Endoscopic and Electroporation Therapy of Paranasal Sinus Tumors

The purpose of this article is to introduce the concept of endoscopic and electroporation therapy for the treatment of sinonasal carcinomas. Electroporation therapy is a technique that combines intralesional injection of bleomycin combined with application of high-voltage square wave electrical impulse into the tumor. A transient increase in cell membrane permeability allows intracellular entry of bleomycin, with subsequent cytotoxicity. Two cases of sinonasal cancer were treated with this technique. One patient had complete response and is free of disease at 20 months. The other had partial response with control of the disease up to a year. Endoscopic electroporation therapy is potentially a minimally invasive method for the treatment of sinonasal malignancies in an experimental setting where other treatment options do not exist. Phase II/III national clinical trials have been initiated to study the efficacy of electroporation therapy.

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Sirolimus in Infants with Multiple Cardiac Rhabdomyomas Associated with Tuberous Sclerosis Complex

Case Reports in Oncology ◽

10.1159/000490662 ◽

2018 ◽

Vol 11 (2) ◽

pp. 425-430 ◽

Cited By ~ 2

Author(s):

Maurizio Lucchesi ◽

Enrico Chiappa ◽

Flavio Giordano ◽

Francesco Mari ◽

Lorenzo Genitori ◽

...

Keyword(s):

Clinical Trials ◽

Case Report ◽

Side Effects ◽

Tuberous Sclerosis ◽

Mtor Inhibitor ◽

Complete Response ◽

The Other ◽

Cardiac Response ◽

Neonatal Deaths ◽

Tumor Debulking

Introduction: Cardiac rhabdomyomas represent a frequent manifestation of tuberous sclerosis. Tumor growth, mainly prenatally, can result in intrauterine fetal or neonatal deaths in almost 10% of patients. Case Report: We treated 3 consecutive infants aged less than 12 months with sirolimus, an oral mTOR inhibitor. All patients achieved significant reductions in cardiac rhabdomyomas. A complete response was documented in 2 patients, while a partial response with tumor debulking greater than 50% was seen in the other one. The median time to best cardiac response was 1.9 months in all patients, and 3.3 months in those with complete response. The side effects profile was acceptable. Conclusion: Sirolimus may have a significant role in promoting natural regression of cardiac rhabdomyomas. Prospective clinical trials are needed.

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Interferon Therapy for Hypertrophic Scars and Keloids

10.5772/intechopen.96789 ◽

2021 ◽

Author(s):

Amalorpava Mary Loordhuswamy ◽

Santhini Elango

Keyword(s):

Extracellular Matrix ◽

Clinical Trials ◽

Interferon Therapy ◽

Collagen Synthesis ◽

The Other ◽

Intralesional Injection ◽

Hypertrophic Scars ◽

Co2 Lasers ◽

Combinatorial Therapy ◽

The Family

Interferons (IFNs) belong to the family of cytokines are widely used to treat keloids owing to their ability to increase collagenase activity thereby reducing the production of collagen and other extracellular matrix (ECM). Intralesional injection of IFN-α – 2b increases the collagenase level by inhibiting the secretion of metalloproteinases, an inhibitor of collagenase. Moreover, the anti-fibrotic activity of IFNs, interfere with fibroblast mediated collagen synthesis. On the other hand, combinatorial therapy has been preferred recently along with IFN due to its side effects observed in various clinical trials conducted only with IFN. Triamcinolone acetonide (TAC) and CO2 lasers along with IFNs are found to be the potential therapy for the treatment of scars and keloids. In this chapter, IFN mediated therapy for the treatment of scars and keloids, its benefits and limitations and the advantages of combinatorial therapy with the appropriate literature support are discussed.

