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: 4)
Intl. J. of Basic & Clinical Pharmacology     Open Access   (Followers: 3)
Intl. J. of Clinical Trials     Open Access   (Followers: 5)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 8)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 9)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access   (Followers: 1)
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 16)
Intl. J. of Research in Dermatology     Open Access   (Followers: 1)
Intl. J. of Research in Medical Sciences     Open Access   (Followers: 7)
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: 5  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • The effect of troponin values on prognosis in acute pulmonary embolism

    • Authors: Gulay Dasdemir Ilkhan, Hakan Celikhisar
      Pages: 229 - 234
      Abstract: Background: The objective of this study is to evaluate the clinical usefulness of cardiac troponin levels in acute pulmonary thromboembolism (PTE) prognosis.Methods: Thorax computed tomography (CT) angiography was performed and reported by the radiologist as pulmonary embolism and 193 patients older than 18 years of age who were considered PTE by the physician of chest diseases were included in the study. Patients diagnosed with PTE were divided into two groups as those who died within 30 days and did not die within 30 days. As a result of the statistically significant relationship between troponin and mortality, receiver operating characteristic (ROC) analysis was performed to determine the prognosis level of troponin and appropriate sensitivity and specificity cut-off values were determined.Results: We determined that troponin levels of patients diagnosed with PTE in the emergency department were statistically significantly higher in the group with mortality (p=0.031). Since the area under the curve (AUC) value was calculated as 0.636, troponin value was found to have a weak-medium significance in terms of predicting 30-day mortality.Conclusions: Troponin values are statistically significantly higher in patients with a one-month period than the survivor group in this period. However, we concluded that troponin values are not clinically usable as mortality markers due to their low sensitivity and specificity rates. However, due to its significant relationship with increased mortality, patients with PTE with high troponin values should be hospitalized and monitored closely.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204479
      Issue No: Vol. 7, No. 4 (2020)
       
  • Challenges faced by investigators in conduct of oncology trials during
           COVID-19 pandemic at Tata Memorial Centre: a cross-sectional survey

    • Authors: Devanshi Kalra, Abhidnya Desai, Amit Joshi, Gouri Pantvaidya
      Pages: 235 - 244
      Abstract: Background: Novel corona virus disease 2019 (COVID-19) pandemic has impacted health care sector adversely and its major impact is seen especially in the field of oncology. One of the areas of cancer care that has been affected is the conduct of clinical trials. Various challenges have emerged in front of the investigators in providing proper treatment and care to the research participants and moreover in safeguarding the rights, safety and well-being of the research participants.Methods: A questionnaire survey was conducted among the oncologists from the major specialties (medical, surgical and radiation) during the lockdown period to assess the challenges faced in conduct of clinical trials during this pandemic.Results: A total of 110 questionnaires were circulated. Of the 110 questionnaires distributed at the Tata Memorial Centre, 50 responded. The overall response rate was 45.45% (50 responses). Majority of investigators (96%) reported that the pandemic affected the initiation of new trials in oncology. 86% investigators reported that COVID-19 situation has resulted in more protocol deviations than usual for ongoing trials also 62% investigators expressed that the quality of the trial data may get affected due to pandemic.Conclusion: Our survey reports that the majority of the researchers are encountering major challenges in conducting clinical trials in an oncology setting during this pandemic. Despite these challenges in trial conduct, efforts are being made by the investigators and their team to adapt to the new methods for effective management of patients in clinical trials.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204480
      Issue No: Vol. 7, No. 4 (2020)
       
  • Clinical profile and outcomes of acute kidney injury patients in an
           intensive care unit in India

    • Authors: Vivek S. Narayan Pillai, C. Joe Varghese, Christopher C. Pais, Vijay Gopal Rai, Mahabala Chakrapani
      Pages: 245 - 249
      Abstract: Background: The limited epidemiological and outcome data of acute kidney injury (AKI) is available in developing countries. The current single-center study determined the clinical profile of AKI by attempting to identify the presenting symptoms, etiologies, treatment modalities, and disease prognosis in patients admitted in intensive care unit at a tertiary care center in Mangalore, India.Methods: This retrospective study enrolled 70 AKI patients between October 2001 and October 2003, admitted at Wenlock district hospital, Mangalore, KMC hospital Attawar, Mangalore and KMC hospital, Jyothi circle, Mangalore, having a serum creatinine level greater than 1.4 mg/dl and blood urea greater than 53 mg/dl.Results: Amongst the enrolled patients, 45.7% of patients were 40-60 years old and 49 were males with no significant (p=0.412) gender difference. The most common presenting symptom was diminished micturition present in 47.1% of patients and the most common etiology of AKI was sepsis found in 27.1% of patients with the highest (17.1%) mortality. Amongst the patients who underwent conservative treatment (n=52) the mortality rate was 42.8%, while in those who underwent hemodialysis (n=18) the mortality rate was 4.2%. The overall survival rate in the study was 52.9%.Conclusions: The epidemiological data obtained in this study is similar to the previous studies in India with hemodialysis appearing to have better disease outcomes compared to conservative therapy.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204481
      Issue No: Vol. 7, No. 4 (2020)
       
