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2020

Clinical trials

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Full-Text Articles in Medicine and Health Sciences

Action Items For Breast Cancer Awareness Month, Deanna J. Attai Oct 2020

Action Items For Breast Cancer Awareness Month, Deanna J. Attai

Journal of Patient-Centered Research and Reviews

This special issue introduction provides a brief history of Breast Cancer Awareness Month and focuses on patient populations often omitted from annual marketing campaigns. The importance of research is emphasized as a means to improve the outcomes of people with metastatic breast cancer and male breast cancer as well as to address health care inequities related to breast cancer diagnosis and treatment.


Gains Across Who Dimensions Of Function After Robot-Based Therapy In Stroke Subjects, Jennifer Wu, Lucy Dodakian, Jill See, Erin Burke Quinlan, Lisa Meng, Jeby Abraham, Ellen C. Wong, Vu Le, Alison Mckenzie, Steven C. Cramer Oct 2020

Gains Across Who Dimensions Of Function After Robot-Based Therapy In Stroke Subjects, Jennifer Wu, Lucy Dodakian, Jill See, Erin Burke Quinlan, Lisa Meng, Jeby Abraham, Ellen C. Wong, Vu Le, Alison Mckenzie, Steven C. Cramer

Physical Therapy Faculty Articles and Research

Background

Studies examining the effects of therapeutic interventions after stroke often focus on changes in loss of body function/structure (impairment). However, improvements in activities limitations and participation restriction are often higher patient priorities, and the relationship that these measures have with loss of body function/structure is unclear.

Objective

This study measured gains across WHO International Classification of Function (ICF) dimensions and examined their interrelationships.

Methods

Subjects were recruited 11 to 26 weeks after hemiparetic stroke. Over a 3-week period, subjects received 12 sessions of intensive robot-based therapy targeting the distal arm. Each subject was assessed at baseline and at 1 …


Clinical Application Of Oncolytic Viruses: A Systematic Review, Mary Cook, Aman Chauhan Oct 2020

Clinical Application Of Oncolytic Viruses: A Systematic Review, Mary Cook, Aman Chauhan

Internal Medicine Faculty Publications

Leveraging the immune system to thwart cancer is not a novel strategy and has been explored via cancer vaccines and use of immunomodulators like interferons. However, it was not until the introduction of immune checkpoint inhibitors that we realized the true potential of immunotherapy in combating cancer. Oncolytic viruses are one such immunotherapeutic tool that is currently being explored in cancer therapeutics. We present the most comprehensive systematic review of all oncolytic viruses in Phase 1, 2, and 3 clinical trials published to date. We performed a systematic review of all published clinical trials indexed in PubMed that utilized oncolytic …


Proceedings Of The 2019 Canadian Inflammatory Myopathy Study Symposium: Clinical Trial Readiness In Myositis., Valérie Leclair, Océane Landon-Cardinal, Rohit Aggarwal, Nick Bansback, Craig Campbell, Brian M Feldman, Martin Jarry, Suzan Mcnamara, Barbara White, Marie Hudson Oct 2020

Proceedings Of The 2019 Canadian Inflammatory Myopathy Study Symposium: Clinical Trial Readiness In Myositis., Valérie Leclair, Océane Landon-Cardinal, Rohit Aggarwal, Nick Bansback, Craig Campbell, Brian M Feldman, Martin Jarry, Suzan Mcnamara, Barbara White, Marie Hudson

Paediatrics Publications

The Canadian Inflammatory Myopathy Study (CIMS) is a multicenter prospective cohort recruiting in 8 centers across Canada. One of the aims of CIMS is to conduct and participate in clinical trials in autoimmune inflammatory myopathies (AIM). Conducting clinical trials in rare diseases such as AIM presents challenges. During this symposium, experts in the field presented different solutions to successfully conduct clinical trials in AIM, including the importance of collaboration and careful trial design, as well as training and mentoring of young investigators.