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Systemic therapy for neuroendocrine tumours of gastroenteropancreatic origin

Endocrine Related Cancer ◽

10.1677/erc-09-0108 ◽

2010 ◽

Vol 17 (1) ◽

pp. R75-R90 ◽

Cited By ~ 34

Author(s):

Bristi Basu ◽

Bhawna Sirohi ◽

Pippa Corrie

Keyword(s):

Clinical Trials ◽

Systemic Therapy ◽

Neuroendocrine Tumours ◽

Treatment Options ◽

Evidence Base ◽

Review Article ◽

The Other ◽

Treatment Modalities ◽

Number Of Treatment

Systemic therapy is one of a number of treatment options routinely used in the management of advanced, unresectable neuroendocrine tumours (NETs). In contrast to many of the other NET treatment modalities, there is at least some evidence base to justify its use. Even so, well-designed clinical trials are limited, since conducting clinical research in this complex group of rare cancers is challenging. The remit of this review article is to summarise the oncology literature and explain the role of systemic therapy in treating NETs of gastroenteropancreatic origin, identifying benefits and limitations. The molecular biology of NETs is now being unravelled, which affords new opportunities for development of mechanism-driven therapies. The rationale for some of the newer systemic targeted therapies that are showing promise in the clinic is discussed.

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Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry

Journal of Basic and Clinical Physiology and Pharmacology ◽

10.1515/jbcpp-2020-0208 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Angelika Batta ◽

Raj Khirasaria ◽

Vinod Kapoor ◽

Deepansh Varshney

Keyword(s):

Clinical Trials ◽

De Novo ◽

Treatment Options ◽

Drug Repurposing ◽

Trial Registry ◽

Therapeutic Treatment ◽

Clinical Trial Registry ◽

Clear Cut ◽

Therapeutic Trials ◽

Microsoft Office

AbstractObjectivesWith the emergence of Novel corona virus, hunt for finding a preventive and therapeutic treatment options has already begun at a rapid pace with faster clinical development programs. The present study was carried out to give an insight of therapeutic interventional trials registered under clinical trial registry of India (CTRI) for COVID-19 pandemic.MethodsAll trials registered under CTRI were evaluated using keyword “COVID” from its inception till 9th June 2020. Out of which, therapeutic interventional studies were chosen for further analysis. Following information was collected for each trial: type of therapeutic intervention (preventive/therapeutic), treatment given, no. of centers (single center/multicentric), type of institution (government/private), study design (randomized/single-blinded/double-blinded) and sponsors (Government/private). Microsoft Office Excel 2007 was used for tabulation and analysis.ResultsThe search yielded total of 205 trials, out of which, 127 (62%) trials were interventional trials. Out of these, 71 (56%) were AYUSH interventions, 36 (28.3%) tested drugs, 9 (7%) tested a nondrug intervention, rest were nutraceuticals and vaccines. About 66 (56%) were therapeutic trials. Majority were single-centered trials, i.e. 87 (73.7%). Trials were government funded in 57 (48.3%) studies. Majority were randomized controlled trials, i.e. 67 (56.8%). AYUSH preparations included AYUSH-64, Arsenic Album, SamshamaniVati etc.ConclusionsThe number of therapeutic interventional clinical trials was fair in India. A clear-cut need exists for an increase in both quantity and quality of clinical trials for COVID-19. Drug repurposing approach in all systems of medicine can facilitate prompt clinical decisions at lower costs than de novo drug development.

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Variation in treatment preferences of pulmonary exacerbations among Australian and New Zealand cystic fibrosis physicians

BMJ Open Respiratory Research ◽

10.1136/bmjresp-2021-000956 ◽

2021 ◽

Vol 8 (1) ◽

pp. e000956

Author(s):

Grace Currie ◽

Anna Tai ◽

Tom Snelling ◽

André Schultz

Keyword(s):