  • Evaluation of variability of electric pulp response threshold in molars:
           an in vivo study

    • Authors: Mujahid Ahmed, Veeresh Tegginmani, Deepu Patil, Zubair Ahmed, Nisar Ahmed
      Pages: 250 - 254
      Abstract: Background: Electric pulp testers are widely used diagnostic tools in endodontics. Several factors can affect the result of electric pulp test like thickness of enamel and dentin, concentration of sensory fibres (A delta fibres), direction of dentinal tubules, pulp chamber size, neural elements etc. There are very few studies available in the literature which evaluated the variability of electric pulp response in molar teeth, which are more susceptible to caries. Hence aim of current study was proposed to evaluate response threshold in molars with respect to age and sex using electric pulp tester.Methods: Fifty volunteers aged between 20 to 69 years were recruited. The human subjects were divided into 5 groups of 10 each (5 males and 5 females) based on age. EPT was used with appropriate electrolyte as a conducting media. Seven sites on each molar crown were tested which includes mesiobuccal cusp tip, mesiobuccal cuspal surface, mesiobuccal gingival surface, centre of the supporting cusps (palatal of maxillary molar and buccal of mandibular molar), distobuccal cuspal surface, distobuccal gingival surface and centre of the guiding cusps (buccal of maxillary molar and lingual of mandibular molars). Statistical analysed using descriptive statistics and independent sample t test.Results: Mesiobuccal cusp tip showed lower response threshold values compared to other sites in all the groups. group 1 responded at lower threshold and group 5 at higher.Conclusions: The optimum electrode placement site for electric pulp test in molars is the mesiobuccal cusp tip irrespective of age and sex.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204482
      Issue No: Vol. 7, No. 4 (2020)
       
  • The South African macular oedema in diabetics study (the same study): a
           prospective randomized non-inferiority trial

    • Authors: Naseer Ally, Sarah Ismail, Bongi P. Sithole, Mpho Tsimanyane, Ismail Mayet, Tebogo R. Kgarebe, Angelika U. Carey, Taimeia G. Hussain, Craig D. Anderson, Kihagi Mwita, Kashmira Rawjee, Monique D.G. Camacho, Melody W.L. Sun, Thabiso Mofokeng, Fathima Mitha, Lintle Ntlou, Ingrid Walters, Hester Kruger, Farai N. F. Mabunda, Lieschen Branders, Ismail Makda, Wihan de Jager, Hassan D. Alli
      Pages: 255 - 261
      Abstract: Background: Diabetic retinopathy is the most common cause of visual loss affecting the economically productive age group globally. Diabetic macular oedema (DMO) results from leakage of fluid into the retinal interstitial space. Anti-vascular endothelial growth factor (anti-VEGF) drugs are the first line treatment for DMO. Since monthly injections are required, this treatment regimen can prove very costly. Of the anti-VEGF drugs, bevacizumab is the most cost-effective. The pro re nata (PRN) method is the current standard of care. However, the treat and extend (T and E) regimen can potentially decrease the patient burden on hospitals. Thus far, no randomised clinical trials have been performed using Bevacizumab in a treat and extend versus pro re nata regimen.Methods: A prospective randomised non-inferiority clinical trial testing bevacizumab (1.25 mg) in a treat and extend method versus the pro re nata method is being conducted. Patients will be randomised using a simple computer-based randomised algorithm. The primary outcome is non-inferiority within a five-letter margin for the T and E regimen versus the PRN regimen.Conclusions: This study aims to inform a key area in the literature on the treatment of DMO, i.e. whether a T and E regimen is non-inferior to a PRN regimen in the treatment of DMO with bevacizumab, which is the only anti VEGF available in resource poor settings. It is motivated by the cost involved in the treatment of DMO as well as the treatment burden on both the patient and the health institution at which the patient is receiving treatment.Trial registration: The trial has been registered on the Pan-African clinical trials registry (PACTR202001624880-753).
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204483
      Issue No: Vol. 7, No. 4 (2020)
       