Stem Cell Therapy For Dilated Cardiomyopathy: Systematic Review Of The Existing Data And Ongoing Trials, Abdalla M. Kamal, Ehsan S. Sarhan, Waleed A. Ibrahim Sep 2020

Stem Cell Therapy For Dilated Cardiomyopathy: Systematic Review Of The Existing Data And Ongoing Trials, Abdalla M. Kamal, Ehsan S. Sarhan, Waleed A. Ibrahim

Menoufia Medical Journal

Objectives The aim of this review is to preview recent advances in clinical applications of stem cell therapy in nonischemic dilated cardiomyopathy (DCM). Data sources PubMed and OVID Library were searched. There was no restriction on the publication year. Articles in English language only were reviewed. Clinicaltrials.gov was searched also to find ongoing and unpublished trials. Study selection Studies that included adult DCM patients injected with any type of stem cells were selected. Data extraction: in this review, data from published studies were manually extracted and summarized. Data synthesis In this review, the data revealed that stem cell therapy can …


Priority Outcomes In Critically Ill Children: A Patient And Parent Perspective, Nora Fayed, Saoirse Cameron, Douglas Fraser Md, Phd, Frcpc, Jill I Cameron, Samah Al-Harbi, Racquel Simpson, Maha Wakim, Lily Chiu, Karen Choong Sep 2020

Priority Outcomes In Critically Ill Children: A Patient And Parent Perspective, Nora Fayed, Saoirse Cameron, Douglas Fraser Md, Phd, Frcpc, Jill I Cameron, Samah Al-Harbi, Racquel Simpson, Maha Wakim, Lily Chiu, Karen Choong

Paediatrics Publications

BACKGROUND: Outcomes in pediatric critical care research are typically selected by the researcher.

OBJECTIVES: (1) To identify outcomes prioritized by patients and their families following a critical illness and (2) to determine the overlap between patient-centered and researcher-selected study outcomes.

METHODS: An exploratory descriptive qualitative study nested within a longitudinal cohort study conducted in 2 pediatric intensive care units (PICUs). Participants were purposively sampled from the primary cohort to ensure adequate demographic representation. Qualitative descriptive approaches based on naturalistic observation were used to collect data and analyze results. Data were coded by using the International Classification of Functioning, Disability, and …


A Measure To Determine Acceptable Workload For Increasing Operational Efficiencies For The Conduct Of Clinical Trials, Lester Rey Lledo Rn, Crnp, Dnp, Catherine Johnson Fnp, Pnp, Phd, Anne Chew Phd, Joan Gilmore Bs, Karen Dengel Bsn, Jane Anderson Ms Aug 2020

A Measure To Determine Acceptable Workload For Increasing Operational Efficiencies For The Conduct Of Clinical Trials, Lester Rey Lledo Rn, Crnp, Dnp, Catherine Johnson Fnp, Pnp, Phd, Anne Chew Phd, Joan Gilmore Bs, Karen Dengel Bsn, Jane Anderson Ms

Doctor of Nursing Practice (DNP) Manuscripts

As the demands for the conduct of clinical trials rise, it becomes increasingly important to establish a quantitative means of estimating the appropriate staffing resource to coordinate trial related activities. There has been a limited amount of research conducted to evaluate methods or tools to measure workload in the clinical trial setting. A literature search revealed a gap in the literature about tools used to measure workload and its impact on clinical trial performance and job satisfaction. The aim of this pilot project was to test the Ontario Protocol Assessment Level (OPAL) complexity rating tool in generating quantitative measurements of …


Biomarker Application For Precision Medicine In Stroke, Alexis N. Simpkins, Miroslaw Janowski, Helieh S. Oz, Jill Roberts, Gregory Bix, Sylvain Doré, Ann M. Stowe Aug 2020

Biomarker Application For Precision Medicine In Stroke, Alexis N. Simpkins, Miroslaw Janowski, Helieh S. Oz, Jill Roberts, Gregory Bix, Sylvain Doré, Ann M. Stowe

Neurosurgery Faculty Publications

Stroke remains one of the leading causes of long-term disability and mortality despite recent advances in acute thrombolytic therapies. In fact, the global lifetime risk of stroke in adults over the age of 25 is approximately 25%, with 24.9 million cases of ischemic stroke and 18.7 million cases of hemorrhagic stroke reported in 2015. One of the main challenges in developing effective new acute therapeutics and enhanced long-term interventions for stroke recovery is the heterogeneity of stroke, including etiology, comorbidities, and lifestyle factors that uniquely affect each individual stroke survivor. In this comprehensive review, we propose that future biomarker studies …


Financial Conflicts Of Interest Change After A High-Impact Clinical Trial Publication In Oncology, Craig L. Cambridge, Emily Stern Gatof, Glen J. Weiss, Roger B. Davis Jul 2020

Financial Conflicts Of Interest Change After A High-Impact Clinical Trial Publication In Oncology, Craig L. Cambridge, Emily Stern Gatof, Glen J. Weiss, Roger B. Davis

Journal of Patient-Centered Research and Reviews

Purpose: Because financial conflicts of interest (FCOIs) may potentially influence patient care, hospital drug formularies, and treatment guidelines, it is important that these are disclosed. The purpose of this observational study was to quantify the changes in FCOI among U.S.-based academic authors in industry-sponsored oncology trials after a high-impact publication.