Cystic Fibrosis ◽

Clinical Trials ◽

New Zealand ◽

Treatment Options ◽

Early Response ◽

Treatment Preferences ◽

Dornase Alfa ◽

Clinical Scenarios ◽

Professional Opinion ◽

Pulmonary Exacerbations

BackgroundDespite advances in cystic fibrosis (CF) management and survival, the optimal treatment of pulmonary exacerbations remains unclear. Understanding the variability in treatment approaches among physicians might help prioritise clinical uncertainties to address through clinical trials.MethodsPhysicians from Australia and New Zealand who care for people with CF were invited to participate in a web survey of treatment preferences for CF pulmonary exacerbations. Six typical clinical scenarios were presented; three to paediatric and another three to adult physicians. For each scenario, physicians were asked to choose treatment options and provide reasons for their choices.ResultsForty-nine CF physicians (31 paediatric and 18 adult medicine) participated; more than half reported 10+ years of experience. There was considerable variation in primary antibiotic selection; none was preferred by more than half of respondents in any scenario. For secondary antibiotic therapy, respondents consistently preferred intravenous tobramycin and a third antibiotic was rarely prescribed, except in one scenario describing an adult patient. Hypertonic saline nebulisation and twice daily chest physiotherapy was preferred in most scenarios while dornase alfa use was more variable. Most CF physicians (>80%) preferred to change therapy if there was no early response. Professional opinion was the most common reason for antibiotic choice.ConclusionsVariation exists among CF physicians in their preferred choice of primary antibiotic and use of dornase alfa. These preferences are driven by professional opinion, possibly reflecting a lack of evidence to base policy recommendations. Evidence from high-quality clinical trials is needed to inform physician decision making.

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Ingredients, Functionality, and Safety of the Japanese Traditional Sweet Drink Amazake

Journal of Fungi ◽

10.3390/jof7060469 ◽

2021 ◽

Vol 7 (6) ◽

pp. 469

Author(s):

Atsushi Kurahashi

Keyword(s):

Clinical Trials ◽

Blood Glucose ◽

Bowel Movement ◽

Skin Barrier ◽

Fermented Food ◽

The Other ◽

Added Sugar ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Main Components

The sweet drink amazake is a fermented food made from Aspergillus oryzae and related koji molds in Japan. There are two types of drinks called amazake, one made from koji (koji amazake) and the other made from sake lees, a by-product of sake (sakekasu amazake). The sweetness of koji amazake is from glucose, derived from starch broken down by A. oryzae amylase. The other, sakekasu amazake, depends on added sugar. The main components are glucose and sucrose, but they also contain more than 300 other ingredients. Koji amazake contains oligosaccharides and ergothioneine, and sakekasu amazake has a resistant protein and α-ethyl glucoside, which are characteristic ingredients of each amazake. However, there are also common ingredients such as glycosylceramide. Functionality is known to include anti-fatigue, bowel movement, skin barrier, and other effects on human health. In particular, the bowel movement-improving effects have been well studied for both amazakes. These functions result from ingesting approximately 100 mL per day, but human clinical trials have clarified that this amount has no effect on blood glucose levels and weight gain. In the future, the identification of substances associated with each function is required.

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Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

Pharmaceuticals ◽

10.3390/ph14010051 ◽

2021 ◽

Vol 14 (1) ◽

pp. 51

Author(s):

Brinda Balasubramanian ◽

Simran Venkatraman ◽

Kyaw Zwar Myint ◽

Tavan Janvilisri ◽

Kanokpan Wongprasert ◽

...

Keyword(s):

Clinical Trials ◽

Targeted Therapy ◽

Drug Development ◽

Surgical Resection ◽

Treatment Options ◽

Standard Of Care ◽

Time Data ◽

Current Standard ◽

Innovative Drug ◽

Curative Intent

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

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Therapeutic Features and Updated Clinical Trials of Mesenchymal Stem Cell (MSC)-Derived Exosomes

Journal of Clinical Medicine ◽

10.3390/jcm10040711 ◽

2021 ◽

Vol 10 (4) ◽

pp. 711

Author(s):

Byung-Chul Lee ◽

Insung Kang ◽

Kyung-Rok Yu

Keyword(s):

Clinical Trials ◽

Therapeutic Agent ◽

Therapeutic Potential ◽

Therapeutic Option ◽

Treatment Options ◽

Genetic Material ◽

Experimental Models ◽

Attractive Alternative ◽

Cell Based Therapy ◽

Cellular Rejection

Identification of the immunomodulatory and regenerative properties of mesenchymal stem cells (MSCs) have made them an attractive alternative therapeutic option for diseases with no effective treatment options. Numerous clinical trials have followed; however, issues such as infusional toxicity and cellular rejection have been reported. To address these problems associated with cell-based therapy, MSC exosome therapy was developed and has shown promising clinical outcomes. MSC exosomes are nanosized vesicles secreted from MSCs and represent a non-cellular therapeutic agent. MSC exosomes retain therapeutic features of the cells from which they originated including genetic material, lipids, and proteins. Similar to MSCs, exosomes can induce cell differentiation, immunoregulation, angiogenesis, and tumor suppression. MSC exosomes have therefore been employed in several experimental models and clinical studies. Here, we review the therapeutic potential of MSC-derived exosomes and summarize currently ongoing clinical trials according to disease type. In addition, we propose several functional enhancement strategies for the effective clinical application of MSC exosome therapy.

