International Journal of Clinical Trials 2023-04-26T14:19:25+00:00 Editor Open Journal Systems <p>International Journal of Clinical Trials (IJCT) is an open access, international, peer-reviewed journal that encompasses all aspects of clinical trials. The journal's full text is available online at The journal allows free access to its contents, offers a way to make data both freely available and highly visible worldwide; this will benefit the impact of your publication. International Journal of Clinical Trials is dedicated to publishing articles on clinical trial methodology as well as protocols, commentaries and results papers. International Journal of Clinical Trials (IJCT) is one of the fastest communication journals and articles are published online within short time after acceptance of manuscripts, this will benefit the societies by getting faster access to your clinical trial results. The journal has a broad coverage for articles are clinical trial methodology, traditional results papers, regulatory aspects of clinical trial, research ethics, clinical trial management, clinical data management and biostatistics. The journal has unrestricted space and takes advantage of all the technical possibilities available for electronic publishing. It is published quarterly and available in print and online version. International Journal of Clinical Trials (IJCT) complies with the uniform requirements for manuscripts submitted to biomedical journals, issued by the International Committee for Medical Journal Editors.</p> <p><strong>Issues: 4 per year</strong></p> <p><strong>Email:</strong> <a href="" target="_blank" rel="noopener"></a>, <a href="" target="_blank" rel="noopener"></a></p> <p><strong>Print ISSN:</strong> 2349-3240</p> <p><strong>Online ISSN:</strong> 2349-3259</p> <p><strong>Publisher:</strong> <a href="" target="_blank" rel="noopener"><strong>Medip Academy</strong></a></p> <p><strong>DOI prefix: 10.18203</strong></p> <p>Medip Academy is a member of Publishers International Linking Association, Inc. (PILA), which operates <a href="" target="_blank" rel="noopener">CrossRef (DOI)</a></p> <p> </p> <p><strong>Manuscript Submission</strong></p> <p>International Journal of Clinical Trials accepts manuscript submissions through <a href="" target="_blank" rel="noopener">Online Submissions</a>:</p> <p>About the Journal &gt; <a title="Online Submissions" href="" target="_blank" rel="noopener">Online Submissions</a></p> <p>Registration and login are required to submit items online and to check the status of current submissions.</p> <p>If you find any difficulty in online submission of your manuscript, please contact editor at <a href=""></a></p> <p> </p> <p><strong>Abbreviation</strong></p> <p>The correct abbreviation for abstracting and indexing purposes is Int J Clin Trials.</p> <p> </p> <p><strong>Abstracting and Indexing information</strong></p> <p>The journal is indexed with </p> <p><a href="[Title+Abbreviation]" target="_blank" rel="noopener">PubMed and PubMed Central (PMC) (NLM ID: 101724850, Selected citations only)</a>, </p> <p><a title="Scilit (MDPI)" href="" target="_blank" rel="noopener">Scilit (MDPI)</a>, </p> <p><a href="" target="_blank" rel="noopener">Index Medicus for South-East Asia Region</a> (WHO),</p> <p><a href=";subAction=hits&amp;journalID=31976&amp;userQueryID=32086&amp;high=1&amp;ps=30&amp;page=1&amp;items=0&amp;journal_filter=&amp;journalby=" target="_blank" rel="noopener">JournalTOCs</a>,</p> <p><a href=";journalId=31395" target="_blank" rel="noopener">Index Copernicus</a>,</p> <p><a href="" target="_blank" rel="noopener">CrossRef</a>,</p> <p><a href="" target="_blank" rel="noopener">Index Scholar</a>,</p> <p><a href="" target="_blank" rel="noopener">Journal Index</a>,</p> <p><a href="" target="_blank" rel="noopener">Google Scholar</a>,</p> <p><a href="" target="_blank" rel="noopener">J-Gate</a>,</p> <p>Directory of Science,</p> <p><a href=";issn=23493240&amp;uid=rdeac3" target="_blank" rel="noopener">ResearchBib</a>.</p> <p><strong><strong><a title="PubMed and PubMed Central (PMC)" href="[Title+Abbreviation]" target="_blank" rel="noopener">In PubMed and PubMed Central (PMC)</a> (NLM ID: 101724850, Selected citations only)</strong></strong></p> Evaluation of the strength of the upper extremity in children with hemiplegia after stroke: a case series study 2023-03-09T17:38:53+00:00 Dimitra Katsantoni Anna Chalkia Giorgos Tsigaras Thomas Besios Konstantinos Chandolias <p>The brain is a system with multidimensional organization and architecture and requires a continuous supply of blood in order to normally function. If blood flow is interrupted for more than a few seconds, the brain is deprived of blood and oxygen, causing death in nerve cells in the affected area. Stroke in children after birth appears even more rarely than in adults. For the study, 10 children with hemiplegic cerebral palsy (7 boys and 3 girls) participated (mean age 10, 9 years), from the “General Hospital Hippocratio” of Thessaloniki, according to the inclusion criteria. The strength of the upper extremity was measured using the Jamar dynamometer and for the assessment of the balance the pediatric balance scale (PBS) affected and contralateral hands, results were analyzed and compared with norms for age and sex and related to the affected balance. It was found that the strength of the non-affected upper extremities was also reduced according to the data of the normal children and the balance was also affected because of the stroke. Physiotherapy programs may include exercises that give emphasis on the non-affected upper extremities, more similar research must be done on a bigger population.