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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: 12)
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]
  • Tools and processes for tracking IRB approvals as a coordinating center
           for large multicenter clinical research networks

    • Authors: Jenna H. Gabrio, Jeanette Auman, Lindsay Parlberg, Margaret Crawford, Kristin Zaterka-Baxter
      Pages: 1 - 9
      Abstract: Background: Data coordinating centers (DCCs) for multicenter research networks are often responsible for tracking clinical center (CC) IRB approvals. In networks with multiple studies the volume of documentation can be challenging to manage. DCC informatics specialists and coordinators developed simple electronic tools and processes to fulfill this responsibility.Methods: Informatics specialists created a Microsoft Access database to track receipt of IRB approvals from CCs. The database monitors approval expiration dates for an unlimited number of studies and CCs and generates automated reports displaying information on all documented approvals. Coordinators formalized communication procedures for collecting approvals and disseminating information on file. The DCC established a central e-mail account to which CCs submit documentation. The DCC sends monthly e-mails notifying CCs that updated IRB reports have been posted. CCs determine what documentation must be sent to the DCC, and the DCC verifies that all submitted documentation is valid.Results: The database increased DCC efficiencies with a semiautomated mechanism and standardized procedures. New communication processes strengthened compliance with regulatory guidance and client requirements to monitor data collection with appropriate human subjects protections in place. The IRB approval-related e-mail volume sent to CCs was reduced. Automated highlighting of approvals expiring soon reduced DCC coordinator efforts and minimized potential for noncompliance.Conclusions: Although initial investment is needed, formalization of the database and processes result in resource savings throughout the organization’s tenure as a DCC. The flexible nature of access databases makes them an efficient solution for tracking IRB approvals in networks with fluid center compositions.
      PubDate: 2019-01-25
      DOI: 10.18203/2349-3259.ijct20190255
      Issue No: Vol. 6, No. 1 (2019)
       
  • Awareness and attitude of Saudi cancer patients toward participation in
           clinical research

    • Authors: Nagham Sheblaq, Marwan ElBagoury, Ahmed M. Elagouz, Maryam Kotb
      Pages: 10 - 16
      Abstract: Background: Public awareness about the importance of clinical research (CR) is crucial for patient’s participation in clinical trials. Their enrollment may be impacted by their levels of awareness and attitudes toward participation. Our study aimed to assess the Saudi cancer patient’s knowledge and perception about CR, and determine the influencing factors and barriers affecting participation.Methods: A cross-sectional study was conducted in 300 cancer patients attending the Oncology Department at King AbdulAziz Medical City (KAMC) Riyadh between February 2011 and February 2012 using a survey covering the demographic data, knowledge of clinical research, and attitude toward participation; followed by statistical analysis.Results: A total of 300 patients were enrolled in the study with a median age of 53.6 (42.2-64.01); 62.67% of which were females. The majority of patients (97.31%) were not aware of Institutional Review Board (IRB). However, (75.33%) showed interest in CR participation, if offered. The advanced disease (86.67%), and the lack of other treatment options (85.33%) were the top two encouraging factors, while fear of adverse side effects (58.33%), and the unknown efficacy of treatment (58.32%) were the top two barriers against participation. Respondents younger than 45 years, and educated ones were significantly more interested in participation in CR with P values P=0.0136 and P=0.0239 respectively.Conclusions: There is an apparent gap in cancer patient’s awareness about CR. However, there is an obvious interest in participation in CR especially in younger and educated patients. Enhancing public awareness is crucial to improve participation in CR.
      PubDate: 2019-01-25
      DOI: 10.18203/2349-3259.ijct20190256
      Issue No: Vol. 6, No. 1 (2019)
       
  • Evaluation of the efficacy of 150 micrograms of intrathecal morphine with
           bupivacaine compared to 250 micrograms for postoperative analgesia
           following abdominal hysterectomy: a double blinded randomized control
           study

    • Authors: G. S. Sai Ram Prudhvi, N. S. S. Naga Shyam, Anand Acharya
      Pages: 17 - 22
      Abstract: Background: The synergistic action of local anesthetics and morphine is well known, morphine probably more superior for postoperative analgesia, when compared to other opioids. Preservative-free morphine is now available in India making intrathecal administration possible. The present randomized double blind study was designed to evaluate the effect of adding preservative free morphine to hyperbaric bupivacaine given intrathecally for abdominal hysterectomy.Methods: Following approval by the institutional review board and institutional research grant committee, eighty patients presenting for elective abdominal hysterectomy were included in this randomized, double blind study. All drugs used for spinal anesthesia were autoclaved as per the departmental protocol. 3.5 ml of hyperbaric bupivacaine 0.5% [heavy] was given in both groups along with preservative free morphine according to study group.Results: 27.5% (11/40) patients in group A, 17.5% (7/40) patients in group B received one dose of rescue analgesia (ketorolac 10 mg),during the 24 hours for pain relief  while 29 patients is group A (72.5%) and 82.5% (33/40) patients in group B received 2 doses of rescue analgesia. 10% patients in Group A (4/40) and 10% patients in Group B (4/40) had a sedation score of 1 (drowsy and arousable).Conclusions: The mean duration of analgesia in patients who received 250 μgms of intrathecal morphine was 18.725±1.38 hours while in patients who received 150 μgms it is 16.075±1.23 hours. We conclude that 250 µgms of preservative-free intrathecal morphine provides longer duration of analgesia when compared to 150 µgms morphine, with hardly any additional adverse effects.
      PubDate: 2019-01-25
      DOI: 10.18203/2349-3259.ijct20190257
      Issue No: Vol. 6, No. 1 (2019)
       
  • Accelerometer-based facilitated walking program in addition to usual care
           for the management of patients with low back pain at medium or high risk
           of chronicity: a randomised controlled trial protocol

    • Authors: Hosam Alzahrani, Martin Mackey, Emmanuel Stamatakis, Marina B. Pinheiro, Debra Shirley
      Pages: 23 - 32
      Abstract:  Background: The lifetime prevalence of low back pain (LBP) has been reported to be as high as 84% worldwide. Around 23% of the population has chronic non-specific LBP. Despite the potential health benefits of walking, few studies have investigated its effectiveness in people with non-specific LBP. The primary objective is to examine the efficacy of a Fitbit facilitated walking intervention in people with LBP with medium or high risk of chronicity in reducing disability and pain. The secondary objective is to investigate the efficacy of a Fitbit facilitated walking intervention in increasing physical activity levels in people with LBP.Methods: This prospective, randomised controlled trial will involve 68 participants. This study will recruit participants who are aged 18 years or over, have been diagnosed with non-specific LBP with medium or high risk of chronicity and classified as physically inactive. Participants will be randomised into two groups: usual physiotherapy care (n=34) and usual physiotherapy care plus Fitbit facilitated walking intervention program (n=34). The treatment duration will be 8 weeks. Primary outcomes for this study are disability and pain. Secondary outcomes include physical activity level and walking steps, depression, fear of movement and pain catastrophising. The outcomes will be assessed at baseline, post-intervention and 26 weeks post-randomisation follow-up.Conclusions: The results of this study will provide empirical evidence on the efficacy of a Fitbit facilitated walking intervention program, when added to usual care, in a clinical setting for improving disability and pain, and other clinical outcomes in people with LBP.Trial Registration: Australian New Zealand clinical trials registry (Number ACTRN12617001404314).
      PubDate: 2019-01-25
      DOI: 10.18203/2349-3259.ijct20190258
      Issue No: Vol. 6, No. 1 (2019)
       
 
 
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