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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: 3)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 5)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 5)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access  
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 13)
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: 3)
Intl. Surgery J.     Open Access   (Followers: 1)
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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]
  • Measurement of equivalence using a patient-reported daily pain diary
           across three smartphone devices

    • Authors: Elisa Conrad, Sarah Gary, Laura Khurana, Tony Otero, Jenny Ly, Susan Dallabrida
      Pages: 154 - 160
      Abstract: Background: Patient-reported outcomes play an essential role in evaluating the results of clinical trials. As technological advances are made throughout the industry, pharmaceutical sponsors’ ability to collect field-based patient data has greatly increased. Recently, many clinical trials are utilizing varying modes of data capture in order to enable maximum flexibility. Given the regulatory concern over the equivalence of mixed modes of administration, the need to research the use of varying devices is essential.Methods: This study reviewed three handheld smartphone devices for conceptual equivalence and conducted usability for standard questions used in a daily pain diary. Ten participants, 7 females 3 males; ages 27-70 years, diagnosed with chronic pain or fibromyalgia, completed the same pain diary on three different smartphone devices.Results: Overall, participants reported no differences between these three smartphone devices and found the presentation of the diary content to be similar, if not identical, on all three devices.Conclusions: Device type had no impact on the presentation of the diary content or participants’ understanding of the diary questions.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20194578
      Issue No: Vol. 6, No. 4 (2019)
       
  • Three point fixation is superior to two point fixation technique for
           zygomatic complex fracture

    • Authors: Gul Zaman, Muhammad Azeem Khan, Muhammad Zeshan Hyder, Taimur ul Hassan, Afifa Zafar, Waleed Ashraf, Muhammad Kashif
      Pages: 161 - 166
      Abstract: Background: Isolated zygomatic or malar bone fractures are second most common fracture among facial skeletal injuries. It has been reported that three point fixation is appropriate for isolated zygomatic bone fracture. The objective of current study was to compare the mean difference in terms of malar height outcome by using different fixation techniques (two point and three point) in patients with zygomatic complex fracture.Methods: This randomized controlled trial was conducted at Department of Oral and Maxillofacial Surgery, MMDC, Multan, during a period of six months from 1st June 2017 to 30th November 2017. A total 182 patients of both genders were included in this study. Two point fixation techniques were used in Group-A patients. While 3 point fixation was used in Group-B patients. After 6 weeks follow-up, patients were assessed for malar height. Outcome was measured by comparing the mean difference of pre and postoperative malar height of both techniques. Data were analyzed using computer program SPSS-21. P≤0.05 was taken as significant in all analysis.Results: Among patients in two point fixation group, the mean malar height was 67.55±2.98 mm and in three point fixation group, means malar height was 71.55±2.36 mm. The difference of malar height among two treatments was highly significant with p<0.01.Conclusions: Using three point fixation results better as compared to two point fixations in terms of malar height outcome.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20193618
      Issue No: Vol. 6, No. 4 (2019)
       
  • Comparative feasibility of two World Health Organization partographs to
           predict prolonged labour: a randomized control trial

    • Authors: Mohini Rajoriya, Ruchi Kalra
      Pages: 167 - 174
      Abstract: Background: One of the major causes of maternal mortality is obstructed labor. Identification of abnormal labor at earliest and timely management can prevent prolonged labor and significantly reduce its sequel. Partograph is a useful tool in hands of labor care givers to monitor labor course. The study was done to compare feasibility of two WHO partographs a composite partograph including the latent phase with a simplified one without the latent phase to predict prolonged labor in randomized control trial.Methods: A randomized controlled trial, with parallel arm design was conducted. Sample size was calculated as 404 pregnant women .They were randomly categorized in two groups, each group having 202 participants.Results: labor had crossed the alert line in 108 (53.4%) cases monitored by composite partograph and 38(18.8%) cases monitored with simplified partograph. The calculated P value was <0.0001. The odds ratio calculate was 4.95 and 95% confidence interval was 3.16 to 7.76. Labor crossing the action line was found in 16 (7.9%) in composite partograph whereas in simplified partograph, labor had crossed the action line in 18 cases in simplified group. Calculated P value was 0.72 (>0.05). The odds ratio was 0.8793 and 95% confidence interval 0.43 to 1.77 which was not significant statistically .Most participants (70%) experienced difficulty with the composite partograph, but no participant reported difficulty while plotting the simplified partograph.Conclusions: WHO simplified partograph was found to be as good as WHO composite partograph in identifying maternal and perinatal outcomes and was more user friendly.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20193674
      Issue No: Vol. 6, No. 4 (2019)
       
  • Challenges and threats of investigator-initiated multicenter randomized
           controlled trials: the BACE trial experience