</p> 2023-03-23T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Implementation of inclisiran in UK primary care for patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents: rationale and design of VICTORION-Spirit, a pragmatic phase IIIb, randomised controlled study 2022-12-19T08:46:52+00:00 Paul M. Wilson Samantha Dixon Tracey Vell Peter Bower Linda Rootkin Claire Williams Adam Strong David Lawrence Rebecca Elvey Owen Williams Norman Stein J. Martin Gibson <p><strong>Background:</strong> Translational gaps exist in implementing health innovations rapidly in clinical practice. Pragmatic effectiveness and implementation studies, therefore, play a pivotal role in understanding how high-value health innovations could be deployed and delivered in healthcare systems to reduce barriers to adoption and provide more rapid patient benefit. VICTORION-Spirit is an ongoing pragmatic, 9-month, phase IIIb, open-label, multicentre, randomised controlled study evaluating the implementation, patient experience, and delivery of the subcutaneous lipid-lowering therapy, inclisiran sodium 300 mg, in participants with elevated low-density lipoprotein cholesterol (LDL-C) who are on established lipid-lowering medication, or have been recommended lipid-lowering therapy but are unable to tolerate treatment.</p> <p><strong>Methods: </strong>VICTORION-Spirit utilises a type 1 hybrid effectiveness-implementation design, where the primary objective is to demonstrate superiority of inclisiran with or without (±) behavioural support versus standard of care (SOC; e.g., statin and/or other lipid-lowering therapies) + behavioural support in terms of percentage reduction in LDL-C from baseline to Day 270 in a primary care setting. Secondary objectives will evaluate implementation of inclisiran ± behavioural support versus SOC + behavioural support through assessment of: patient satisfaction and patient activation/empowerment after treatment at Day 90; adherence to cardiovascular disease self-management; and serious adverse event profile. Additionally, a process evaluation ascertaining the views of: patients, providers, and National Health Service (NHS) commissioners will explore barriers and enablers to integrating inclisiran within primary care.</p> <p><strong>Conclusions:</strong> The results of VICTORION-Spirit have potential to change our approach to lipid management and inform further implementation efforts in healthcare systems, such as the NHS.</p> <p><strong>Trial registration:</strong> NCT04807400.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Effect of massage made with aromatherapy oil after mastectomy on acute arm pain and anxiety: a randomized controlled study protocol 2023-01-07T19:44:28+00:00 Muzeyyen Ataseven Nuray Sahin Orak <p><strong>Background:</strong> This article summarizes the study protocol currently used to evaluate the efficacy of aromatherapy massage for the relief of post-mastectomy anxiety and acute arm pain.</p> <p><strong>Methods</strong>: It is a prospective interventional type three-group, randomized controlled, drug-free clinical trial. Eligible patients will be randomly assigned to one of three groups. The population of the study will consist of 90 patients who have undergone simple mastectomy (SM) and modified radical mastectomy (MRM) in the general surgery ward of a training and research hospital in Turkey. After the operation, the arm on the operated side will be massaged with sesame oil in the first group (n=30), sesame-lavender oil in the second group (n=30), and paraffin oil in the third group (n=30).</p> <p><strong>Conclusions:</strong> The primary outcome is the level of acute arm pain and the level of state anxiety. The secondary outcome is vital signs and analgesic use status.</p> <p><strong>Trial registration</strong>: International standard randomized controlled trial number NCT05658367.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Concordance between urine and self-collected vaginal samples for high-risk HPV detection in cervical cancer screening 2023-02-21T18:12:44+00:00 Sreeya Bose Partha Basu Sankar Sengupta Ranajit Mandal <p><strong>Background:</strong> A system comprising of screening for pre-cancerous lesions succeeded by therapeutic interventions can greatly reduce the incidence of cervical cancer. High risk HPV detection in urine has proven itself as a potential primary screening tool. However, only a few studies have showed it’s concordance with matched self-collected vaginal samples while screening for high risk HPV infection in the community. Objective of the study was to determine the concordance between first void urine sample and self-collected vaginal sample for high risk HPV detection using Cobas 4800. The sensitivity and positive predictive value of screening by urine HPV testing for CIN 2+ detection would also be done along with its acceptability and cost analysis in community screening.