International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct <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 http://www.ijclinicaltrials.com. 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="mailto:editor@ijclinicaltrials.com" target="_blank" rel="noopener">editor@ijclinicaltrials.com</a>, <a href="mailto:medipeditor@gmail.com" target="_blank" rel="noopener">medipeditor@gmail.com</a></p> <p><strong>Print ISSN:</strong> 2349-3240</p> <p><strong>Online ISSN:</strong> 2349-3259</p> <p><strong>Publisher:</strong> <a href="http://www.medipacademy.com" target="_blank" rel="noopener"><strong>Medip Academy</strong></a></p> <p><strong>DOI prefix: 10.18203</strong></p> <p><strong><a href="https://sci-index.org/journal/international-journal-of-clinical-trials" target="_blank" rel="noopener">IMPACT FACTOR</a>: 1.96</strong></p> <p>Medip Academy is a member of Publishers International Linking Association, Inc. (PILA), which operates <a href="http://www.crossref.org" 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="https://www.ijclinicaltrials.com/index.php/ijct/about/submissions#onlineSubmissions" target="_blank" rel="noopener">Online Submissions</a>:</p> <p>About the Journal &gt; <a title="Online Submissions" href="https://www.ijclinicaltrials.com/index.php/ijct/about/submissions#onlineSubmissions" 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="mailto:editor@ijclinicaltrials.com">editor@ijclinicaltrials.com</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="http://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Int+J+Clin+Trials%22[Title+Abbreviation]" target="_blank" rel="noopener"><strong>PubMed and PubMed Central (PMC)</strong> (NLM ID: 101724850, Selected citations only)</a>, </p> <p><a href="https://sci-index.org/journal/international-journal-of-clinical-trials" target="_blank" rel="noopener"><strong>Science Citation Index</strong></a> (Impact Factor: 1.96),</p> <p><a title="Scilit (MDPI)" href="https://www.scilit.net/wcg/container_group/14673" target="_blank" rel="noopener">Scilit (MDPI)</a>, </p> <p><a href="https://imsear.searo.who.int/handle/123456789/156145" target="_blank" rel="noopener">Index Medicus for South-East Asia Region</a> (WHO),</p> <p><a title="https://openalex.org/sources/s2764994790" href="https://openalex.org/sources/s2764994790" target="_blank" rel="noopener">OpenAlex,</a></p> <p><a title="https://www.semanticscholar.org" href="https://www.semanticscholar.org" target="_blank" rel="noopener">Semantic Scholar,</a></p> <p><a href="http://www.journaltocs.ac.uk/index.php?action=search&amp;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="https://journals.indexcopernicus.com/search/journal/issue?issueId=all&amp;journalId=31395" target="_blank" rel="noopener">Index Copernicus</a>,</p> <p><a href="http://www.crossref.org/titleList/" target="_blank" rel="noopener">CrossRef</a>,</p> <p><a href="http://www.indexscholar.com/?source=7105" target="_blank" rel="noopener">Index Scholar</a>,</p> <p><a href="http://www.journalindex.net/visit.php?j=9594" target="_blank" rel="noopener">Journal Index</a>,</p> <p><a href="https://scholar.google.co.in/" target="_blank" rel="noopener">Google Scholar</a>,</p> <p><a href="http://jgateplus.com/search/login/" target="_blank" rel="noopener">J-Gate</a>,</p> <p>Directory of Science,</p> <p><a href="http://journalseeker.researchbib.com/?action=viewJournalDetails&amp;issn=23493240&amp;uid=rdeac3" target="_blank" rel="noopener">ResearchBib</a>.</p> en-US medipeditor@gmail.com (Editor) editor@ijclinicaltrials.com (Editor) Tue, 28 Jul 2026 19:09:23 +0530 OJS 3.3.0.13 http://blogs.law.harvard.edu/tech/rss 60 Perceptions and challenges of caregiving for the elderly in rural communities https://www.ijclinicaltrials.com/index.php/ijct/article/view/932 <p>The qualitative research examines the experiences of caregivers (CGs) in rural settings, with the emotional, psychological, and practical difficulties of looking after elderly relatives. Seven individuals, including spouses, children, and in-laws, were interviewed to gather information on caregiving experiences across five main thematic areas: the functions and emotional dimensions of caregiving, difficulties in rural areas, socio-economic obstacles, cultural and societal values, effects on CGs, and elderly health. CGs frequently encounter emotions, such as stress, guilt, fatigue, and burnout, due to the scarcity of resources and social support in rural areas. The COVID-19 pandemic has exacerbated the difficulties caused by isolation and reduced accessibility. Economic challenges associated with CGs. Cultural norms in rural areas compel people to offer care without assistance. Well-being of CGs is significantly linked to the health outcomes of older adults. This highlights the necessity for improved support systems, increased healthcare availability, social services, and respite care to ease the strain on CGs with further studies.</p> Annie Vedha Tamil Selvi T., Navaneetham D. Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/932 Tue, 28 Jul 2026 00:00:00 +0530 Do brain activity patterns differ between chronic musculoskeletal pain patients and healthy controls as measured by functional neuroimaging techniques? A systematic review protocol https://www.ijclinicaltrials.com/index.php/ijct/article/view/962 <p><strong>Background:</strong> Chronic musculoskeletal pain has been associated with changes at various levels regarding pain processing. One of the fields that has highlighted such differences between healthy individuals and people suffering from chronic musculoskeletal pain is neuroimaging of the brain. The mixed results arising from the different pathologies in addition to the use of different imaging modalities do not offer a conclusive overview, implicating the interpretation of the findings and their relevance as a causal or a consequent factor to chronification of pain. The aim of this systematic review is to provide a comprehensive summary of the available evidence assessing chronic painful conditions against healthy populations per functional neuroimaging modality. <strong> </strong></p> <p><strong>Methods:</strong> The protocol for this systematic review was informed and reported in line with the Preferred Reporting Items for Systematic Reviews. The databases that will be searched from inception to a prespecified date include PubMed, EMBASE (Ovid Interface), Scopus, Cochrane Library and Web of Science (Clarivate Analytics). Risk of bias will be assessed with the Newcastle-Ottawa tool and the quality of the cumulative evidence with the Grading of Recommendations, Assessment, Development and Evaluation guidelines.</p> <p><strong>Conclusions:</strong> The results of this review will provide an up-to-date report on what the main findings of brain neuroimaging per pathological population and imaging modality are, assessing at the same time the quality of the evidence and indicating future directions in the field of neuroimaging assessment of the musculoskeletal patient.</p> <p><strong>Trial Registration:</strong> Current control trial is CRD42024494813.</p> Achilleas Paliouras, Paraskevi Bilika, Konstantina Savvoulidou, Stephane Perrey, Aristeidis Zibis, Eleni Kapreli Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/962 Tue, 28 Jul 2026 00:00:00 +0530 The effect of relaxation breathing exercise on chemotherapy induced nausea and vomiting in patients with hematological malignancies https://www.ijclinicaltrials.com/index.php/ijct/article/view/977 <p><strong>Background:</strong> Chemotherapy is widely used in the treatment of hematological malignancies despite it has important and difficult side effects in patients. Chemotherapy induced nausea and vomiting are among the most common side effects in patients and antiemetic drugs may not be always curative. This research aimed to determine the effectiveness of relaxation breathing exercise on managing chemotherapy induced nausea and vomiting in patients with hematological malignancies undergoing chemotherapy.</p> <p><strong>Methods:</strong> A randomized controlled trial design was conducted with a total of selected sixty-eight patients with hematological malignancies (34 intervention and 34 control participants) undergoing chemotherapy hospitalized in the hematology clinic of a training and research hospital. The intervention group implemented relaxation breathing exercise three times a day with a standard treatment protocol and the control group only received routine drug treatment for chemotherapy induced nausea and vomiting. Nausea and vomiting were assessed by filling Rhodes ındex of nausea vomiting and retching (RINVR) for the first six days after the start of the chemotherapy. Data collection process ended. Data analysis process is in progress.</p> <p><strong>Conclusions: </strong>In this study the effectiveness of relaxation breathing exercise on chemotherapy related nausea and vomiting will be examined in patients with hematological malignancies.</p> <p><strong>Trial Registration:</strong> The study was registered at clinicaltrials. gov.tr (Registration No: NCT07456982).</p> Pınar Ekşi, Sıdıka Oğuz Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/977 Tue, 28 Jul 2026 00:00:00 +0530 An integrative mind-body approach for screen-related neuro-ocular fatigue and cognitive exhaustion: a case report https://www.ijclinicaltrials.com/index.php/ijct/article/view/966 <p>Digital eye strain (DES), also known as computer vision syndrome (CVS), is an increasingly prevalent health concern associated with prolonged digital screen exposure, characterized by ocular discomfort, visual fatigue, reduced cognitive efficiency, and sleep disturbances. Current management approaches are largely symptomatic and often fail to address the multifactorial neuro-ocular and cognitive aspects of the condition, highlighting the need for holistic, non-pharmacological interventions. We report the case of a 