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Re-use of erlotinib in a patient using osimertinib after erlotinib, case report

Journal of Oncology Pharmacy Practice ◽

10.1177/10781552211019108 ◽

2021 ◽

pp. 107815522110191

Author(s):

Pinar Gursoy

Keyword(s):

Lung Cancer ◽

Case Report ◽

Treatment Options ◽

Resistance Mutation ◽

Growth Factor Receptor ◽

Complete Response ◽

Egfr Mutations ◽

T790m Mutation ◽

Development Of Resistance ◽

Exon 19

Introduction Most patients with non-small-cell lung cancer tumors that have epidermal growth factor receptor (EGFR) mutations have deletion mutations in exon 19 or exon 21, or both.In recent years, targeted therapies in lung cancer have increased survival, but the development of resistance to these drugs poses a major problem. Thesubstitution of methionineforthreonine at position 790 (T790M) mutation,is primarily responsible for this resistance. However, after osimertinib used in T790M positivepatients treatment options are generally limited to chemotherapy. Case report We reported the efficacy of erlotinib, which we reapplied due to the disappearance of the resistance mutation after osimertinib in a 68-year-old patient using osimertinib after erlotinib. Management and outcome: In the patient using erlotinib due to exon 19 deletion when progression was observed and T790M positivity was detected, osimertinib treatment was initiated. However, when T790M was found to be negative with rebiopsy in progression after osimertinib, a complete response was achieved by restarting erlotinib. Discussion The strategy of restarting erlotinib treatment with negative T790M mutation detected in biopsies of patients with osimertinib resistance may be an acceptable treatment option.

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Comparative Analysis of Geolocation Information through Mobile-Devices under Different COVID-19 Mobility Restriction Patterns in Spain

ISPRS International Journal of Geo-Information ◽

10.3390/ijgi10020073 ◽

2021 ◽

Vol 10 (2) ◽

pp. 73

Author(s):

Raquel Pérez-Arnal ◽

David Conesa ◽

Sergio Alvarez-Napagao ◽

Toyotaro Suzumura ◽

Martí Català ◽

...

Keyword(s):

Mobile Phones ◽

Human Mobility ◽

The Other ◽

Data Sources ◽

Experimental Setting ◽

Mobile Data ◽

Restriction Patterns ◽

Mobility Data ◽

The World ◽

Proper Interpretation

The COVID-19 pandemic is changing the world in unprecedented and unpredictable ways. Human mobility, being the greatest facilitator for the spread of the virus, is at the epicenter of this change. In order to study mobility under COVID-19, to evaluate the efficiency of mobility restriction policies, and to facilitate a better response to future crisis, we need to understand all possible mobility data sources at our disposal. Our work studies private mobility sources, gathered from mobile-phones and released by large technological companies. These data are of special interest because, unlike most public sources, it is focused on individuals rather than on transportation means. Furthermore, the sample of society they cover is large and representative. On the other hand, these data are not directly accessible for anonymity reasons. Thus, properly interpreting its patterns demands caution. Aware of that, we explore the behavior and inter-relations of private sources of mobility data in the context of Spain. This country represents a good experimental setting due to both its large and fast pandemic peak and its implementation of a sustained, generalized lockdown. Our work illustrates how a direct and naive comparison between sources can be misleading, as certain days (e.g., Sundays) exhibit a directly adverse behavior. After understanding their particularities, we find them to be partially correlated and, what is more important, complementary under a proper interpretation. Finally, we confirm that mobile-data can be used to evaluate the efficiency of implemented policies, detect changes in mobility trends, and provide insights into what new normality means in Spain.

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