</p> <p><strong>Methods:</strong> This study will include women between 30-60 years with intact cervix and no precancerous lesions. Self-sampling will be provided by participants in the form of urine and vaginal swab collection by the Collipee device and vaginal swab stick respectively. This will be followed by high risk HPV testing using Cobas 4800 technology. The participants will also be asked to fill up a questionnaire about the acceptability of urine sampling for cancer screening.</p> <p><strong>Conclusions: </strong>Screening tools can perhaps be diversified in order to suit the needs of low and middle income countries. Research and development of cervical cancer screening tools could hence bring to light feasible alternatives that could further improve compliance of non-attenders.</p> <p><strong>Trial registration:</strong> The trial is registered with clinical trials registry (CTRI/2023/01/049322).</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials The effect of technology on the occurrence of musculoskeletal disorders in students of high school in Greece 2023-01-25T10:53:52+00:00 Eleftheria Synolaki Konstantinos Chandolias Alexandra Hristara-Papadopoulou Ilias Kallistratos Amalia Mathioudaki Marianna Antonaki <p><strong>Background</strong>: There has been a rise in the proliferation of technological devices across the globe. Many children use electronic devices from the age of 3 years old, especially mobile phones. The prolonged use of electronic devices has led to a distortion of body posture, leading to musculoskeletal disorders, including neck, thoracic, and back pain, and tendonitis of the upper extremities, primarily when using one hand.</p> <p><strong>Methods</strong>: To prove the positive correlation between technology and musculoskeletal disorders and to answer the above questions, an online questionnaire was distributed to 120 students of high school from all over Greece. The questionnaire comprises questions from two standardized questionnaires, the internet addiction test (IAT) and the Nordic musculoskeletal questionnaire (NQS). In addition, respondents completed a medical history and supplementary questions about their physical condition and their attitudes when using electronic devices.</p> <p><strong>Results</strong>: The results show that there is a positive correlation between long-term use of electronic devices and the occurrence of musculoskeletal problems in all parts of the body (neck, chest, lower back, hip, and lower extremities), as well as students who chose the wrong postures, had much more symptoms in contrast to the students who chose the positions with the greatest alignment. Finally, physical activity decreased significantly as the respondents' hours of using electronic devices increased.</p> <p><strong>Conclusions:</strong> Uncontrolled use of electronic devices can be a factor in the onset of symptoms, but adopting correct posture while using the devices and the good physical condition of the students would significantly reduce pain.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Validation of interpretation of ST-elevation myocardial infarction using the smartphone based 12 lead electrocardiograms in comparison to the cardiologist-a cross sectional study, validation study, single-center study 2023-02-06T10:51:03+00:00 Sahil Mahajan Salil Garg Richa Sharma Yogendra Singh Nitin Chandola Tanuj Bhatia Basundhara Bansal <p><strong>Background:</strong> In patients experiencing an ST-elevation myocardial infarction (STEMI), rapid diagnosis leads to optimal clinical outcomes. Recent technology has provided access to a reliable means of obtaining an ECG reading through a smartphone application (app) that works with an attachment providing all 12-leads of a standard ECG system. We developed a 12-lead smartphone-based electrocardiogram (ECG) called “Spandan”, and an application to accurately assess the presence of STEMI in patients presenting with chest pain. Objectives of study was to perform clinical observation studies on the patients screened for STEMIs and evaluate the variation in the diagnosis of STEMIs detected in both 12-lead gold standard and Spandan 12 lead ECG.</p> <p><strong>Methods:</strong> This single-center study was carried out at Shri Mahant Indresh hospital (SMIH), Dehradun, Uttarakhand, India from April-2022 to November-2022. All patients (n=278) visiting the ECG room with symptoms of chest pain, shortness of breath and past history of cardiovascular disease at the department of cardiology of the SMIH, Dehradun were included in the study.</p> <p><strong>Results:</strong> Mean age (SD) was 53.96±15.31 years. The male gender participants was 75.17%. 