Pulcini, Benedikt Huttner, Sumanth Gandra, Giovanni Satta, Lorenzo Moja, Michael Sharland, Nicola Magrini, Marisa Miraldo, Graham Cooke
Progress Towards Antibiotic Use Targets In Eight High-Income Countries, Bryony Simmons, Koya Ariyoshi, Norio Ohmagari, Celine Pulcini, Benedikt Huttner, Sumanth Gandra, Giovanni Satta, Lorenzo Moja, Michael Sharland, Nicola Magrini, Marisa Miraldo, Graham Cooke
2020-Current year OA Pubs
OBJECTIVE: To compare antibiotic sales in eight high-income countries using the 2019 World Health Organization (WHO) Access, Watch and Reserve (AWaRe) classification and the target of 60% consumption of Access category antibiotics.
METHODS: We analysed data from a commercial database of sales of systemic antibiotics in France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland, and United States of America over the years 2013-2018. We classified antibiotics according to the 2019 AWaRe categories: Access, Watch, Reserve and Not Recommended. We measured antibiotic sales per capita in standard units (SU) per capita and calculated Access group …
Alliance Foundation Trial 09: A Randomized, Multicenter, Phase 2 Trial Evaluating Two Sequences Of Pembrolizumab And Standard Platinum-Based Chemotherapy In Patients With Metastatic Nsclc, Thomas A Hensing, Xiaofei Wang, Thomas E Stinchcombe, Junheng Gao, Michael V Knopp, Mark Watson, Arkadiusz Z Dudek, Stephen L Graziano, Jyoti D Patel, Bryan A Faller, Konstantin H Dragnev, David Kozono, Everett E Vokes
Alliance Foundation Trial 09: A Randomized, Multicenter, Phase 2 Trial Evaluating Two Sequences Of Pembrolizumab And Standard Platinum-Based Chemotherapy In Patients With Metastatic Nsclc, Thomas A Hensing, Xiaofei Wang, Thomas E Stinchcombe, Junheng Gao, Michael V Knopp, Mark Watson, Arkadiusz Z Dudek, Stephen L Graziano, Jyoti D Patel, Bryan A Faller, Konstantin H Dragnev, David Kozono, Everett E Vokes
2020-Current year OA Pubs
INTRODUCTION: The sequence of chemotherapy and pembrolizumab may affect antitumor immune response and efficacy of immunotherapy.
METHODS: This multicenter, randomized, phase 2 trial was designed to evaluate the efficacy of two sequences of chemotherapy and pembrolizumab in patients with stage 4 NSCLC. Both arms were considered investigational, and the study used a "pick a winner" design. The primary end point was objective response rate by independent radiologic review after eight cycles (24 wk). Patients were randomized 1:1 to arm A (chemotherapy for four cycles followed by pembrolizumab for four cycles) or arm B (pembrolizumab for four cycles followed by chemotherapy …
Examining The Patient And Caregiver Experience With Diazepam Nasal Spray For Seizure Clusters: Results From An Exit Survey Of A Phase 3, Open-Label, Repeat-Dose Safety Study, Patricia Penovich, James W Wheless, R Edward Hogan, Cynthia Guerra, David F Cook, Enrique Carrazana, Adrian L Rabinowicz
Examining The Patient And Caregiver Experience With Diazepam Nasal Spray For Seizure Clusters: Results From An Exit Survey Of A Phase 3, Open-Label, Repeat-Dose Safety Study, Patricia Penovich, James W Wheless, R Edward Hogan, Cynthia Guerra, David F Cook, Enrique Carrazana, Adrian L Rabinowicz
2020-Current year OA Pubs
BACKGROUND: Ideal rescue treatments for acute treatment of seizure clusters should be easy to administer, so it is important to assess user perceptions of these treatments. Diazepam nasal spray is designed to have a rapid, noninvasive, and socially acceptable route of administration. Patient and caregiver (including care partner) responses to surveys from a phase 3 safety study of diazepam nasal spray are reported.
METHODS: The study enrolled patients aged 6-65 years with seizure clusters. Surveys distributed to patients and caregivers at study end, completion, or discontinuation collected data on comfort using diazepam nasal spray outside the home, timing of administration …
Examining The Effects Of Hiv Self-Testing Compared To Standard Hiv Testing Services In The General Population: A Systematic Review And Meta-Analysis, Muhammad S Jamil, Ingrid Eshun-Wilson, Elvin Geng, Et Al.