Methods: A list of all U.S.-based academic authors (authors) of industry-sponsored solid tumor clinical trials published between August 1, 2014, and December 31, 2015, in 6 high-impact journals (New England Journal of Medicine, Nature, Science, Lancet Oncology, Journal of Clinical Oncology, and Cancer Discovery) was assembled. Studies were limited to …


Engaging Patients For Clinical Trials In Africa: Patient-Centered Approaches, Miriam Mutebi, Dicey Scroggins, Virgil Simons, Naomi Ohene Oti, Nazik Hammad Jul 2020

Engaging Patients For Clinical Trials In Africa: Patient-Centered Approaches, Miriam Mutebi, Dicey Scroggins, Virgil Simons, Naomi Ohene Oti, Nazik Hammad

General Surgery, East Africa

Clinical trials in oncology are an emergent field in sub-Saharan Africa. There is a long history of clinical trials in high-income countries (HICs), with increasing attempts to develop patient-centric approaches and to evaluate patient-centered outcomes. The challenge remains as to how these trends could be adopted in low-resource settings and adapted to best fit the different health ecosystems that coexist on the African continent. Models that evaluate patient-related outcomes and measures and that are used in HICs must be modified, adopted, and adapted to suit the diverse populations and the low-resource settings in most of the continent. Patient engagement in …


Formative Research To Design A Culturally-Appropriate Cancer Clinical Trial Education Program To Increase Participation Of African American And Latino Communities, Jennifer Cunningham-Erves, Claudia Barajas, Tilicia Mayo-Gamble, Caree R. Mcafee, Pamela Hull, Maureen Sanderson, Juan Canedo, Katina Beard, Consuelo H. Wilkins Jun 2020

Formative Research To Design A Culturally-Appropriate Cancer Clinical Trial Education Program To Increase Participation Of African American And Latino Communities, Jennifer Cunningham-Erves, Claudia Barajas, Tilicia Mayo-Gamble, Caree R. Mcafee, Pamela Hull, Maureen Sanderson, Juan Canedo, Katina Beard, Consuelo H. Wilkins

Department of Health Policy and Community Health Faculty Publications

Background: Addressing knowledge deficiencies about cancer clinical trials and biospecimen donation can potentially improve participation among racial and ethnic minorities. This paper describes the formative research process used to design a culturally-appropriate cancer clinical trials education program for African American and Latino communities. We characterized community member feedback and its integration into the program.

Methods: We incorporated three engagement approaches into the formative research process to iteratively develop the program: including community-based organization (CBO) leaders as research team members, conducting focus groups and cognitive interviews with community members as reviewers/consultants, and interacting with two community advisory groups. An …


Factors Affecting Clinical Research Enrollment Among Individuals With Alzheimer's Disease And Related Dementias, Nicole Grace Bouranis Jun 2020

Factors Affecting Clinical Research Enrollment Among Individuals With Alzheimer's Disease And Related Dementias, Nicole Grace Bouranis

Dissertations and Theses

The need to increase ADRD research participation has become more pressing as the prevalence of ADRD increases. Nearly 70,000 Oregonians and 7 million people in the United States live with ADRD, and this number is expected to increase by 200% by 2050 without identification of an intervention to halt its increase. Developing mechanisms for effective care and treatment depends on implementing research with numerous participants. Historically, ADRD research programs have had difficulty recruiting and enrolling individuals into studies for a variety of reasons. Given low recruitment rates, the interest in researching and evaluating effective strategies to recruit specifically for ADRD …


Novel Inference Methods For Generalized Linear Models Using Shrinkage Priors And Data Augmentation., Arinjita Bhattacharyya May 2020

Novel Inference Methods For Generalized Linear Models Using Shrinkage Priors And Data Augmentation., Arinjita Bhattacharyya

