Scholarly

An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Year: 2021 Volume: 15 Issue: 9 228 - 234 Pages

Abstract: Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits, and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depending on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

Improved Blood Glucose-Insulin Monitoring with Dual-Layer Predictive Control Design

Year: 2018 Volume: 12 Issue: 9 398 - 402 Pages

Authors:
Vahid Nademi

Abstract: In response to widely used wearable medical devices equipped with a continuous glucose monitor (CGM) and insulin pump, the advanced control methods are still demanding to get the full benefit of these devices. Unlike costly clinical trials, implementing effective insulin-glucose control strategies can provide significant contributions to the patients suffering from chronic diseases such as diabetes. This study deals with a key role of two-layer insulin-glucose regulator based on model-predictive-control (MPC) scheme so that the patient’s predicted glucose profile is in compliance with the insulin level injected through insulin pump automatically. It is achieved by iterative optimization algorithm which is called an integrated perturbation analysis and sequential quadratic programming (IPA-SQP) solver for handling uncertainties due to unexpected variations in glucose-insulin values and body’s characteristics. The feasibility evaluation of the discussed control approach is also studied by means of numerical simulations of two case scenarios via measured data. The obtained results are presented to verify the superior and reliable performance of the proposed control scheme with no negative impact on patient safety.

Dosimetric Analysis of Intensity Modulated Radiotherapy versus 3D Conformal Radiotherapy in Adult Primary Brain Tumors: Regional Cancer Centre, India

Year: 2018 Volume: 12 Issue: 2 52 - 57 Pages

Abstract: Radiation therapy has undergone many advancements and evloved from 2D to 3D. Recently, with rapid pace of drug discoveries, cutting edge technology, and clinical trials has made innovative advancements in computer technology and treatment planning and upgraded to intensity modulated radiotherapy (IMRT) which delivers in homogenous dose to tumor and normal tissues. The present study was a hospital-based experience comparing two different conformal radiotherapy techniques for brain tumors. This analytical study design has been conducted at Regional Cancer Centre, India from January 2014 to January 2015. Ten patients have been selected after inclusion and exclusion criteria. All the patients were treated on Artiste Siemens Linac Accelerator. The tolerance level for maximum dose was 6.0 Gyfor lenses and 54.0 Gy for brain stem, optic chiasm and optical nerves as per RTOG criteria. Mean and standard deviation values of PTV98%, PTV 95% and PTV 2% in IMRT were 93.16±2.9, 95.01±3.4 and 103.1±1.1 respectively; for 3DCRT were 91.4±4.7, 94.17±2.6 and 102.7±0.39 respectively. PTV max dose (%) in IMRT and 3D-CRT were 104.7±0.96 and 103.9±1.0 respectively. Maximum dose to the tumor can be delivered with IMRT with acceptable toxicity limits. Variables such as expertise, location of tumor, patient condition, and TPS influence the outcome of the treatment.

Keywords:
IMRT
3D CRT
Brain
tumors
OARs
RTOG.

Properties of Adipose Tissue Derived Mesenchymal Stem Cells with Long-Term Cryopreservation

Year: 2016 Volume: 10 Issue: 3 118 - 122 Pages

Abstract: Adult mesenchymal stem cells (MSCs) have been investigated using preclinical approaches for tissue regeneration. Porcine MSCs (pMSCs) are capable of growing and attaching to plastic with a fibroblast-like morphology and then differentiating into bone, adipose, and cartilage tissues in vitro. This study was conducted to investigate the proliferating abilities, differentiation potentials, and multipotency of miniature pig adipose tissue-derived MSCs (mpAD-MSCs) with or without long-term cryopreservation, considering that cryostorage has the potential for use in clinical applications. After confirming the characteristics of the mpAD-MSCs, we examined the effect of long-term cryopreservation (> 2 years) on expression of cell surface markers (CD34, CD90 and CD105), proliferating abilities (cumulative population doubling level, doubling time, colony-forming unit, and MTT assay) and differentiation potentials into mesodermal cell lineages. As a result, the expression of cell surface markers is similar between thawed and fresh mpAD-MSCs. However, long-term cryopreservation significantly lowered the differentiation potentials (adipogenic, chondrogenic, and osteogenic) of mpAD-MSCs. When compared with fresh mpAD-MSCs, thawed mpAD-MSCs exhibited lower expression of mesodermal cell lineage-related genes such as peroxisome proliferator-activated receptor-g2, lipoprotein lipase, collagen Type II alpha 1, osteonectin, and osteocalcin. Interestingly, long-term cryostoraged mpAD-MSCs exhibited significantly higher cell viability than the fresh mpAD-MSCs. Long-term cryopreservation induced a 30% increase in the cell viability of mpAD-MSCs when compared with the fresh mpAD-MSCs at 5 days after thawing. However, long-term cryopreservation significantly lowered expression of stemness markers such as Oct3/4, Sox2, and Nanog. Furthermore, long-term cryopreservation negatively affected expression of senescence-associated genes such as telomerase reverse transcriptase and heat shock protein 90 of mpAD-MSCs when compared with the fresh mpAD-MSCs. The results from this study might be important for the successful application of MSCs in clinical trials after long-term cryopreservation.