Examining The Effects Of Hiv Self-Testing Compared To Standard Hiv Testing Services In The General Population: A Systematic Review And Meta-Analysis, Muhammad S Jamil, Ingrid Eshun-Wilson, Elvin Geng, Et Al.
2020-Current year OA Pubs
BACKGROUND: We updated a 2017 systematic review and compared the effects of HIV self-testing (HIVST) to standard HIV testing services to understand effective service delivery models among the general population.
METHODS: We included randomized controlled trials (RCTs) comparing testing outcomes with HIVST to standard testing in the general population and published between January 1, 2006 and June 4, 2019. Random effects meta-analysis was conducted and pooled risk ratios (RRs) were reported. The certainty of evidence was determined using the GRADE methodology.
FINDINGS: We identified 14 eligible RCTs, 13 of which were conducted in sub-Saharan Africa. Support provided to self-testers ranged …
Comparative Effectiveness Of Sodium-Glucose Cotransporter 2 Inhibitors Vs Sulfonylureas In Patients With Type 2 Diabetes, Yan Xie, Benjamin Bowe, Andrew K Gibson, Janet B Mcgill, Geetha Maddukuri, Ziyad Al-Aly
Comparative Effectiveness Of Sodium-Glucose Cotransporter 2 Inhibitors Vs Sulfonylureas In Patients With Type 2 Diabetes, Yan Xie, Benjamin Bowe, Andrew K Gibson, Janet B Mcgill, Geetha Maddukuri, Ziyad Al-Aly
2020-Current year OA Pubs
IMPORTANCE: In the treatment of type 2 diabetes, evidence of the comparative effectiveness of sodium-glucose cotransporter 2 (SGLT2) inhibitors vs sulfonylureas-the second most widely used antihyperglycemic class after metformin-is lacking.
OBJECTIVE: To evaluate the comparative effectiveness of SGLT2 inhibitors and sulfonylureas associated with the risk of all-cause mortality among patients with type 2 diabetes using metformin.
DESIGN, SETTING, AND PARTICIPANTS: A cohort study used data from the US Department of Veterans Affairs compared the use of SGLT2 inhibitors vs sulfonylureas in individuals receiving metformin for treatment of type 2 diabetes. A total of 23 870 individuals with new use of …
Extracorporeal Photopheresis To Attenuate Decline In Lung Function Due To Refractory Obstructive Allograft Dysfunction, Epi Study Group, Chadi A Hage, Suresh Vedantham, Mary Clare Derfler, Paul Commean, Ed Spitznagel, Jeff Atkinson, George Despotis, Et Al.
Extracorporeal Photopheresis To Attenuate Decline In Lung Function Due To Refractory Obstructive Allograft Dysfunction, Epi Study Group, Chadi A Hage, Suresh Vedantham, Mary Clare Derfler, Paul Commean, Ed Spitznagel, Jeff Atkinson, George Despotis, Et Al.
2020-Current year OA Pubs
BACKGROUND: This study was designed to prospectively evaluate the efficacy of extracorporeal photopheresis (ECP) to attenuate the rate of decline of FEV
STUDY DESIGN AND METHODS: Subjects from 10 lung transplant centres were assigned to ECP treatment or to observation based on spirometric criteria, with potential crossover for those under observation. The primary endpoint of this study was to assess response to ECP (i.e., greater than a 50% decrease in the rate of FEV
RESULTS: Of 44 enrolled subjects, 31 were assigned to ECP treatment while 13 were initially assigned to observation on a non-random basis using specific spirometric inclusion …
Changes In The Gut Microbiome Influence The Hypoglycemic Effect Of Metformin Through The Altered Metabolism Of Branched-Chain And Nonessential Amino Acids, Yujin Lee, Andrew Hyoungjin Kim, Eunwoo Kim, Seunghwan Lee, Kyung-Sang Yu, In-Jin Jang, Jae-Yong Chung, Joo-Youn Cho
Changes In The Gut Microbiome Influence The Hypoglycemic Effect Of Metformin Through The Altered Metabolism Of Branched-Chain And Nonessential Amino Acids, Yujin Lee, Andrew Hyoungjin Kim, Eunwoo Kim, Seunghwan Lee, Kyung-Sang Yu, In-Jin Jang, Jae-Yong Chung, Joo-Youn Cho
2020-Current year OA Pubs
AIMS: Although metformin has been reported to affect the gut microbiome, the mechanism has not been fully determined. We explained the potential underlying mechanisms of metformin through a multiomics approach.
