scholarly journals Multifunctional Gold Nanoparticles for Improved Diagnostic and Therapeutic Applications: A Review

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Nicole Remaliah Samantha Sibuyi ◽  
Koena Leah Moabelo ◽  
Adewale Oluwaseun Fadaka ◽  
Samantha Meyer ◽  
Martin Opiyo Onani ◽  
...  
Keyword(s):  
Gold Nanoparticles ◽  
Clinical Trials ◽  
Anticancer Agents ◽  
Metallic Nanoparticles ◽  
Gene Transfection ◽  
The United States ◽  
Disease Diagnosis ◽  
Great Promise ◽  
Potential Health ◽  
United States Food

AbstractThe medical properties of metals have been explored for centuries in traditional medicine for the treatment of infections and diseases and still practiced to date. Platinum-based drugs are the first class of metal-based drugs to be clinically used as anticancer agents following the approval of cisplatin by the United States Food and Drug Administration (FDA) over 40 years ago. Since then, more metals with health benefits have been approved for clinical trials. Interestingly, when these metals are reduced to metallic nanoparticles, they displayed unique and novel properties that were superior to their bulk counterparts. Gold nanoparticles (AuNPs) are among the FDA-approved metallic nanoparticles and have shown great promise in a variety of roles in medicine. They were used as drug delivery, photothermal (PT), contrast, therapeutic, radiosensitizing, and gene transfection agents. Their biomedical applications are reviewed herein, covering their potential use in disease diagnosis and therapy. Some of the AuNP-based systems that are approved for clinical trials are also discussed, as well as the potential health threats of AuNPs and some strategies that can be used to improve their biocompatibility. The reviewed studies offer proof of principle that AuNP-based systems could potentially be used alone or in combination with the conventional systems to improve their efficacy.

Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths

1996 ◽  
Vol 24 (3) ◽  
pp. 252-259 ◽  
Author(s):  
Benjamin Freedman ◽  
Kathleen Cranley Glass ◽  
Charles Weijer
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
The United States ◽  
Human Experimentation ◽  
Medical Interventions ◽  
Placebo Controls ◽  
United States Food ◽  
Considerable Controversy ◽  
States Food ◽  
Continued Use

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration (FDA), to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration.

scholarly journals The United States Food and Drug Administration and Noninferiority Margins in Clinical Trials of Antimicrobial Agents

2002 ◽  
Vol 34 (6) ◽  
pp. 879-881 ◽  
Author(s):  
John H. Powers ◽  
David B. Ross ◽  
Erica Brittain ◽  
Renata Albrecht ◽  
Mark J. Goldberger
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Drug Administration ◽  
Antimicrobial Agents ◽  
Food And Drug Administration ◽  
The United States ◽  
United States Food ◽  
States Food

scholarly journals Immunotherapies in Genitourinary Oncology: Where Are We Now? Where Are We Going?

Cancers ◽  
2021 ◽  
Vol 13 (20) ◽  
pp. 5065
Author(s):  
Albert Jang ◽  
David M. Adler ◽  
Grant P. Rauterkus ◽  
Mehmet A. Bilen ◽  
Pedro C. Barata
Keyword(s):  
Clinical Trials ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
The United States ◽  
The Past ◽  
United States Food ◽  
States Food ◽  
Genitourinary Cancers ◽  
Tumor Types

For decades, limited options existed to treat metastatic genitourinary cancers, including treatment options that could be classified as immunotherapy. Historically, immunotherapy centered on systemic cytokines for the treatment of metastatic kidney cancer, which had several adverse effects, as well as the Bacillus Calmette–Guérin vaccine for non-metastatic bladder cancer. Within the past decade, advances in immunotherapy have led to several approvals from the United States Food and Drug Administration, particularly in the field of immune checkpoint inhibition. Immune checkpoint inhibitors (ICIs) are now being used extensively to treat multiple solid tumors, including kidney and bladder cancers, and they are also being tested in many other cancers. Despite encouraging data from phase 2/3 clinical trials, less is known about biomarkers that may predict better response to ICIs. The effect of ICIs in genitourinary cancers is heterogeneous, with some tumor types having little clinical data available, or ICIs having limited activity in other tumors. In this review, we briefly discuss approved immunotherapy agents prior to the time of ICIs. Then, given the emergence of this class of agents, we summarize the several important ICIs and the clinical trials that led to their approval. Finally, we mention ongoing and future clinical trials.

scholarly journals Nanodiagnostics: A New Frontier for Clinical Laboratory Medicine

2006 ◽  
Vol 52 (7) ◽  
pp. 1238-1246 ◽  
Author(s):  
Hassan ME Azzazy ◽  
Mai MH Mansour ◽  
Steven C Kazmierczak
Keyword(s):  
Gold Nanoparticles ◽  
Magnetic Nanoparticles ◽  
Clinical Laboratory ◽  
Semiconductor Nanocrystals ◽  
Specific Antigen ◽  
Amyloid Β ◽  
Great Promise ◽  
Potential Health ◽  
Increased Sensitivity ◽  
Diagnostic Applications