Synthesis of Analogue to Camptothecine

Year: 2011 Volume: 5 Issue: 1 90 - 93 Pages

Abstract: Camptothecin (CPT) is a cytotoxic quinoline alkaloid, which inhibits the DNA enzyme topoisomerase I (topo I). It was discovered in 1966 by M. E. Wall and M. C. Wani in systematic screening of natural products for anticancer drugs. It was isolated from the bark and stem of Camptotheca acuminata (Camptotheca, Happy tree), a tree native in China. CPT showed remarkable anticancer activity in preliminary clinical trials but also low solubility and (high) adverse drug reaction. Because of these disadvantages synthetic and medicinal chemists have developed numerous syntheses of Camptothecine [1][2][3] and various derivatives to increase the benefits of the chemical, with good results. In our method CPT analogues has be six steps starting from available material DL Malic acid.

Ultrasonic System for Diagnosis of Functional Gastrointestinal Disorders: Development, Verification and Clinical Trials

Year: 2007 Volume: 1 Issue: 1 33 - 38 Pages

Abstract: Functional gastrointestinal disorders affect millions of people spread all age regardless of race and sex. There are, however, rare diagnostic methods for the functional gastrointestinal disorders because functional disorders show no evidence of organic and physical causes. Our research group identified recently that the gastrointestinal tract well in the patients with the functional gastrointestinal disorders becomes more rigid than healthy people when palpating the abdominal regions overlaying the gastrointestinal tract. Aim of this study is, therefore, to develop a diagnostic system for the functional gastrointestinal disorders based on ultrasound technique, which can quantify the characteristic above related to the rigidity of the gastrointestinal tract well. Ultrasound system was designed. The system consisted of transmitter, ultrasonic transducer, receiver, TGC, and CPLD, and verified via a phantom test. For the phantom test, ten soft-tissue specimens were harvested from porcine. Five of them were then treated chemically to mimic a rigid condition of gastrointestinal tract well, which was induced by functional gastrointestinal disorders. Additionally, the specimens were tested mechanically to identify if the mimic was reasonable. The customized ultrasound system was finally verified through application to human subjects with/without functional gastrointestinal disorders (Normal and Patient Groups). It was identified from the mechanical test that the chemically treated specimens were more rigid than normal specimen. This finding was favorably compared with the result obtained from the phantom test. The phantom test also showed that ultrasound system well described the specimen geometric characteristics and detected an alteration in the specimens. The maximum amplitude of the ultrasonic reflective signal in the rigid specimens (0.2±0.1Vp-p) at the interface between the fat and muscle layers was explicitly higher than that in the normal specimens (0.1±0.0Vp-p). Clinical tests using our customized ultrasound system for human subject showed that the maximum amplitudes of the ultrasonic reflective signals near to the gastrointestinal tract well for the patient group (2.6±0.3Vp-p) were generally higher than those in normal group (0.1±0.2Vp-p). Here, maximum reflective signals was appeared at 20mm depth approximately from abdominal skin for all human subjects, corresponding to the location of the boundary layer close to gastrointestinal tract well. These results suggest that newly designed diagnostic system based on ultrasound technique may diagnose enough the functional gastrointestinal disorders.