METHODS: An open-label and single-arm clinical trial involving 20 healthy Korean was conducted. Serum glucose and insulin concentrations were measured, and stool samples were collected to analyze the microbiome. Untargeted metabolomic profiling of plasma, urine, and stool samples was performed by GC-TOF-MS. Network analysis was applied to infer the mechanism of the hypoglycemic effect of metformin.
RESULTS: The relative abundances of Escherichia, Romboutsia, Intestinibacter, and Clostridium were changed by metformin …
Tumor-On-Chip Modeling Of Organ-Specific Cancer And Metastasis, Nuala Del Piccolo, Venktesh S Shirure, Ye Bi, S Peter Goedegebuure, Sepideh Gholami, Christopher C W Hughes, Ryan C Fields, Steven C George
Tumor-On-Chip Modeling Of Organ-Specific Cancer And Metastasis, Nuala Del Piccolo, Venktesh S Shirure, Ye Bi, S Peter Goedegebuure, Sepideh Gholami, Christopher C W Hughes, Ryan C Fields, Steven C George
2020-Current year OA Pubs
Every year, cancer claims millions of lives around the globe. Unfortunately, model systems that accurately mimic human oncology - a requirement for the development of more effective therapies for these patients - remain elusive. Tumor development is an organ-specific process that involves modification of existing tissue features, recruitment of other cell types, and eventual metastasis to distant organs. Recently, tissue engineered microfluidic devices have emerged as a powerful in vitro tool to model human physiology and pathology with organ-specificity. These organ-on-chip platforms consist of cells cultured in 3D hydrogels and offer precise control over geometry, biological components, and physiochemical properties. …
Distinct Progression Patterns Across Parkinson Disease Clinical Subtypes, Peter S Myers, Joshua J Jackson, Amber K Clover, Christina N Lessov-Schlaggar, Erin R Foster, Baijayanta Maiti, Joel S Perlmutter, Meghan C Campbell
Distinct Progression Patterns Across Parkinson Disease Clinical Subtypes, Peter S Myers, Joshua J Jackson, Amber K Clover, Christina N Lessov-Schlaggar, Erin R Foster, Baijayanta Maiti, Joel S Perlmutter, Meghan C Campbell
Open Access Publications
OBJECTIVE: To examine specific symptom progression patterns and possible disease staging in Parkinson disease clinical subtypes.
METHODS: We recently identified Parkinson disease clinical subtypes based on comprehensive behavioral evaluations, "Motor Only," "Psychiatric & Motor," and "Cognitive & Motor," which differed in dementia and mortality rates. Parkinson disease participants ("Motor Only": n = 61, "Psychiatric & Motor": n = 17, "Cognitive & Motor": n = 70) and controls (n = 55) completed longitudinal, comprehensive motor, cognitive, and psychiatric evaluations (average follow-up = 4.6 years). Hierarchical linear modeling examined group differences in symptom progression. A three-way interaction among time, group, and symptom …
Race And Ethnicity Representation In Clinical Trials: Findings From A Literature Review Of Phase I Oncology Trials, D Ross Camidge, Haeseong Park, Karen E Smoyer, Ira Jacobs, Lauren J Lee, Zemfira Askerova, Justin Mcginnis, Yousef Zakharia
Race And Ethnicity Representation In Clinical Trials: Findings From A Literature Review Of Phase I Oncology Trials, D Ross Camidge, Haeseong Park, Karen E Smoyer, Ira Jacobs, Lauren J Lee, Zemfira Askerova, Justin Mcginnis, Yousef Zakharia
2020-Current year OA Pubs
No abstract provided.
Phase Ii Study Of Durvalumab Plus Tremelimumab As Therapy For Patients With Previously Treated Anti-Pd-1/Pd-L1 Resistant Stage Iv Squamous Cell Lung Cancer (Lung-Map Substudy S1400f, Nct03373760), Natasha B Leighl, Jeffrey D Bradley, Et Al
Phase Ii Study Of Durvalumab Plus Tremelimumab As Therapy For Patients With Previously Treated Anti-Pd-1/Pd-L1 Resistant Stage Iv Squamous Cell Lung Cancer (Lung-Map Substudy S1400f, Nct03373760), Natasha B Leighl, Jeffrey D Bradley, Et Al
2020-Current year OA Pubs
INTRODUCTION: S1400F is a non-match substudy of Lung Cancer Master Protocol (Lung-MAP) evaluating the immunotherapy combination of durvalumab and tremelimumab to overcome resistance to anti-programmed death ligand 1 (PD-(L)1) therapy in patients with advanced squamous lung carcinoma (sq non-small-cell lung cancer (NSCLC)).