14.3% were STEMI patients as per the standard 12 lead interpretation, smartphone ECG interpreted 7.1% of the participants as STEMI and cardiologist interpreted nearly 15.4% of the participants of STEMI.</p> <p><strong>Conclusions:</strong> This study confirmed the potential of a smartphone ECG for evaluation of STEMI and the feasibility of studying this technology further to define the diagnostic accuracy, limitations, and appropriate use of this new technology.</p> 2023-02-18T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Comparative, randomized-controlled trial on efficacy and safety of Lactobacillus rhamnosus GG and Saccharomyces boulardii in treatment of acute diarrhea in Indian children (COMPARE-GG trial) 2023-04-14T09:51:33+00:00 Shekhar Biswas Benshik Bal <p><strong>Background:</strong> Probiotics are routinely prescribed to boost gut health and reduce severity of diarrhea. This study aimed to compare the efficacy and safety of <em>Lactobacillus rhamnosus </em>GG (LrGG) and <em>Saccharomyces boulardii </em>as an adjunct treatment for acute diarrhea in Indian children aged 6–36 months.</p> <p><strong>Methods:</strong> In this single-center, open label, comparative, randomized controlled study, children were randomized into three groups (n=35, each) and provided either low osmolarity oral rehydration solution (ORS) and zinc (20 mg/day) alone or ORS+Zinc supplemented with one of the two probiotic preparations, LrGG ATCC 53103 or <em>S. boulardii </em>CNCM 1-745. Children were monitored every 8 hours after admission and the duration of diarrhea and hospital stay, and stool frequency were evaluated.</p> <p><strong>Results:</strong> Of the total 105 children enrolled in the study, majority were aged between 13–24 months (40%). LrGG significantly reduced the mean duration of diarrhea by nearly 19 hours, when compared to the control group (p=0.003), while reduction by <em>S. boulardii </em>was not significant. The mean hospital stay duration for control group was about 6 days, which was significantly reduced (p=0.0001) by nearly 23 hours by LrGG, and non-significantly by <em>S. boulardii</em>. On day 2, LrGG significantly reduced stool frequency by 32.31%, as compared to 27.44% reduction in control group. <em>S. boulardii</em> reduced stool frequency by 31.76%, which was not statistically significant compared to that in control group.</p> <p><strong>Conclusions: </strong>LrGG showed statistically significant reduction in duration of diarrhea and hospital stay, when compared against the group receiving ORS+zinc either alone or with <em>S. boulardii</em>.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials A multi-center, randomized, controlled, phase-2/3 study to evaluate the safety and immunogenicity of inactivated Japanese encephalitis vaccine in healthy ≥1 to <3 years old Indian children 2023-01-02T08:48:01+00:00 Subhash Thuluva Kishore Turaga Subba Reddy G. V. Rammohan Reddy M. Vijay Yerroju Pothakamuri Venkata Suneetha Ramesh V. Matur <p><strong>Background:</strong> Japanese encephalitis (JE) is endemic in various parts of India. Due to the limited treatment options available, a new treatment option that is safe and effective is highly expected for the existing medical needs.</p> <p><strong>Methods:</strong> In the present randomized Phase-2/3 study, safety, immunogenicity, and reactogenicity of JE-vaccine manufactured by Biological E (BE-JE), given in 2-dose schedule, 28-days apart was assessed in 456 healthy ≥1 to &lt;3-year-old children compared to a licensed JE-vaccine with 3-dose schedule manufactured by Green-cross-corporation (GCC-JE).</p> <p><strong>Results:</strong> The BE-JE group demonstrated non‑inferiority compared to GCC-JE group at day-56 as the lower confidence limit of the group difference was not ≥‑10%. At day-56, the geometric mean titre values were significantly higher in BE-JE group compared with the GCC‑JE group (217.97 vs 125.85; p=0.0023). No apparent difference was seen in the safety-profile between both vaccine groups, with all events reported being either mild or moderate in intensity. Also, no significant difference (p=0.2198) was reported in the number of subjects experiencing at least one adverse-event (AE) between both groups.</p> <p><strong>Conclusions:</strong> The present study demonstrated BE‑JE’s Vero-cell‑based inactivated JE-vaccine, administered in 2-dose schedule to be immunogenic, well-tolerated, and non-inferior, compared to GCC‑JE-vaccine, administered in a 3‑dose schedule in the pediatric Indian-population.</p> <p>This study was prospectively registered with clinical trial registry of India bearing no CTRI/2011/091/000108 on 14/02/2011.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Health seeking behavior of in tuberculosis patients during COVID-19 pandemic and lockdown in a tertiary care center 2023-01-03T04:15:33+00:00 Arivudai Nambi Veerappan Periasamy Yazhlini . <p><strong>Background</strong>: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in India in 2020 having originated from China in late 2019. There is no study on the impact of covid management burden on tuberculosis (TB) management. Study on the effect of lockdown on TB management is also unknown. This is a pilot study.