Wireless Neural Stimulator with Adjustable Electrical Quantity

Year: 2014 Volume: 8 Issue: 9 1435 - 1438 Pages

Authors:
Young-Seok Choi

Abstract: The neural stimulation has been gaining much interest in neuromodulation research and clinical trials. For efficiency, there is a need for variable electrical stimulation such as current and voltage stimuli as well as wireless framework. In this regard, we develop the wireless neural stimulator capable of voltage and current stimuli. The system consists of ZigBee which is a wireless communication module and stimulus generator. The stimulus generator with 8-bits resolution enable both mono-polar and bi-polar waveform in voltage (-3.3~3.3V) and current(-330~330µA) stimulus mode which is controllable. The experimental results suggest that the proposed neural stimulator can play a role as an effective approach for neuromodulation.

Suggestion of Ultrasonic System for Diagnosis of Functional Gastrointestinal Disorders: Finite Difference Analysis, Development and Clinical Trials

Year: 2007 Volume: 1 Issue: 1 22 - 28 Pages

Abstract: The disaster from functional gastrointestinal disorders has detrimental impact on the quality of life of the effected population and imposes a tremendous social and economic burden. There are, however, rare diagnostic methods for the functional gastrointestinal disorders. Our research group identified recently that the gastrointestinal tract well in the patients with the functional gastrointestinal disorders becomes more rigid than healthy people when palpating the abdominal regions overlaying the gastrointestinal tract. Objective of current study is, therefore, identify feasibility of a diagnostic system for the functional gastrointestinal disorders based on ultrasound technique, which can quantify the characteristics above. Two-dimensional finite difference (FD) models (one normal and two rigid model) were developed to analyze the reflective characteristic (displacement) on each soft-tissue layer responded after application of ultrasound signals. The FD analysis was then based on elastic ultrasound theory. Validation of the model was performed via comparison of the characteristic of the ultrasonic responses predicted by FD analysis with that determined from the actual specimens for the normal and rigid conditions. Based on the results from FD analysis, ultrasound system for diagnosis of the functional gastrointestinal disorders was developed and clinically tested via application of it to 40 human subjects with/without functional gastrointestinal disorders who were assigned to Normal and Patient Groups. The FD models were favorably validated. The results from FD analysis showed that the maximum displacement amplitude in the rigid models (0.12 and 0.16) at the interface between the fat and muscle layers was explicitly less than that in the normal model (0.29). The results from actual specimens showed that the maximum amplitude of the ultrasonic reflective signal in the rigid models (0.2±0.1Vp-p) at the interface between the fat and muscle layers was explicitly higher than that in the normal model (0.1±0.2 Vp-p). Clinical tests using our customized ultrasound system showed that the maximum amplitudes of the ultrasonic reflective signals near to the gastrointestinal tract well for the patient group (2.6±0.3 Vp-p) were generally higher than those in normal group (0.1±0.2 Vp-p). Here, maximum reflective signals was appeared at 20mm depth approximately from abdominal skin for all human subjects, corresponding to the location of the boundary layer close to gastrointestinal tract well. These findings suggest that our customized ultrasound system using the ultrasonic reflective signal may be helpful to the diagnosis of the functional gastrointestinal disorders.

Antidiabetic and Antioxidative Activities of Butyrolactone I from Aspergillus terreus MC751

Year: 2012 Volume: 6 Issue: 10 883 - 888 Pages

Abstract: The bioassay-guided isolation and purification of an ethyl acetate extract of Aspergillus terreus MC751 led to the characterization of butyrolactone I as an antidiabetic and antioxidant. The antidiabetic activity of butyrolactone I was evaluated by α- glucosidase and α-amylase inhibition assays. Butyrolactone I demonstrated significant concentration-dependent, mixed-type inhibitory activity against yeast α-glucosidase with an IC50 of 54μM. However, the compound exhibited less activity against rat intestinal α-glucosidase and α-amylase. This is the first report on α-glucosidase inhibitory activity of butyrolactone I. The antioxidative activity of butyrolactone I was evaluated based on scavenging effects on 1,1- diphenyl-2-picrylhydrazyl (DPPH) (IC50 =51 μM) and hydrogen peroxide (IC50= 141 μM) radicals as well as a reducing power assay. The results suggest that butyrolactone I is a promising antidiabetic as well as antioxidant and should be considered for clinical trials.

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