METHODS: Patients with previously treated sqNSCLC with disease progression after anti-PD-(L)1 monotherapy, who did not qualify for any active molecularly targeted Lung-MAP substudies, were eligible. Patients received tremelimumab 75 mg plus durvalumab 1500 mg once every 28 days for four cycles then durvalumab alone every 28 days until disease progression. The primary endpoint was the objective response rate …
Integrated Analysis Of A Phase 2 Study Of Cemiplimab In Advanced Cutaneous Squamous Cell Carcinoma: Extended Follow-Up Of Outcomes And Quality Of Life Analysis, Danny Rischin, Leonel Hernandez-Aya, Et Al
Integrated Analysis Of A Phase 2 Study Of Cemiplimab In Advanced Cutaneous Squamous Cell Carcinoma: Extended Follow-Up Of Outcomes And Quality Of Life Analysis, Danny Rischin, Leonel Hernandez-Aya, Et Al
2020-Current year OA Pubs
BACKGROUND: To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL).
METHODS: Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 …
Long-Term Evaluation Of A Course On Evidence-Based Public Health In The U.S. And Europe, Rebekah R Jacob, Carol A Brownson, Anjali D Deshpande, Amy A Eyler, Kathleen N Gillespie, Jennie Hefelfinger, Paul C Erwin, Marti Macchi, Ross C Brownson
Long-Term Evaluation Of A Course On Evidence-Based Public Health In The U.S. And Europe, Rebekah R Jacob, Carol A Brownson, Anjali D Deshpande, Amy A Eyler, Kathleen N Gillespie, Jennie Hefelfinger, Paul C Erwin, Marti Macchi, Ross C Brownson
2020-Current year OA Pubs
The evidence-based public health course equips public health professionals with skills and tools for applying evidence-based frameworks and processes in public health practice. To date, training has included participants from all the 50 U.S. states, 2 U.S. territories, and multiple other countries besides the U.S. This study pooled follow-up efforts (5 surveys, with 723 course participants, 2005-2019) to explore the benefits, application, and barriers to applying the evidence-based public health course content. All analyses were completed in 2020. The most common benefits (reported by >80% of all participants) were identifying ways to apply knowledge in their work, acquiring new knowledge, …
Standardizing Definitions Of Hematopoietic Recovery, Graft Rejection, Graft Failure, Poor Graft Function, And Donor Chimerism In Allogeneic Hematopoietic Cell Transplantation: A Report On Behalf Of The American Society For Transplantation And Cellular Therapy, Mohamed A Kharfan-Dabaja, Iskra Pusic, Shalini Shenoy, Et Al.
Standardizing Definitions Of Hematopoietic Recovery, Graft Rejection, Graft Failure, Poor Graft Function, And Donor Chimerism In Allogeneic Hematopoietic Cell Transplantation: A Report On Behalf Of The American Society For Transplantation And Cellular Therapy, Mohamed A Kharfan-Dabaja, Iskra Pusic, Shalini Shenoy, Et Al.
2020-Current year OA Pubs
Allogeneic hematopoietic cell transplantation (allo-HCT) is potentially curative for certain hematologic malignancies and nonmalignant diseases. The field of allo-HCT has witnessed significant advances, including broadening indications for transplantation, availability of alternative donor sources, less toxic preparative regimens, new cell manipulation techniques, and novel GVHD prevention methods, all of which have expanded the applicability of the procedure. These advances have led to clinical practice conundrums when applying traditional definitions of hematopoietic recovery, graft rejection, graft failure, poor graft function, and donor chimerism, because these may vary based on donor type, cell source, cell dose, primary disease, graft-versus-host disease (GVHD) prophylaxis, and …
Il-7 Expands Lymphocyte Populations And Enhances Immune Responses To Sipuleucel-T In Patients With Metastatic Castration-Resistant Prostate Cancer (Mcrpc), Russell K Pachynski, Chihiro Morishima, Et Al
Il-7 Expands Lymphocyte Populations And Enhances Immune Responses To Sipuleucel-T In Patients With Metastatic Castration-Resistant Prostate Cancer (Mcrpc), Russell K Pachynski, Chihiro Morishima, Et Al
2020-Current year OA Pubs
BACKGROUND: Sipuleucel-T (sip-T) is a Food and Drug Administration (FDA)-approved autologous cellular immunotherapy for metastatic castration-resistant prostate cancer (mCRPC). We hypothesized that combining sip-T with interleukin (IL)-7, a homeostatic cytokine that enhances both B and T cell development and proliferation, would augment and prolong antigen-specific immune responses against both PA2024 (the immunogen for sip-T) and prostatic acid phosphatase (PAP).
