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Publisher: Medip Academy   (Total: 12 journals)   [Sort by number of followers]

Showing 1 - 12 of 12 Journals sorted alphabetically
Intl. J. of Advances in Medicine     Open Access   (Followers: 2)
Intl. J. of Basic & Clinical Pharmacology     Open Access   (Followers: 3)
Intl. J. of Clinical Trials     Open Access   (Followers: 2)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 5)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 4)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access  
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 11)
Intl. J. of Research in Dermatology     Open Access   (Followers: 1)
Intl. J. of Research in Medical Sciences     Open Access   (Followers: 5)
Intl. J. of Research in Orthopaedics     Open Access  
Intl. J. of Scientific Reports     Open Access   (Followers: 2)
Intl. Surgery J.     Open Access   (Followers: 1)
Journal Cover
International Journal of Clinical Trials
Number of Followers: 2  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • Addressing the unmet need in respiratory viruses: an interdisciplinary
           analysis of product development pipeline in Asia

    • Authors: Jelle J. Feddema, Eric Claassen
      Pages: 151 - 160
      Abstract: Background: Respiratory tract infections (RTIs) pose a significant burden on health systems worldwide. Progress has been booked in reducing RTI disease burden through development of diagnostics, therapeutics and vaccines, though most efforts often fail to address the contribution of non-influenza viruses. Increasing awareness and the prevailing unmet need has resulted in the establishment of initiatives that aim to explore ways in which to extend innovation efforts for influenza to the broad range of respiratory viruses. This study will provide a detailed description of the state of the RTI market in Asia.Methods: By developing a dataset containing data from patent documents and clinical trials (CTs) we aimed to provide a detailed description of the RTI market in Asia.Results: We found a downward patent filing trend in respiratory diagnostics but a high number of phase 3 studies. A strong preference for the development of therapeutics and vaccines targeting bacterial pneumonia and influenza became apparent, whereas less attention is given towards product development targeting non-influenza viruses.Conclusions: The findings indicate a mature respiratory diagnostics market with minor industrial interest but at the same time an evolving RTI CT market with a strong late-stage pipeline. Asia represents only a handful of studies related to non-influenza viruses, mostly conducted by non-profit organisations. The business segment appears to focus upon product development for more profitable respiratory infections thereby suggesting that involvement and engagement of the industry within global initiatives and efforts to increase innovation for non-influenza viruses is not optimal.
      PubDate: 2018-10-24
      DOI: 10.18203/2349-3259.ijct20184397
      Issue No: Vol. 5, No. 4 (2018)
       
  • High-throughput image labeling and quality control for clinical trials
           using machine learning

    • Authors: Robert J. Harris, Pangyu Teng, Mahesh Nagarajan, Liza Shrestha, Xiang Lu, Bharath Ramakrishna, Peiyun Lu, Theo Sanford, Heather Clem, Megan McRoberts, Jonathan Goldin, Matt Brown
      Pages: 161 - 169
      Abstract: Background: Manually importing and analyzing image data can be time-consuming, prone to human error, and costly for large clinical trial datasets. This can lead to delays in quality control (QC) feedback to imaging sites and in obtaining data analysis results. Herein we describe the creation and application of a high-throughput review process for import, classification, labeling and QC of large multimodal clinical trial image datasets.Methods: Automated methods were used to remove patient identifying information, extract image header data, and filter image data for usability. A convolutional neural net was applied to estimate anatomy for CT images. Internal scores were assigned for each image series to identify the optimal series for labeling and reading of each anatomical region. Image QC reports were automatically generated for all patients.Results: In combined studies for which 204,492 series were received, 27,841 series were identified as usable and 13,415 series were labeled. Using this high-throughput method, total work-hours required per time point were reduced by an approximate factor of ten when compared to traditional review and labeling methods. Our anatomic classification system identified 95.7% of image series correctly, with the remaining series being manually corrected before labeling and analysis.Conclusions: A high-throughput image analysis pipeline was implemented in a large combined dataset of clinical trial image series. This pipeline can be applied across other studies and modalities for fast image data characterization, labeling and QC.
      PubDate: 2018-10-24
      DOI: 10.18203/2349-3259.ijct20184398
      Issue No: Vol. 5, No. 4 (2018)
       
  • A post marketing randomized placebo controlled study to evaluate the
           efficacy of study product UPLATĀ® (Carica papaya leaf extract + Tinospora
           cordifolia extract) in the cancer patients with thrombocytopenia induced
           by chemotherapy