    • Authors: Kristina Vermeersch, Bénédicte Demeyere, Karen Denaux, Katelijne De Nys, Thierry Troosters, Guy G. Brusselle, Wim Janssens
      Pages: 175 - 184
      Abstract: Background: Investigator-initiated clinical research has become a complex environment. Increasing administrative tasks and costs, imposed by stringent regulatory demands, risk to reduce this creative, independent and indispensable research field. The objective of the present study was to illustrate the burden of non-scientific challenges associated with an investigator-initiated multicentre randomized controlled trial, based on the Belgian trial with azithromycin for Chronic obstructive pulmonary disease (COPD) Exacerbations requiring hospitalization (BACE) trial experience.Methods: The trial enrolled 301 patients with COPD, hospitalized for an acute exacerbation between 2014-2017, and assessed the potential of azithromycin, an off-patent antibiotic. Key experienced challenges were complemented with registry data from the Clinical Trial Centre of the University Hospital Leuven to outline the local clinical respiratory research field, quotations for the trial protocol obtained from 3 pharmaceutical companies to provide insight into the budget restraints and a participation survey to capture the consortium’s perspective.Results: 60% of the required sample size was enrolled. Key challenges included trial implementation, study drug and database management. Industry-initiated trials dominated the local research field (61%), whereas investigator-initiated prospective interventional and multicenter trials accounted for 19% and 13%, respectively. The triple quotation revealed the BACE trial to require 1.6 to 2.1-fold the amount when executed by the pharmaceutical industry. The survey identified the lack of a local study team as an important obstacle for participation, along with inadequate financial compensation and excessive administrative workload.Conclusions: Without an adaptation of current regulatory and funding policies to overcome non-scientific challenges, investigator-initiated clinical research is risking to further decline.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20194652
      Issue No: Vol. 6, No. 4 (2019)
       
  • Comparison of standard and tubeless percutaneous nephrolithotomy for renal
           calculi: a prospective randomized control trial

    • Authors: Manu Muraleedharan Kamalakshi, Vasantharaja Ramasamy, Darsan Sadasivan, Sunil Raveendran, Selvam Paramasivam, Venugopal Ganapathy
      Pages: 185 - 190
      Abstract: Background: In the current era of minimally invasive interventions, the mainstay of treatment of renal stones larger than 2 cm is Percutaneous nephrolithotomy (PCNL). PCNL underwent various evolutionary changes minimizing morbidity to the patients. We prospectively compared the outcome of tubeless PCNL (without nephrostomy drainage tube) to reduce the pain and discomfort caused by tube with standard PCNL in the treatment of renal stones.Methods: In this Randomized control trial (RCT), we divided patients satisfying the inclusion criteria of consenting for trial, single access puncture, less than 3 stones each less than 3 cm, operative duration of less than 2 hours into two groups, standard PCNL (group 1) and tubeless PCNL (group 2) with 25 patients each. Randomization and group assignment were done after complete clearance of renal stones.Results: Patient’s age, gender, sides of stone and stone size were comparable between two groups (standard versus tubeless PCNL). Postoperative hemoglobin drop, bleeding, pyrexia, urine leak, and blood transfusion requirement did not show a statistically significant difference between the two groups. Analgesic requirement (190 mg versus 80 mg of tramadol), operative duration (49.80 min versus 38.60 min), postoperative pain score (6/10 versus 3.64/10-visual analog scale) and duration of hospital stay (68.48 hours versus 41.12 hours) showed statistically significant difference favoring tubeless PCNL.Conclusions: Tubeless PCNL may be a safe, acceptable and effective modality of treatment for renal calculi in carefully selected patients comparing standard PCNL resulting in less operative duration, lower postoperative pain, reduced analgesic requirement and shorter hospital stay.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20194653
      Issue No: Vol. 6, No. 4 (2019)
       
  • A simple screening tool to identify women with previously undiagnosed
           prediabetes and diabetes mellitus in the community

    • Authors: Indu Waidyatilaka, Pulani Lanerolle, Sunethra Atukorala, Rajitha Wickremasinghe, Noel Somasundaram, Angela de Silva
      Pages: 191 - 197
      Abstract: Background: In the current context of rising prevalence of non-communicable diseases (NCD), simple low-cost screening tools are essential for identifying individuals who have glucose dysregulation at its early stages. Therefore, we developed and validated a screening tool for dysglycemia (defined as HbA1c≥5.7%) with the potential to identify undiagnosed prediabetes and as well as diabetes mellitus.Methods: A sample of 2800 women representative of Colombo Municipal Council area was screened using fasting blood glucose for dysglycemia. All (n=272) newly diagnosed dysglycemics and a further 345 normoglycemics were recruited following confirmation of glycemic status by HbA1c, to enable ROC analysis. A pretested questionnaire and the International physical activity questionnaire (IPAQ) validated for Sri Lanka were used to generate variables for the risk score.Results: A risk score for dysglycemia with a sensitivity of 87% and specificity of 87% and AUC of 0.941 was developed with two common symptoms of dysglycaemia, history of recent increase in frequency of passing urine and recent reduction in vision, one common food related practice, inability to resist sugary food and one indicator of sedentary behavior, TV viewing time and a single anthropometric measurement, waist circumference.Conclusions: A tool to identify prediabetes is currently unavailable and this new tool fills this gap. Further, the tool is designed to include women with previously undiagnosed diabetes mellitus. Inclusion of lifestyle parameters having a known association with dysglycemia increased the strength of the tool. Early identification will ensure targeting of interventions at the point of maximum effect.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20194654
      Issue No: Vol. 6, No. 4 (2019)
       