METHODS: Fifty-four patients with mCRPC treated with sip-T were subsequently enrolled and randomized 1:1 into observation (n=26) or IL-7 (n=28) arms of a phase II clinical trial (NCT01881867). Recombinant human (rh) IL-7 (CYT107) was given weekly×4. Immune responses were evaluated using …
Use Of Convalescent Plasma In Covid-19 Patients With Immunosuppression, Jonathon W Senefeld, Jeffrey P Henderson, Et Al.
Use Of Convalescent Plasma In Covid-19 Patients With Immunosuppression, Jonathon W Senefeld, Jeffrey P Henderson, Et Al.
2020-Current year OA Pubs
In the absence of effective countermeasures, human convalescent plasma has been widely used to treat severe acute respiratory syndrome coronavirus 2, the causative agent of novel coronavirus disease 19 (COVID-19), including among patients with innate or acquired immunosuppression. However, the association between COVID-19-associated mortality in patients with immunosuppression and therapeutic use of convalescent plasma is unknown. We review 75 reports, including one large matched-control registry study of 143 COVID-19 patients with hematological malignancies, and 51 case reports and 23 case series representing 238 COVID-19 patients with immunosuppression. We review clinical features and treatment protocols of COVID-19 patients with immunosuppression after …
Association Of Low Center Performance Evaluations And Pediatric Heart Transplant Center Behavior In The United States, Shahnawaz Amdani, Gerard Boyle, Joseph Rossano, Janet Scheel, Marc Richmond, Susana Arrigain, Jesse D Schold
Association Of Low Center Performance Evaluations And Pediatric Heart Transplant Center Behavior In The United States, Shahnawaz Amdani, Gerard Boyle, Joseph Rossano, Janet Scheel, Marc Richmond, Susana Arrigain, Jesse D Schold
2020-Current year OA Pubs
BACKGROUND: To date, no study has evaluated the effects of low center performance evaluations (CPE) on pediatric heart transplant center behavior. We sought to assess the impact of low CPE flags on pediatric heart transplant center listing and transplant volumes and center recipient and donor characteristics.
METHODS: We included centers performing at least 10 pediatric (age <18 years) transplants during the Scientific Registry of Transplant Recipients reporting period January 2009-June 2011 and evaluated consecutive biannual program specific reports until the last reporting period January 2016-June 2018. We evaluated changes in center behavior at following time points: a year before flagging, a year and two years after the flag; and at last reporting period.
RESULTS: During our study period, 24 pediatric centers were non-flagged and 6 were flagged. Compared to non-flagged centers, there was a decline in candidate listings in flagged centers at the last reporting period (mean increase of 5.5 ± 12.4 listings vs"?> mean decrease of …
18>De-Identification Procedures For Magnetic Resonance Images And The Impact On Structural Brain Measures At Different Ages, Elizabeth E L Buimer, Hugo G Schnack, Yaron Caspi, Neeltje E M Van Haren, Mikhail Milchenko, Pascal Pas, Alzheimer's Disease Neuroimaging Initiative, Hilleke E Hulshoff Pol, Rachel M Brouwer
De-Identification Procedures For Magnetic Resonance Images And The Impact On Structural Brain Measures At Different Ages, Elizabeth E L Buimer, Hugo G Schnack, Yaron Caspi, Neeltje E M Van Haren, Mikhail Milchenko, Pascal Pas, Alzheimer's Disease Neuroimaging Initiative, Hilleke E Hulshoff Pol, Rachel M Brouwer
2020-Current year OA Pubs
Surface rendering of MRI brain scans may lead to identification of the participant through facial characteristics. In this study, we evaluate three methods that overwrite voxels containing privacy-sensitive information: Face Masking, FreeSurfer defacing, and FSL defacing. We included structural T1-weighted MRI scans of children, young adults and older adults. For the young adults, test-retest data were included with a 1-week interval. The effects of the de-identification methods were quantified using different statistics to capture random variation and systematic noise in measures obtained through the FreeSurfer processing pipeline. Face Masking and FSL defacing impacted brain voxels in some scans especially in …
Scissor-Type Knife Improves The Safety Of Endoscopic Submucosal Dissection (Esd) Among Endoscopists Without Experience In Esd: A Randomized Ex Vivo Study, Kavel Visrodia, Tarek Sawas, Liam Zakko, Juan Reyes Genere, Cadman Leggett, Lori Lutzke, Kenneth K. Wang
Scissor-Type Knife Improves The Safety Of Endoscopic Submucosal Dissection (Esd) Among Endoscopists Without Experience In Esd: A Randomized Ex Vivo Study, Kavel Visrodia, Tarek Sawas, Liam Zakko, Juan Reyes Genere, Cadman Leggett, Lori Lutzke, Kenneth K. Wang
2020-Current year OA Pubs
No abstract provided.
