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

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Intl. J. of Advances in Medicine     Open Access   (Followers: 2)
Intl. J. of Basic & Clinical Pharmacology     Open Access   (Followers: 2)
Intl. J. of Clinical Trials     Open Access   (Followers: 3)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 7)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 8)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access   (Followers: 1)
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 15)
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: 4)
Intl. Surgery J.     Open Access   (Followers: 4)
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International Journal of Clinical Trials
Number of Followers: 3  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • Dry needling is effective in reducing acute pain in patients with severe
           knee osteoarthritis

    • Authors: Amanda Machado Antonio, Thaina Cristina Vieira Gaspardi, Evelyn Regina Couto, Gustavo Constantino de Campos, João Batista de Miranda, Alessandro Rozim Zorzi
      Pages: 154 - 159
      Abstract: Background: The objectives of the study was to evaluate the efficacy of dry needling inactivation of trigger points in acute pain relief and function improvement in patients with severe knee osteoarthritis.Methods: Thirty participants choose between dry needling or static stretching. It was analyzed the immediate effects of a single dry needling intervention, compared to a control group that received static stretching. Outcomes of the study was timed up and go test; visual analogue scale and brief pain inventory.Results: The group treated with dry needling had a better result on the visual analogue scale and on the brief pain inventory scale. There was no difference in time up and go performance in relation to the control group. The muscle group with the highest prevalence of trigger points was the thigh adductors (83.3%), despite valgus or varus frontal plane misalignment of the limb.Conclusions: The inactivation of trigger points by dry needling in patients with acute pain due to severe osteoarthritis of the knees obtained better relief compared to static stretching of the musculature.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203101
      Issue No: Vol. 7, No. 3 (2020)
  • Identifying the gaps in human and veterinary chlamydia vaccine development

    • Authors: Marga Janse, Marcela Trocha, Jelle Fedema, Eric Claassen, Linda Van De Burgwal
      Pages: 160 - 169
      Abstract: Background: Chlamydia infections in humans and animals pose a significant burden on health systems worldwide. While widespread screening, adequate treatment, and prevention programs are helpful to increase awareness and improve screening rates, infection rates are rising. A vaccine is necessary to slow increasing rates, manage negative consequences, and prevent possible antibiotic resistance. We present the current landscape regarding the innovations for commercial vaccine development in a “one-health” context.Methods: We developed a unique dataset containing data of patent documents intended for human and veterinary use, and clinical trials in order to provide a detailed description of the global chlamydia vaccine developments.Results: Analysis of patents and clinical trials intended for human use presented a vaccine field that is underdeveloped, with no commercial human chlamydia vaccine available, and two potential candidates in a phase 1 clinical trial. Comparing innovations concerning chlamydia vaccine developments for both human and veterinary patents, it was clear that these fields are very different and independent of each other. The field is small, and certain companies and researchers show repeated interest. Partnerships among applicants and those involved in chlamydia vaccine innovation would be an important step to take towards innovating and developing an effective vaccine.Conclusions: We have shown that North America is considered, by patent application, to hold the most potential for a chlamydia vaccine, specifically against the Chlamydia trachomatis strain. A new vaccine is likely to be a subunit vaccine with components of the major outer membrane protein antigen.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203102
      Issue No: Vol. 7, No. 3 (2020)
  • Efficacy and safety of Prunus mume and choline in patients with abnormal
           level of liver function test

    • Authors: Muhammad N. Aslam, Anwar Ali, Suresh Kumar
      Pages: 170 - 175
      Abstract: Background: The objectives of the study were to determine the efficacy and safety of Prunus mume and choline in patients with abnormal liver function test.Methods: This open labelled, multi-centered observational study was done for a from May 2019 to December 2019. Patients of either gender, above 18 years of age having elevated levels of aspartate aminotransferase, alanine transaminase or gamma-glutamyltransferase were included in the study after taking informed consent. One to two tablets of revolic per day were given preferably in the morning with breakfast or as per instructions of the physician. Patient follow-ups were done at 2nd and 4th week after treatment. SPSS version 20.0 was used for analysis. Frequency and percentages and for quantitative data, mean, standard deviation, median and interquartile range were recorded. Wilcoxon signed ranks test was applied with p value of <0.05 as significant level.Results: Among 247 patients, male to female ratio was 2:1 with overall mean age of 42.8±12.6 years. Total bilirubin decreased from baseline to week-4 in treatment with Prunus mume extract and choline (p=0.04). Median and IQR of alanine transaminase levels also reduced substantially from 99 (52) to 42 (36.5) I/U. Aspartate aminotransferase levels significantly decreased from 78.5 (57) to 40 (29) I/U. Overall at the end of treatment on week-4, 26 (10.5%) patients experienced gastrointestinal distress, 25 (10.1%) anorexia, 14 (5.7%) excessive salivation and 29 (11.7%) patients experienced excessive sweating.Conclusions: This study reported significant improvement in alanine transaminase and aspartate aminotransferase levels after treatment with Prunus mume extract and choline (revolic). It is safe and effective to use them for deranged liver functions tests.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203103
      Issue No: Vol. 7, No. 3 (2020)
  • Clinical efficacy of different dosage forms containing vitamin D: design
           and study outcomes of a randomized, comparative clinical trial