  • Feasibility of acceptance and commitment therapy for post-bariatric
           surgery patients: the FAB study protocol

    • Authors: Lisa Cotter, Samantha Scholtz, Shikta Das, John Tayu Lee, Dayna Lee-Baggley, Elizabeth A. Barley
      Pages: 198 - 205
      Abstract: Background: Bariatric surgery is an effective treatment for obesity. However, around one in five people experience significant weight regain. In the months following surgery, loss of food as a hedonic reward, increased sensitivity to food-related cues, alcohol use and depression may translate into new obesogenic behaviours which can be targeted in therapy. Acceptance and Commitment Therapy (ACT) teaches acceptance of and defusion from thoughts and feelings which influence behaviour, and commitment to act in line with personal values. We will test whether people who have had bariatric surgery over one year ago find 10 weeks of ACT group therapy an acceptable treatment and whether a larger trial to test whether ACT can improve long-term post-operative outcomes would be feasible.Methods: This will be a feasibility randomised controlled trial (RCT) with participants randomised to either ACT or a Usual Care Support Group control. Participants will be recruited at 15-18 months post-surgery and compared at baseline, 3, 6 and 12 months. The trial will provide information about recruitment and characteristics of the proposed outcome measures to inform a definitive RCT.Conclusions: Trials big enough to determine whether a treatment approach works are costly, so this small study will help determine whether the methods used, such as how people are recruited, allocated to groups, and how data are collected, are likely to work on a bigger scale. This project is the first step in testing whether ACT can help people who have had bariatric surgery.Trial Registration: Researchregistry.com, UIN: 3959 (date registered: 10 April 2018); ISRCTN registry ID: ISRCTN52074801.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20194655
      Issue No: Vol. 6, No. 4 (2019)
       
  • Effectiveness of modified Whitfield’s ointment with oral griseofulvin in
           the treatment of dermatophytosis poorly responsive to standard antifungal
           therapy: a randomized, double blind, within patient placebo control

    • Authors: Sanjeewani Fonseka, Brabaharan Subhani, P. Vitharana Ranjith Kumarasiri
      Pages: 206 - 214
      Abstract: Background: Dermatophytosis is a superficial fungal infection found in hot and humid areas particularly in tropical regions and affects the keratinized regions of the body. It is usually treated with a combination of topical and systemic antifungal therapy as well as improved hygienic measures. Over the last few decades there has been an increase in the prevalence of dermatophyte infections which are poorly responding to standard antifungal therapy.Methods: Modified Whitfield’s ointment is a combination of 5%-5% Salicylic acid and Benzoic acid with an emulsifying ointment as a vehicle which has both a fungistatic and a keratolytic action. Oral Griseofulvin is a systemic antifungal agent which is a fungistatic agent. The combination of the above agents is synergistic. A randomized double blind, within-patient-placebo-controlled trial was designed for the treatment of dermatophytosis poorly responsive to standard antifungal therapy.Conclusions: This may shed light on the treatment of dermatophytosis poorly responsive to standard antifungal therapy.Trial Registration: This trial is registered with WHO trial registry number (Universal trial number): U111-1235-8791. 
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20194656
      Issue No: Vol. 6, No. 4 (2019)
       
  • A prospective study to evaluate pelvic bone mineral density changes in
           patients of cervical cancer undergoing chemoradiotherapy: study protocol

    • Authors: Divyesh Kumar, Tulika Singh, Pooja Bansal, Bhavana Rai
      Pages: 215 - 218
      Abstract: Background: Cancer treatment induced bone loss has been retrospectively studied as a distinct entity in gynaecological cancers. Amongst gynaecological cancers, cervical cancer is the leading cause of mortality and morbidity, majorly in developing countries. Concurrent chemoradiation (CCRT) is considered as the standard of care in managing these patients. Persistent low back ache is often reported as a potential post treatment sequalae by long term survivors of cervical malignancy. Various retrospective studies done have observed reduced density and osteopenia of the bones in the irradiated area, as a possible etiologic factor for persistent low back ache.Methods: We in this prospective clinical trial propose to prospectively and systematically evaluate the changes in pelvic bone density in patients of cervical cancer receiving chemoradiotherapy using dual energy X-ray absorptiometry (DEXA) scan done pre and post treatment, and correlate the changes with occurrence and severity of persistent low back ache. Low back ache will be evaluated using Oswestry low back pain disability scale, scoring for which shall be done pre-treatment and then at post treatment at 2 monthly interval for 1 year on follow up.Conclusions: Results from the trial might bring-forth the changes in the density of pelvic bones in patients of cancer cervix undergoing concurrent chemoradiation and its correlation with low back ache, if any.Trial Registration: This trial is registered with number CTRI/2017/05/008606.
      PubDate: 2019-10-19
      DOI: 10.18203/2349-3259.ijct20193661
      Issue No: Vol. 6, No. 4 (2019)
       
 
 
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