Efficacy Of Neratinib Plus Capecitabine In The Subgroup Of Patients With Central Nervous System Involvement From The Nala Trial, Sara A Hurvitz, Ron Bose, Et Al
Efficacy Of Neratinib Plus Capecitabine In The Subgroup Of Patients With Central Nervous System Involvement From The Nala Trial, Sara A Hurvitz, Ron Bose, Et Al
2020-Current year OA Pubs
BACKGROUND: Neratinib has efficacy in central nervous system (CNS) metastases from HER2-positive metastatic breast cancer (MBC). We report outcomes among patients with CNS metastases at baseline from the phase III NALA trial of neratinib plus capecitabine (N + C) versus lapatinib plus capecitabine (L + C).
MATERIALS AND METHODS: NALA was a randomized, active-controlled trial in patients who received two or more previous HER2-directed regimens for HER2-positive MBC. Patients with asymptomatic/stable brain metastases (treated or untreated) were eligible. Patients were assigned to N + C (neratinib 240 mg per day, capecitabine 750 mg/m
RESULTS: Of 621 patients enrolled, 101 (16.3%) …
Variants In Prkar1b Cause A Neurodevelopmental Disorder With Autism Spectrum Disorder, Apraxia, And Insensitivity To Pain, Felix Marbach, Marisa V Andrews, Dorothy K Grange, Et Al.
Variants In Prkar1b Cause A Neurodevelopmental Disorder With Autism Spectrum Disorder, Apraxia, And Insensitivity To Pain, Felix Marbach, Marisa V Andrews, Dorothy K Grange, Et Al.
2020-Current year OA Pubs
PURPOSE: We characterize the clinical and molecular phenotypes of six unrelated individuals with intellectual disability and autism spectrum disorder who carry heterozygous missense variants of the PRKAR1B gene, which encodes the R1β subunit of the cyclic AMP-dependent protein kinase A (PKA).
METHODS: Variants of PRKAR1B were identified by single- or trio-exome analysis. We contacted the families and physicians of the six individuals to collect phenotypic information, performed in vitro analyses of the identified PRKAR1B-variants, and investigated PRKAR1B expression during embryonic development.
RESULTS: Recent studies of large patient cohorts with neurodevelopmental disorders found significant enrichment of de novo missense variants in …
Developmental Differences In Affective Representation Between Prefrontal And Subcortical Structures, William J Mitchell, Lindsey J Tepfer, Nicole M Henninger, Susan B Perlman, Vishnu P Murty, Chelsea Helion
Developmental Differences In Affective Representation Between Prefrontal And Subcortical Structures, William J Mitchell, Lindsey J Tepfer, Nicole M Henninger, Susan B Perlman, Vishnu P Murty, Chelsea Helion
2020-Current year OA Pubs
Developmental studies have identified differences in prefrontal and subcortical affective structures between children and adults, which correspond with observed cognitive and behavioral maturations from relatively simplistic emotional experiences and expressions to more nuanced, complex ones. However, developmental changes in the neural representation of emotions have not yet been well explored. It stands to reason that adults and children may demonstrate observable differences in the representation of affect within key neurological structures implicated in affective cognition. Forty-five participants (25 children; 20 adults) passively viewed positive, negative, and neutral clips from popular films while undergoing functional magnetic resonance imaging (fMRI). Using representational …
Effects Of A Dvd-Delivered Randomized Controlled Physical Activity Intervention On Functional Health In Cancer Survivors, Elizabeth A Salerno, Neha P Gothe, Jason Fanning, Lindsay L Peterson, Graham A Colditz, Edward Mcauley
Effects Of A Dvd-Delivered Randomized Controlled Physical Activity Intervention On Functional Health In Cancer Survivors, Elizabeth A Salerno, Neha P Gothe, Jason Fanning, Lindsay L Peterson, Graham A Colditz, Edward Mcauley
2020-Current year OA Pubs
BACKGROUND: Supervised physical activity interventions improve functional health during cancer survivorship, but remain costly and inaccessible for many. We previously reported on the benefits of a DVD-delivered physical activity program (FlexToBa™) in older adults. This is a secondary analysis of the intervention effects among cancer survivors in the original sample.