    • Authors: Nidhi Sapkal, Gaurav Chhaya, Milan Satya, Dhara Shah
      Pages: 176 - 187
      Abstract: Background: Different dosage forms of vitamin D like tablets, soft gelatin capsules, oral granules, powders, solutions and thin films are available. The objective of the present study was to evaluate and compare the clinical efficacy of three different dosage forms of vitamin D3 namely, orally disintegrating strips, oral granules and oral solution.Methods: An open label, single centre, prospective, randomized, parallel group, comparative study was conducted for a period of 4 months. The study participants were divided into three groups (A, B, C) and received the respective treatments (orally disintegrating strips, n=20; granules, n=20; oral nano solution, n=10) for the study period. The estimation of blood levels of 25-hydroxy vitamin D [25(OH)D3] in all the subjects at day 0, 60 and 120 was carried out.Results: The normalization level of 25(OH)D3 achieved by the subjects in group A, group B and group C was 100%, 83.3% and 90% respectively after 90 days. Comparison of 25(OH)D3 level in all three groups showed significant increase at day 60. The levels were maintained at day 90 and 120 even after drastic reduction in dosage in Group A and group C. On day 120, the dose reduction was in the order of group A>group C>group B.Conclusions: All the three formulations showed increase in the level of 25(OH)D3. It can be concluded that oral disintegrating strips of 25(OH)D3 are clinically more efficient than other conventional dosage forms.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203104
      Issue No: Vol. 7, No. 3 (2020)
  • Comparison of the effectiveness between epidural methylprednisolone
           injection and intranasal calcitonin in reduction of back pain due to
           osteoporosis in postmenopausal patients: a randomized controlled trial

    • Authors: Kanti Rajkumari, Akoijam Joy Singh, Longjam Nilachandra Singh
      Pages: 188 - 193
      Abstract: Background: Back pain is a common symptom in osteoporotic patients due to spinal compression fracture. Conservative management like nonsteroidal anti-inflammatory drugs and spinal orthoses has not been able to produce early pain relief. Intranasal calcitonin spray is considered effective because of its analgesic effect and increase in bone density. Role of epidural steroid injection for the treatment of osteoporotic back pain has not been studied. This study was conducted to find out the efficacy of epidural methylprednisolone injection in management of osteoporotic back pain in postmenopausal patients.Methods: Hundred patients with osteoporotic back pain in postmenopausal subjects were allocated into two groups: epidural and calcitonin. Epidural group received a single dose of interlaminar epidural steroid injection with methylprednisolone 80 mg. Calcitonin group received one puff of 200 IU given through one nostril followed to the other nostril the next day. Visual analogue scale for pain was the outcome measurement used. Pain relief at rest within 7 days was taken as early pain relief and within 21days as late pain relief. Pain relief after 21st day was considered no response. Test of significance was done by Kaplan Meier, Chi square and Fisher exact tests.Results: Out of 50 patients, 38 patients in the epidural group got pain relief within 7 days and the finding was statistically significant.Conclusions: Epidural methylprednisolone gives faster pain relief as early as the first post-injection day with a median value of 2 days against 15 days in case of intranasal calcitonin spray.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203105
      Issue No: Vol. 7, No. 3 (2020)
  • A retrospective study: root cause analysis of reported serious adverse
           event and development of corrective action and preventive action for
           deviated serious adverse event reports at a clinical trial site management

    • Authors: Dayanand Raddi, Revena S. Deveriniti, M. S. Ganachari, Geetanjali Salimath
      Pages: 194 - 199
      Abstract: Background: Serious adverse events (SAEs) are preventable if reported on time. Assessment of harm caused by clinical trials is difficult than assessing the benefits as it relied on the information as recorded by the study team. Hence it is important to have knowledge about quality safety reporting. The objectives of the study were to assess root cause for the timeline deviation found in SAE report and to develop the corrective action and preventive action to minimize deviation rate.Methods: A retrospective study was conducted in KLE’s Hospital and MRC, Belagavi. Data was collected from SAE documented trial study files. Between August 2016 to August 2019, 25 SAE occurred during clinical trials which were included in the study through complete enumeration and purposive sampling.Results: Data was analyzed for SAE reporting timeline where in no deviation was found in initial report. It was seen that all SAEs were not related to investigational product. The narrations of SAE were according to standardized format as per Ethics Committee review report. A gap was observed between onset of SAE and initial report in 16 case reports.Conclusions: The study concluded that there was a lag in reporting from onset of SAE to initial report even though there was no deviation observed in the initial report timeline. The main contributing factors were admitting in different hospital without information and lack of knowledge by subjects or their relatives which shows the need of awareness about quality safety reporting.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203106
      Issue No: Vol. 7, No. 3 (2020)
  • Evaluation of the feasibility and effectiveness of a health facility-based
           combined with home-based early childhood development intervention in Siaya
           County, Kenya: a cluster-randomized control trial