Abstract Background: The use of nanotechnologies for diagnostic applications shows great promise to meet the rigorous demands of the clinical laboratory for sensitivity and cost-effectiveness. New nanodiagnostic tools include quantum dots (QDs), gold nanoparticles, and cantilevers. QDs, which are the most promising nanostructures for diagnostic applications, are semiconductor nanocrystals characterized by high photostability, single-wavelength excitation, and size-tunable emission. QDs and magnetic nanoparticles can be used for barcoding of specific analytes. Gold and magnetic nanoparticles are key components of the bio-barcode assay, which has been proposed as a future alternative to the PCR. Methods: We examined articles published over the past 10 years investigating the use of QDs, gold nanoparticles, cantilevers, and other nanotechnologies in promising diagnostic applications. Results: Several nanodiagnostic assays have been developed, including a QD-based assay capable of detecting biotinylated prostate-specific antigen (PSA) at 0.38 ng/L, a bio-barcode assay capable of detecting 30 amol/L PSA in a 10-μL sample, and another able to detect 50 molecules of the Alzheimer marker amyloid β-derived diffusible ligand in 10 μL of cerebrospinal fluid. Conclusions: Nanodiagnostics promise increased sensitivity, multiplexing capabilities, and reduced cost for many diagnostic applications as well as intracellular imaging. Further work is needed to fully optimize these diagnostic nanotechnologies for clinical laboratory setting and to address the potential health and environmental risks related to QDs.

scholarly journals Microneedles Drug Delivery Systems for Treatment of Cancer: A Recent Update

Pharmaceutics ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 1101
Author(s):  
Aravindram Attiguppe Seetharam ◽  
Hani Choudhry ◽  
Muhammed A. Bakhrebah ◽  
Wesam H. Abdulaal ◽  
Maram Suresh Gupta ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Clinical Trials ◽  
The United States ◽  
Sensor Technology ◽  
3 Dimensional ◽  
Non Invasive ◽  
Carcinoma Prostate ◽  
United States Food ◽  
Pros And Cons ◽  
States Food

Microneedles (MNs) are tiny needle like structures used in drug delivery through layers of the skin. They are non-invasive and are associated with significantly less or no pain at the site of administration to the skin. MNs are excellent in delivering both small and large molecules to the subjects in need thereof. There exist several strategies for drug delivery using MNs, wherein each strategy has its pros and cons. Research in this domain lead to product development and commercialization for clinical use. Additionally, several MN-based products are undergoing clinical trials to evaluate its safety, efficacy, and tolerability. The present review begins by providing bird’s-eye view about the general characteristics of MNs followed by providing recent updates in the treatment of cancer using MNs. Particularly, we provide an overview of various aspects namely: anti-cancerous MNs that work based on sensor technology, MNs for treatment of breast cancer, skin carcinoma, prostate cancer, and MNs fabricated by additive manufacturing or 3 dimensional printing for treatment of cancer. Further, the review also provides limitations, safety concerns, and latest updates about the clinical trials on MNs for the treatment of cancer. Furthermore, we also provide a regulatory overview from the “United States Food and Drug Administration” about MNs.

scholarly journals Dendritic Cell-Based Immunotherapy for Prostate Cancer

2010 ◽  
Vol 2010 ◽  
pp. 1-8 ◽  
Author(s):  
Hanka Jähnisch ◽  
Susanne Füssel ◽  
Andrea Kiessling ◽  
Rebekka Wehner ◽  
Stefan Zastrow ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Mononuclear Cells ◽  
The United States ◽  
Peripheral Blood Mononuclear ◽  
United States Food ◽  
Clinical Responses ◽  
Antigen Presenting

Dendritic cells (DCs) are professional antigen-presenting cells (APCs), which display an extraordinary capacity to induce, sustain, and regulate T-cell responses providing the opportunity of DC-based cancer vaccination strategies. Thus, clinical trials enrolling prostate cancer patients were conducted, which were based on the administration of DCs loaded with tumor-associated antigens. These clinical trials revealed that DC-based immunotherapeutic strategies represent safe and feasible concepts for the induction of immunological and clinical responses in prostate cancer patients. In this context, the administration of the vaccine sipuleucel-T consisting of autologous peripheral blood mononuclear cells including APCs, which were pre-exposedin vitroto the fusion protein PA2024, resulted in a prolonged overall survival among patients with metastatic castration-resistent prostate cancer. In April 2010, sipuleucel-T was approved by the United States Food and Drug Administration for prostate cancer therapy.

scholarly journals Small Extracellular Vesicles: A Novel Avenue for Cancer Management