METHODS: Low active, older adults who self-reported a history of cancer (N = 46; M time since diagnosis = 10.7 ± 9.4 years) participated in a 6-month, home-based physical activity intervention. Participants were randomized to either the DVD-delivered physical activity program focused on flexibility, toning, and balance (FlexToBa™; n = …
Altered Neuronal Physiology, Development, And Function Associated With A Common Chromosome 15 Duplication Involving Chrna7, Kesavan Meganathan, Ramachandran Prakasam, Dustin Baldridge, Paul Gontarz, Bo Zhang, Fumihiko Urano, Azad Bonni, Susan E Maloney, Tychele N Turner, James E Huettner, John N Constantino, Kristen L Kroll
Altered Neuronal Physiology, Development, And Function Associated With A Common Chromosome 15 Duplication Involving Chrna7, Kesavan Meganathan, Ramachandran Prakasam, Dustin Baldridge, Paul Gontarz, Bo Zhang, Fumihiko Urano, Azad Bonni, Susan E Maloney, Tychele N Turner, James E Huettner, John N Constantino, Kristen L Kroll
2020-Current year OA Pubs
BACKGROUND: Copy number variants (CNVs) linked to genes involved in nervous system development or function are often associated with neuropsychiatric disease. While CNVs involving deletions generally cause severe and highly penetrant patient phenotypes, CNVs leading to duplications tend instead to exhibit widely variable and less penetrant phenotypic expressivity among affected individuals. CNVs located on chromosome 15q13.3 affecting the alpha-7 nicotinic acetylcholine receptor subunit (CHRNA7) gene contribute to multiple neuropsychiatric disorders with highly variable penetrance. However, the basis of such differential penetrance remains uncharacterized. Here, we generated induced pluripotent stem cell (iPSC) models from first-degree relatives with a 15q13.3 duplication and …
Statistical Analysis Of Two Arm Randomized Pre-Post Designs With One Post-Treatment Measurement, Fei Wan
Statistical Analysis Of Two Arm Randomized Pre-Post Designs With One Post-Treatment Measurement, Fei Wan
2020-Current year OA Pubs
BACKGROUND: Randomized pre-post designs, with outcomes measured at baseline and after treatment, have been commonly used to compare the clinical effectiveness of two competing treatments. There are vast, but often conflicting, amount of information in current literature about the best analytic methods for pre-post designs. It is challenging for applied researchers to make an informed choice.
METHODS: We discuss six methods commonly used in literature: one way analysis of variance ("ANOVA"), analysis of covariance main effect and interaction models on the post-treatment score ("ANCOVAI" and "ANCOVAII"), ANOVA on the change score between the baseline and post-treatment scores ("ANOVA-Change"), repeated measures …
The Effect Of Virtual Mindfulness-Based Interventions On Sleep Quality: A Systematic Review Of Randomized Controlled Trials, Amanda Jiang, Michael Rosario, Sara Stahl, Jessica M Gill, Heather L Rusch
The Effect Of Virtual Mindfulness-Based Interventions On Sleep Quality: A Systematic Review Of Randomized Controlled Trials, Amanda Jiang, Michael Rosario, Sara Stahl, Jessica M Gill, Heather L Rusch
2020-Current year OA Pubs
PURPOSE OF REVIEW: We summarized peer-reviewed literature investigating the effect of virtual mindfulness-based interventions (MBIs) on sleep quality. We aimed to examine the following three questions: (1) do virtual MBIs improve sleep quality when compared with control groups; (2) does the effect persist long-term; and (3) is the virtual delivery method equally feasible compared to the in-person delivery method?