    • Authors: Patricia Kitsao-Wekulo, Hermann P. P. Domfouet, Silas Onyango, Milka Wanjohi, Debjeet Sen, Matthew Frey, Loida Erhard, Ranju Baral, Christopher Obong'o, Oscar Kadenge, Beatrice Oyugi, Rachel Kavithe, Dickens Omedo, Amina Abubakar, Teresa Mwoma, Stewart Kabaka, Mark Tomlinson, Linda Richter, Cyril Engmann, Elizabeth Kimani-Murage
      Pages: 200 - 211
      Abstract: Background: Approximately 250 million (43%) children under five years in low- and middle-income countries are at risk of sub-optimal development. Of these, 67% are found in sub-Saharan Africa due to exposure to multiple risks, including inadequate stimulation at home. In order to promote early childhood development (ECD), an intervention integrating ECD content into routine facility-based health services and supporting ECD policy and advocacy is currently being implemented in Siaya County. In addition, parental counseling on early stimulation is integrated into home-based visits by community health volunteers. We aim to evaluate the intervention’s operational feasibility, effectiveness and cost-effectiveness.Methods: The study is a cluster-randomized controlled trial using a mixed-methods approach. The study is being conducted in Bondo sub-county in Siaya County. The study has three arms. Arm 1 will receive a health facility-based ECD intervention. Arm 2 will receive the health facility-based ECD intervention combined with home-based ECD counselling. Arm 3 (control) will receive standard care. Six health facilities in each study arm (18 in total) will be randomly selected from wards within the sub-county. We aim to recruit and follow-up 699 mother/caregiver-child dyads, 233 in each arm. Pregnant women are recruited when they visit health facilities during the third trimester. Analysis will involve estimating the effect of the intervention using mixed linear models and the Difference-in-Differences estimator.Conclusions: The data generated from this study will provide much-needed information for program design and implementation of interventions aimed at promoting ECD in Kenya and other sub-Saharan African countries.Trial Registration: Current Control Trial is ISRCTN11561283. 
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203107
      Issue No: Vol. 7, No. 3 (2020)
  • A systemic review of clinical trials of COVID-19, registered in WHO-ICTRP

    • Authors: Suyog Vyas, Kartiki S. Vyas
      Pages: 212 - 220
      Abstract: In September 2004, International Commission of Medical Journal Editors implemented a dramatic and important policy for the condition of publication of clinical trials. The condition was that clinical trials must be registered in a public trial registry. World Health Organization-International Clinical Trials Registry Platform (WHO-ICTRP) is the globally centralised network composed of primary registries and partner registries along with data providers. COVID-19 is a pandemic and a significant social and economical health burden. In this event numbers of trials have been undertaken by the medical professionals and research workers in every part of the world. Here we have analysed registered clinical trials for the detection, treatment and prevention of COVID-19 to provide a summary of global response WHO-ITCRP. The objective of this study was to collect the data of registered clinical trials for the therapeutic and preventive measures for COVID-19 which are registered in WHO-ICTRP and analyse global response of COVID-19. WHO-ITCRP database has 20 fields of mapping. Out of these, we have analysed 6 fields of this registry, for this study purpose: public title, scientific title, study type, countries, intervention and primary outcome. Clinical trials are focused on chloroquine, hydroxychloroquine, lopinavir ritonavir combination, Remdesivir, Favipiravir, Tocilizumab and Interferon. Also, it is seen that convalescent plasma therapy is a promising intervention. Observational trials are directed mainly on the clinical features and distinguish COVID-19 from other influenza like illnesses.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203108
      Issue No: Vol. 7, No. 3 (2020)
  • Future of risk based monitoring in clinical trials

    • Authors: Niraj R. Vyas
      Pages: 221 - 228
      Abstract: Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.
      PubDate: 2020-07-21
      DOI: 10.18203/2349-3259.ijct20203109
      Issue No: Vol. 7, No. 3 (2020)
School of Mathematical and Computer Sciences
Heriot-Watt University
Edinburgh, EH14 4AS, UK
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