2021 ◽  
Vol 11 ◽  
Author(s):  
Yanan Gao ◽  
You Qin ◽  
Chao Wan ◽  
Yajie Sun ◽  
Jingshu Meng ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Extracellular Vesicles ◽  
Anticancer Agents ◽  
Early Stage ◽  
Cell Types ◽  
The United States ◽  
Extracellular Vesicle ◽  
Cancer Therapies ◽  
Clinical Implementation ◽  
Cancer Management

Extracellular vesicles are small membrane particles derived from various cell types. EVs are broadly classified as ectosomes or small extracellular vesicles, depending on their biogenesis and cargoes. Numerous studies have shown that EVs regulate multiple physiological and pathophysiological processes. The roles of small extracellular vesicles in cancer growth and metastasis remain to be fully elucidated. As endogenous products, small extracellular vesicles are an ideal drug delivery platform for anticancer agents. However, several aspects of small extracellular vesicle biology remain unclear, hindering the clinical implementation of small extracellular vesicles as biomarkers or anticancer agents. In this review, we summarize the utility of cancer-related small extracellular vesicles as biomarkers to detect early-stage cancers and predict treatment outcomes. We also review findings from preclinical and clinical studies of small extracellular vesicle-based cancer therapies and summarize interventional clinical trials registered in the United States Food and Drug Administration and the Chinese Clinical Trials Registry. Finally, we discuss the main challenges limiting the clinical implementation of small extracellular vesicles and recommend possible approaches to address these challenges.

scholarly journals Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets

2021 ◽  
Vol 40 (1) ◽  
Author(s):  
Xiang-Yuan Luo ◽  
Kong-Ming Wu ◽  
Xing-Xing He
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trials ◽  
Checkpoint Inhibitors ◽  
The United States ◽  
New Drugs ◽  
Clinical Phase ◽  
United States Food ◽  
Fundamental Research ◽  
States Food ◽  
Health Burdens

AbstractAlthough hepatocellular carcinoma (HCC) is one of the deadliest health burdens worldwide, few drugs are available for its clinical treatment. However, in recent years, major breakthroughs have been made in the development of new drugs due to intensive fundamental research and numerous clinical trials in HCC. Traditional systemic therapy schemes and emerging immunotherapy strategies have both advanced. Between 2017 and 2020, the United States Food and Drug Administration (FDA) approved a variety of drugs for the treatment of HCC, including multikinase inhibitors (regorafenib, lenvatinib, cabozantinib, and ramucirumab), immune checkpoint inhibitors (nivolumab and pembrolizumab), and bevacizumab combined with atezolizumab. Currently, there are more than 1000 ongoing clinical trials involving HCC, which represents a vibrant atmosphere in the HCC drug research and development field. Additionally, traditional Chinese medicine approaches are being gradually optimized. This review summarizes FDA-approved agents for HCC, elucidates promising agents evaluated in clinical phase I/II/III trials and identifies emerging targets for HCC treatment. In addition, we introduce the development of HCC drugs in China. Finally, we discuss potential problems in HCC drug therapy and possible future solutions and indicate future directions for the development of drugs for HCC treatment.

Hamas and Civil Society in Gaza

2013 ◽  
Author(s):  
Sara Roy
Keyword(s):  
United States ◽  
Political Violence ◽  
West Bank ◽  
Gaza Strip ◽  
Social Institutions ◽  
The United States ◽  
Great Promise ◽  
Religious Congregations ◽  
Regional Dynamics ◽  
Second Intifada

Many in the United States and Israel believe that Hamas is nothing but a terrorist organization, and that its social sector serves merely to recruit new supporters for its violent agenda. Based on extensive fieldwork in the Gaza Strip and West Bank during the critical period of the Oslo peace process, this book shows how the social service activities sponsored by the Islamist group emphasized not political violence but rather community development and civic restoration. The book demonstrates how Islamic social institutions in Gaza and the West Bank advocated a moderate approach to change that valued order and stability, not disorder and instability; were less dogmatically Islamic than is often assumed; and served people who had a range of political outlooks and no history of acting collectively in support of radical Islam. These institutions attempted to create civic communities, not religious congregations. They reflected a deep commitment to stimulate a social, cultural, and moral renewal of the Muslim community, one couched not only—or even primarily—in religious terms. Vividly illustrating Hamas's unrecognized potential for moderation, accommodation, and change, the book also traces critical developments in Hamas' social and political sectors through the Second Intifada to today, and offers an assessment of the current, more adverse situation in the occupied territories. The Oslo period held great promise that has since been squandered. This book argues for more enlightened policies by the United States and Israel, ones that reflect Hamas' proven record of nonviolent community building. A new afterword discusses how Hamas has been affected by changing regional dynamics and by recent economic and political events in Gaza, including failed attempts at reconciliation with Fatah.

Developing a Clinical Trials Infrastructure in the United States

2012 ◽  
Vol 2 (5) ◽  
Author(s):  
Paul Eisenberg ◽  
◽  
Petra Kaufmann ◽  
Ellen Sigal ◽  
Janet Woodcock ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States
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