  • Association of hearing loss in the patients with treated with lamivudine:
           a systematic review protocol

    • Authors: Kalpesh Joshi, Mahesh Belhekar
      Pages: 262 - 270
      Abstract: Background: Hearing loss has been reported with lamivudine therapy. The World Health Organization (WHO) international database of suspected adverse drug reactions (Vigibase) prioritised clinical review of lamivudine and hearing loss in 2015. This manuscript provides the details of research protocol for a systematic review of association of lamivudine with hearing loss.Methods: English-language publications that assess hearing loss within patients who are receiving lamivudine therapy will be included. All study types like clinical trial designs, case-control study, cohort study, retrospective study, case-series or a case report will be included. Preclinical studies, studies enrolling patients with known differential diagnosis such as presbycusis etc will be excluded. Electronic databases (PubMed, Cochrane reviews, Embase and Google scholar), international clinical trials registry, clinicaltrials.gov and pharmaceutical company clinical study registries will be searched for key words related to lamivudine and hearing loss. After a thorough electronic/manual search of manuscript they will undergo a screening process and selected articles will be assessed for risk of bias using online ROBINS-I tool. We will explore outcomes as an observational systematic review.Conclusions: This review will provide detailed benefit-risk analysis of lamivudine with respect to hearing loss in patients with chronic conditions such as Human immunodeficiency virus (HIV) and Hepatitis B virus (HBV) infection.Trial Registration: PROSPERO registration number is CRD42018112205.0.001.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204484
      Issue No: Vol. 7, No. 4 (2020)
       
  • Validation and equivalency of electronic clinical outcomes assessment
           systems

    • Authors: Sarah T. Gary, Antonio V. Otero, Kenneth G. Faulkner, Nadeeka R. Dias
      Pages: 271 - 277
      Abstract: The US food and drug administration (FDA) has long called for clinical outcomes assessments (COA), such as patient-reported outcomes (PRO), to be ‘fit-for-purpose’ meaning the COA has been validated to support the context of use. The FDA’s recent patient-focused drug development guidance series has renewed the importance of ensuring that COA is ‘fit-for-purpose’ and valid.  In addition, the FDA has recommended that COA be collected electronically and that the electronic (eCOA) system and devices also be validated. Advancing technology requires eCOA systems and devices to evolve; eCOA devices may change over time. As bring your own device (BYOD) models gain popularity and acceptance, devices may also be mixed within trials. Changes in eCOA devices or mixing devices may require equivalence testing to prove validity across platforms. The aim of this article is to provide an overview of the different types of validation at both the assessment level and the eCOA system (device) level to help clinical trial sponsors determine the appropriate level of validation or equivalence testing required for COA used in their clinical trials.   
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204485
      Issue No: Vol. 7, No. 4 (2020)
       
  • New drug and clinical trial rules, 2019: an overview

    • Authors: Swathi A. Annapurna, Srinivasa Y. Rao
      Pages: 278 - 284
      Abstract: Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review gives an idea about the recent changes regarding the regulations of clinical trials.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204486
      Issue No: Vol. 7, No. 4 (2020)
       
  • Medical device: a complete overview

    • Authors: Rajganesh Ravichandran, Raveena Pachal Balakrishnan, Jaya Shree Dilli Batcha, Abarna Lakshmi Ravi, Nikhil Cherian Sam
      Pages: 285 - 293
      Abstract: Medical device means any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose. Medical devices are generally classified based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose. Development of an entirely new device typically begins with a concept by a physician or bioengineer for a solution to a medical problem. If the idea is determined to be workable and practical (proof of concept) an early design of the device, known as a prototype, will be built. A prototype device will undergo a cycle of preclinical testing, redesigning, preclinical testing of the redesign and so forth, until the design has been refined and tested to a point that it is ready for production and testing in humans. Preclinical animal tastings are conducted to provide reasonable evidence that novel technologies and therapies are safe and effective. When studying medical devices, clinical trials are not always required, and whether or not one will be conducted depends on a risk assessment. Post marketing surveillance is the practice of monitoring the safety of a medical device after it has been released on the market.
      PubDate: 2020-10-20
      DOI: 10.18203/2349-3259.ijct20204487
      Issue No: Vol. 7, No. 4 (2020)
       
 
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