Electronic Theses and Dissertations

Generalized linear models have broad applications in biostatistics and sociology. In a regression setup, the main target is to find a relevant set of predictors out of a large collection of covariates. Sparsity is the assumption that only a few of these covariates in a regression setup have a meaningful correlation with an outcome variate of interest. Sparsity is incorporated by regularizing the irrelevant slopes towards zero without changing the relevant predictors and keeping the resulting inferences intact. Frequentist variable selection and sparsity are addressed by popular techniques like Lasso, Elastic Net. Bayesian penalized regression can tackle the curse of …


The Inflammatory Bowel Disease Questionnaire In Randomized Controlled Trials Of Treatment For Ulcerative Colitis: Systematic Review And Meta-Analysis, Aaron Yarlas, Stephen Maher, Martha Bayliss, Andrew Lovley, Joseph C. Cappelleri, Andrew G. Bushmakin, Marco D. Dibonaventura Apr 2020

The Inflammatory Bowel Disease Questionnaire In Randomized Controlled Trials Of Treatment For Ulcerative Colitis: Systematic Review And Meta-Analysis, Aaron Yarlas, Stephen Maher, Martha Bayliss, Andrew Lovley, Joseph C. Cappelleri, Andrew G. Bushmakin, Marco D. Dibonaventura

Journal of Patient-Centered Research and Reviews

Purpose: The 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32) is the most frequently used instrument to capture disease-specific quality of life in randomized clinical trials for ulcerative colitis. This review and meta-analysis provides the first synthesis of evidence regarding the sensitivity of IBDQ-32 total and domain scores to treatment efficacy.

Methods: A systematic literature search and risk-of-bias assessment yielded 14 articles that were included in the primary analysis. Treatments were categorized as efficacious if they met the primary efficacy endpoint (which was not the IBDQ-32); otherwise they were categorized as non-efficacious. A continuous measure of treatment efficacy was calculated for …


Selinexor Hyperactivates Akt And Induces Its Nuclear Accumulation, Erin Lawrence Apr 2020

Selinexor Hyperactivates Akt And Induces Its Nuclear Accumulation, Erin Lawrence

Honors Scholars Collaborative Projects

Selinexor is currently being used in several clinical trials for cancer and has shown anti-cancer effects in combination with other chemotherapies. Clinical trials evaluating the use of selinexor in the treatment of triple negative breast cancer are limited, but in vitro studies show promising results in its ability to kill triple negative breast cancer cells. The mechanism by which this occurs, however, is not understood. The goal of this research was to determine the mechanism by which selinexor kills BT- 549 triple negative breast cancer cells.


2020-03-30 A Message From Chancellor Roth, Paul B. Roth Mar 2020

2020-03-30 A Message From Chancellor Roth, Paul B. Roth

HSC Messages from the Chancellor

No abstract provided.


Systematic Reviews That Include Only Published Data May Overestimate The Effectiveness Of Analgesic Medicines For Low Back Pain: A Systematic Review And Meta-Analysis, Matthew K. Bagg, Edel O'Hagan, Pauline Zahara, Benedict Wand, Markus Hubscher, G. Lorimer Moseley, James H. Mcauley Jan 2020

Systematic Reviews That Include Only Published Data May Overestimate The Effectiveness Of Analgesic Medicines For Low Back Pain: A Systematic Review And Meta-Analysis, Matthew K. Bagg, Edel O'Hagan, Pauline Zahara, Benedict Wand, Markus Hubscher, G. Lorimer Moseley, James H. Mcauley

Physiotherapy Papers and Journal Articles

Objective: Systematic reviews of analgesics for low back pain generally include published data only. Obtaining data from unpublished trials is potentially important because they may impact effect sizes in meta-analyses. We determined whether including unpublished data from trial registries changes the effect sizes in meta-analyses of analgesics for low back pain.