</p> <p><strong>Method:</strong> It is hypothesised that only people who are severely symptomatic will get tested for TB and severely sick patients will get admitted during the lockdown period. Data from outpatient TB clinic and inpatient ward were analysed.</p> <p><strong>Results:</strong> During the lockdown of 5 months saw severe fall in the attendance of the outpatient to 727 patients which was almost 44.44% of the pre lockdown patients, sputum positive among them were 160, positivity rate was 21.69. The total inpatients admission in the lockdown period of 6 months was 130 with average of 26 per month (36% of normal). The Wald chi-square for outpatient p=0.00 with CI=43.30-63.81. The Wald chi-square test for inpatient admission p=0.00 with CI=31.66-49.52. The results of inpatients admission showed that only sick and serious patients approached hospital in the lockdown period.</p> <p><strong>Conclusions:</strong> The results in the outpatient setting showed that mild to moderate symptomatic patients may not seek consultation only severe cases approached healthcare leading to spread.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Validation of the detection of ischemia using 12 lead smartphone based electrocardiography - a non-randomized, single blinded, cross-sectional, multicenter study 2023-03-09T15:44:06+00:00 Sahil Mahajan Salil Garg Richa Sharma Yogendra Singh Nitin Chandola Tanuj Bhatia Basundhara Bansal <p><strong>Background:</strong> Reliable and early detection of myocardial ischemia using computer-aided analysis of electrocardiograms (ECG) provides an important reference for early diagnosis of CVD. We developed a 12-lead smartphone-based electrocardiogram (ECG) acquisition and monitoring system (called “Spandan”), and an application to assess underlying ischemia from analysis of electrocardiographic (ECG) signals only. Objectives of this study were to validate the Spandan 12 lead ECG interpretation for accuracy in the detection of Ischemia in comparison to cardiologists’ diagnosis and to evaluate the accuracy of ischemia in comparison to the interpretation of standard 12 lead ECG.</p> <p><strong>Methods:</strong> In this multi-center study all patients (n=597) visiting the ECG room at the department of cardiology were enrolled in the study by taking their written consent and explaining the purpose of the study.</p> <p><strong>Results:</strong> Mean age was 52.85 years. The male gender (n=344, 57.62%) shows the maximum frequency than female gender. 12 lead Spandan smartphone ECG recorded fewer false positive cases (8 versus 230) and identified greater true negative cases (310 versus 115). Spandan smartphone ECG recorded better specificity (97.4% versus 33.3%) and positive predictive value (87.4% versus 51.4%) as compared to gold standard ECG. The accuracy of interpretation of Ischemia by cardiologists diagnosis through 12 lead Spandan smartphone ECG was better (100%) as compared gold standard (95.3%).</p> <p><strong>Conclusions: </strong>Our study highlights the potential of Spandan smartphone ECG in the detection of myocardial ischemia. This may improve patient satisfaction and reduce healthcare costs.</p> <p> </p> 2023-04-11T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations 2023-03-13T20:00:54+00:00 Sylvia Baedorf Kassis Weidong Lu Sarah A. White Anita Giobbie-Hurder Anna Tanasijevic Anna_Tanasijevic@DFCI.HARVARD.EDU Hyun-Jung Jung Xiping Zhang Im H. Shin Sung H. Park Young J. Jeong Chang Yao Jennifer Ligibel Barbara E. Bierer <p>The global SARS-COV-2 pandemic has significantly impacted the delivery of clinical care as well as the conduct of international clinical trials. A coordinated, multinational acupuncture study, consisting of three parallel randomized studies with a planned pooled analysis of individual patient data, was initiated in 2019 with the goal of assessing whether acupuncture relieved hot flash symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Eligibility included persistent hot flashes on endocrine therapy. Participants were randomly assigned to receive either immediate or delayed acupuncture in equal proportions; the primary endpoint was assessed at week 10, after completion of the immediate acupuncture treatments and before the delayed treatment sessions began. The trial was conducted in China, South Korea and United States of America (USA) and was in the midst of enrollment and study procedures when the COVID-19 pandemic began. Despite numerous challenges, the study was nonetheless completed successfully. We deployed a process evaluation method to describe each site’s experiences in conducting this multinational study during the pandemic. Using these observations, we offer measures for the planning and conduct of future studies, taking into account preparedness considerations in the event of exigent and demanding global circumstances.</p> 2023-04-26T00:00:00+00:00 Copyright (c) 2023 International Journal of Clinical Trials