    • Authors: Rajeev Tiwari, Deepak Kumar Mandal, Jigar Patel
      Pages: 170 - 176
      Abstract: Background: Thrombocytopenia refers to abnormal decrease in platelet count in an individual. The condition may rise at different grades of severity in cancer patients under chemotherapy. In most of the cases, thrombocytopenic condition of cancer patient becomes a major therapy limiting factor. Generally, the treatment of thrombocytopenia lies in dose reduction and/or dose delay but this may adversely affect the treatment plan of cancer. Therefore, managing chemotherapy induced thrombocytopenia is still a challenge. This study was conducted to examine the platelet count improving effect of marketed product UPLAT® (Carica papaya leaf extract + Tinospora cordifolia extract) in cancer patients with chemotherapy induced thrombocytopenia (CIT).Methods: Fourty (40) subjects were recruited as ‘case’ and twenty (20) as ‘control’. ‘Cases’ were cancer patients with chemotherapy induced thrombocytopenia. UPLAT® containing following active ingredients; Carica papaya leaf extract: 350 mg (standardized to 2% flavonoids) and Tinospora cardifolia extract: 150 mg (standardized to 3% bitters) was given twice daily (2 units each) for 10 consecutive days. Platelet count was observed at baseline and day 15 (end of the study). Then pre and post-treatment platelet counts were compared individually in both arms by statistical tests. Response was evaluated in fourty (40) ‘cases’ and twenty ‘control’y.Results: Mean change for platelet count in case group (93990.00±63896.73) was much higher than control group (27600.00±29758.42). No adverse events with the treatment were observed.Conclusions: This study proves the effectiveness of platelet booster UPLAT® (combination of Carica papaya leaf extract and Tinospora cordifolia) as it significantly increased thrombocytes/platelet count in post-chemotherapy cancer patients. 
      PubDate: 2018-10-24
      DOI: 10.18203/2349-3259.ijct20183376
      Issue No: Vol. 5, No. 4 (2018)
       
  • Promoting independence in dementia: protocol for a feasibility trial of
           the PRIDE intervention for living well with dementia

    • Authors: Emese Csipke, Lauren Yates, Esme Moniz Cook, Phuong Leung, Georgina Charlesworth, Holly Walton, Linda Birt, Martin Orrell
      Pages: 177 - 185
      Abstract: Background: Dementia can lead to social exclusion, loss of identity and independence, due to deterioration in cognition and activities of daily living. The aim of the study is to investigate the feasibility of the Promoting Independence in Dementia (PRIDE) intervention, designed to facilitate independence in people with mild dementia.Methods: This is a mixed-methods feasibility trial of the PRIDE, in preparation for a future randomised controlled trial. Up to 50 people with dementia will be recruited. Demetia advisors will deliver the three session intervention. Quantitative outcomes will be taken at baseline and up to three months post baseline. Fidelity checklists will assess fidelity to the intervention. Qualitative implementation data will be gathered in a series of post-intervention semi-structured interviews with staff and participants. This will include data to examine participant experiences of and engagement with the intervention, and other aspects of delivery such as recruitment of DAWs, fidelity and experiences of receiving and delivering the intervention. This study aims to establish and field test the PRIDE intervention; determine the recruitment rate of sites, providers and participants; assess fidelity in delivery of the intervention and engagement with people with dementia; assess the feasibility and acceptability of outcome measure data and assess the acceptability of the intervention by stakeholders.Conclusions: There has been increased need for non-pharmacological interventions for mild dementia. The results of this feasibility study will allow us to plan for a definitive RCT of a three session dementia advisor led intervention for mild dementia.
      PubDate: 2018-10-24
      DOI: 10.18203/2349-3259.ijct20184399
      Issue No: Vol. 5, No. 4 (2018)
       
  • Determinants of performance measures of clinical trials: a study of Indian
           medical devices industry

    • Authors: Naga Rekha Gorantla, Bala Subrahmanya Mungila Hillemane
      Pages: 186 - 193
      Abstract: Developing new medical devices require extensive clinical investigations to enter the market successfully. In recent years, India has emerged as one of the attractive and most preferred countries to carry out clinical trials, primarily due to diverse human gene pool and cost-competitiveness. However, unlike other healthcare products such as therapeutic drugs, there is a lack of regulations over usage of medical devices. Moreover, prior systematic empirical analysis that examine the medical device based clinical trials is also not well established. This study attempted to ascertain the determinants of participant recruitment, selection of locations and time taken to conduct medical device clinical trials. Medical devices that are clinically tested in India in the period of 2008 to 2014 were obtained from CTRI website. 108 out of 279 records were identified as medical device clinical trial registrations. Collected data was analyzed to know the device type, disease category, sponsors involved, participant enrolment, locations and the duration of the device trial. In this study, the category of sponsorship, device type and disease category were found to have significant influence with respect to the selection of number of participants, locations and the time taken to execute medical device clinical trials.
      PubDate: 2018-10-24
      DOI: 10.18203/2349-3259.ijct20184400
      Issue No: Vol. 5, No. 4 (2018)
       
  • Challenges of conducting clinical trials in Asia

    • Authors: Sheraz Ali, Oluwaseun Egunsola, Zaheer Ud Din Babar, Syed Shahzad Hasan
      Pages: 194 - 199
      Abstract: Unlike North America and European Union (EU), Asian continent appears to be an ideal destination for conducting cost-effective clinical trials utilizing the pool of treatment naïve subjects. With a population approaching 4.5 billion, recruitment of subjects can be done without a fear of limited patient pool across Asia. The burden of infectious and chronic diseases is also higher in Asian countries. The emerging clinical trial markets particularly China, South Korea, and Taiwan offers genetic diversity in population group, thus promoting the quality and generalizability of clinical trial’s data. Nonetheless, several challenges also exist for the Western sponsors in majority of the Asian countries; regulatory, operational and infrastructural challenges are at the forefront. Challenges under the heads regulatory, operational, infrastructural, language and cultural, ethics, and future challenges have been discussed. SWOT analysis of Asian clinical trial’s market exhibits enormous opportunities for study sponsors with manageable threats.
      PubDate: 2018-10-24
      DOI: 10.18203/2349-3259.ijct20183748
      Issue No: Vol. 5, No. 4 (2018)
       
 
 
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