RECENT FINDINGS: Findings suggest that virtual MBIs are equivalent to evidence-based treatments, and to a limited extent, more effective than non-specific active controls at reducing some aspects of sleep disturbance. Overall, virtual MBIs are more effective at improving sleep quality than …
The Informed Road Map To Prevention Of Alzheimer Disease: A Call To Arms, Eric Mcdade, Jorge J Llibre-Guerra, David M Holtzman, John C Morris, Randall J Bateman
The Informed Road Map To Prevention Of Alzheimer Disease: A Call To Arms, Eric Mcdade, Jorge J Llibre-Guerra, David M Holtzman, John C Morris, Randall J Bateman
2020-Current year OA Pubs
Alzheimer disease (AD) prevention trials hold the promise to delay or prevent cognitive decline and dementia onset by intervening before significant neuronal damage occurs. In recent years, the first AD prevention trials have launched and are yielding important findings on the biology of targeting asymptomatic AD pathology. However, there are limitations that impact the design of these prevention trials, including the translation of animal models that recapitulate key stages and multiple pathological aspects of the human disease, missing target validation in asymptomatic disease, uncertain causality of the association of pathophysiologic changes with cognitive and clinical symptoms, and limited biomarker validation …
Exploring Perceptions Of Healthcare Technologies Enabled By Artificial Intelligence: An Online, Scenario-Based Survey, Alison L Antes, Sara Burrous, Bryan A Sisk, Matthew J Schuelke, Jason D Keune, James M Dubois
Exploring Perceptions Of Healthcare Technologies Enabled By Artificial Intelligence: An Online, Scenario-Based Survey, Alison L Antes, Sara Burrous, Bryan A Sisk, Matthew J Schuelke, Jason D Keune, James M Dubois
2020-Current year OA Pubs
BACKGROUND: Healthcare is expected to increasingly integrate technologies enabled by artificial intelligence (AI) into patient care. Understanding perceptions of these tools is essential to successful development and adoption. This exploratory study gauged participants' level of openness, concern, and perceived benefit associated with AI-driven healthcare technologies. We also explored socio-demographic, health-related, and psychosocial correlates of these perceptions.
METHODS: We developed a measure depicting six AI-driven technologies that either diagnose, predict, or suggest treatment. We administered the measure via an online survey to adults (N = 936) in the United States using MTurk, a crowdsourcing platform. Participants indicated their level of openness …
A Single Intranasal Or Intramuscular Immunization With Chimpanzee Adenovirus-Vectored Sars-Cov-2 Vaccine Protects Against Pneumonia In Hamsters, Traci L. Bricker, Tamarand L. Darling, Ahmed O. Hassan, Houda H. Harastani, Allison Soung, Xiaoping Jiang, Ya-Nan Dai, Haiyan Zhao, Lucas J. Adams, Michael J. Holtzman, Adam L. Bailey, James Brett Case, Daved H. Fremont, Robyn Klein, Michael S. Diamond, Adrianus C. M. Boon
A Single Intranasal Or Intramuscular Immunization With Chimpanzee Adenovirus-Vectored Sars-Cov-2 Vaccine Protects Against Pneumonia In Hamsters, Traci L. Bricker, Tamarand L. Darling, Ahmed O. Hassan, Houda H. Harastani, Allison Soung, Xiaoping Jiang, Ya-Nan Dai, Haiyan Zhao, Lucas J. Adams, Michael J. Holtzman, Adam L. Bailey, James Brett Case, Daved H. Fremont, Robyn Klein, Michael S. Diamond, Adrianus C. M. Boon
2020-Current year OA Pubs
The development of an effective vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiologic agent of coronavirus disease 2019 (COVID-19), is a global priority. Here, we compare the protective capacity of intranasal and intramuscular delivery of a chimpanzee adenovirus-vectored vaccine encoding a prefusion stabilized spike protein (chimpanzee adenovirus [ChAd]-SARS-CoV-2-S) in Golden Syrian hamsters. Although immunization with ChAd-SARS-CoV-2-S induces robust spike-protein-specific antibodies capable of neutralizing the virus, antibody levels in serum are higher in hamsters vaccinated by an intranasal compared to intramuscular route. Accordingly, against challenge with SARS-CoV-2, ChAd-SARS-CoV-2-S-immunized hamsters are protected against less weight loss and have reduced …