Study Design and Setting: Trial registries were searched for unpublished data that conformed to the inclusion criteria of n = 5 individual source systematic reviews. We reproduced the meta-analyses using data available from the original reviews and then reran the same analyses with the addition of new unpublished data. …


Mesenchymal Stem Cell Therapy Alleviates The Neuroinflammation Associated With Acquired Brain Injury, Brooke Bonsack, Sydney Corey, Alex Shear, Matt Heyck, Blaise Cozene, Nadia Sadanandan, Henry Zhang, Bella Gonzales-Portillo, Michael Sheyner, Cesar V. Borlongan Jan 2020

Mesenchymal Stem Cell Therapy Alleviates The Neuroinflammation Associated With Acquired Brain Injury, Brooke Bonsack, Sydney Corey, Alex Shear, Matt Heyck, Blaise Cozene, Nadia Sadanandan, Henry Zhang, Bella Gonzales-Portillo, Michael Sheyner, Cesar V. Borlongan

Neurosurgery and Brain Repair Faculty Publications

Ischemic stroke and traumatic brain injury (TBI) comprise two particularly prevalent and costly examples of acquired brain injury (ABI). Following stroke or TBI, primary cell death and secondary cell death closely model disease progression and worsen outcomes. Mounting evidence indicates that long-term neuroinflammation extensively exacerbates the secondary deterioration of brain structure and function. Due to their immunomodulatory and regenerative properties, mesenchymal stem cell transplants have emerged as a promising approach to treating this facet of stroke and TBI pathology. In this review, we summarize the classification of cell death in ABI and discuss the prominent role of inflammation. We then …


Potential Of Mesenchymal Stem Cells Alone, Or In Combination, To Treat Traumatic Brain Injury, Alison E. Willing, Mahasweta Das, Mark Howell, Shyam S. Mohapatra, Subhra Mohapatra Jan 2020

Potential Of Mesenchymal Stem Cells Alone, Or In Combination, To Treat Traumatic Brain Injury, Alison E. Willing, Mahasweta Das, Mark Howell, Shyam S. Mohapatra, Subhra Mohapatra

Neurosurgery and Brain Repair Faculty Publications

Traumatic brain injury (TBI) causes death and disability in the United States and around the world. The traumatic insult causes the mechanical injury of the brain and primary cellular death. While a comprehensive pathological mechanism of TBI is still lacking, the focus of the TBI research is concentrated on understanding the pathophysiology and developing suitable therapeutic approaches. Given the complexities in pathophysiology involving interconnected immunologic, inflammatory, and neurological cascades occurring after TBI, the therapies directed to a single mechanism fail in the clinical trials. This has led to the development of the paradigm of a combination therapeutic approach against TBI. …


Ethics Committees For Clinical Experimentation At International Level With A Focus On Italy, Zakira Naureen, Tommaso Beccari, Robert S. Marks, Richard Brown, Lorenzo Lorusso, Derek Pheby, Stanislav Miertus, Karen L. Herbst, Liborio Stuppia, Gary T. Henehan, Benedetto Falsini, Ludovica Lumer, Munis Dundar, Matteo Bertelli, International Bioethical Study Group Jan 2020

Ethics Committees For Clinical Experimentation At International Level With A Focus On Italy, Zakira Naureen, Tommaso Beccari, Robert S. Marks, Richard Brown, Lorenzo Lorusso, Derek Pheby, Stanislav Miertus, Karen L. Herbst, Liborio Stuppia, Gary T. Henehan, Benedetto Falsini, Ludovica Lumer, Munis Dundar, Matteo Bertelli, International Bioethical Study Group

Articles

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus …


External Barriers For Including Parents Of Preterm Infants In A Randomised Clinical Trial In The Neonatal Intensive Care Unit In Sweden: A Descriptive Study, Evalotte Mörelius, Emma Olsson, Charlotte Sahlén Helmer, Ylva Thernström Blomqvist, Charlotte Angelhoff Jan 2020

External Barriers For Including Parents Of Preterm Infants In A Randomised Clinical Trial In The Neonatal Intensive Care Unit In Sweden: A Descriptive Study, Evalotte Mörelius, Emma Olsson, Charlotte Sahlén Helmer, Ylva Thernström Blomqvist, Charlotte Angelhoff

Research outputs 2014 to 2021

© Author(s) (or their employer(s)) 2020. Objectives Performing randomised controlled trials (RCTs) in neonatal intensive care is challenging in many ways. While restrictive inclusion criteria or busy study protocols are obvious barriers, external barriers leading to termination of a study are seldom discussed. The aim of this study was to describe barriers for inclusion of families in neonatal intensive care in an RCT aiming to evaluate the effects of continuous skin-to-skin contact on mood and sleep quality in parents of preterm infants, as well as the quality of parent-infant interaction and salivary cortisol concentrations at the time of discharge. Design …