37-year-old male information technology professional who presented with a four-month history of eye strain, frontal headaches, blurred vision after prolonged screen use, irritability, reduced concentration, and difficulty initiating sleep. Baseline assessment using the CVS questionnaire (CVS-Q), ocular surface disease index (OSDI), Pittsburgh sleep quality index (PSQI), and fatigue severity scale (FSS) demonstrated clinically significant DES, moderate ocular discomfort, poor sleep quality, and cognitive fatigue. The patient underwent a two-week integrated intervention comprising yoga therapy, naturopathy-based lifestyle modifications, and acupuncture. Following the intervention, marked improvements were observed, with CVS-Q scores decreasing from 18 to 6, OSDI from 32% to 12%, PSQI from 11 to 5, and FSS from 5.8 to 3.1, reflecting reduced ocular symptoms, improved sleep quality, and decreased cognitive fatigue. The patient also reported enhanced daily comfort, improved work productivity, and better sleep without pharmacological treatment. This case suggests that an integrated yoga, naturopathy, and acupuncture approach may be a safe and effective strategy for managing screen-related neuro-ocular fatigue and cognitive exhaustion, warranting further evaluation through well-designed controlled studies.</p> Sabeetha Soundarapandiyan, Sushanthikaa Balasubramaniam, Yogapriya Chidambaram, Seithoon Nisha Mohamed Ali, Booshna Sandiracala, Dhilip V. Ravindran Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/966 Tue, 28 Jul 2026 00:00:00 +0530 Anaplastic pleomorphic xanthoastrocytoma in a 12-year-old with early leptomeningeal dissemination: a rare pediatric case report from Central India https://www.ijclinicaltrials.com/index.php/ijct/article/view/999 <p>Pleomorphic xanthoastrocytoma (PXA) is a rare glioma subtype, making up less than 1% of astrocytoma, mainly affecting young adults. It typically appears in solid, cystic, or mixed forms in the supratentorial region, especially the temporal lobe, with a peak onset around age 20. Reported cases describe cerebrospinal fluid dissemination, often occurring months after diagnosis. We report a case of 12-year-old boy presenting with headache and vomiting for over a month, with no significant medical or family history. Magnetic resonance imaging brain showed lesion in the right fronto-parietal region. He underwent surgery to excise the lesion, which was diagnosed as a PXA, classified as World Health Organization (WHO) grade 3. Immunohistochemical analysis indicated positivity for ATRX, H3K27me3, and p53 protein suggesting high-grade glial tumor. After surgery, he had recurrence of headache within a month. Follow-up magnetic resonance imaging revealed residual tumor, leading to second surgery for tumor re-exploration. He received adjuvant radiation therapy and chemotherapy with Temozolomide. Despite treatment, he re-developed symptoms, and further imaging showed metastasis in the left medial temporal lobe and lumbar spine. Unfortunately, he did not respond to chemotherapy and passed away within a month. This case highlights the complex behavior of PXA, which complicates disease management. It denotes surgical excision alone is inadequate and should be complemented by spine staging scans and radiation therapy. Poor prognosis indicators include necrosis, high mitotic activity and incomplete resection underscoring the need for comprehensive treatment approach.</p> Shyamji Rawat, Navya S. Boppadapu, Anjanette Nabiyal, Abhishek Badgoliya, Karthick Raju V. A., Dhirendra K. Panwar Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/999 Tue, 28 Jul 2026 00:00:00 +0530 Cardiovascular events related to the treated coronary artery after surgical or percutaneous revascularization in patients with stable multivessel coronary artery disease: long-term comparison with medical treatment https://www.ijclinicaltrials.com/index.php/ijct/article/view/971 <p><strong>Background:</strong> Myocardial revascularization via coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) is central for complex coronary artery disease (CAD). However, post-procedural adverse cardiovascular events remain challenging. Traditional efficacy assessments use composite endpoints, such as major adverse cardiovascular events (MACE), which include events unrelated to the treated artery, potentially compromising the evaluation of the intervention's true clinical impact. Objectives were to compare adverse cardiovascular events-nonfatal myocardial infarction and cardiac death-directly attributable to the artery treated by CABG or PCI, versus patients with similar CAD managed exclusively with medical therapy.</p> <p><strong>Methods:</strong> This comparative study includes patients with stable multivessel CAD undergoing CABG, PCI, or medical therapy alone. Only clinical events anatomically linked to the treated artery (or the target vessel in the medical therapy cohort) will be analyzed. This methodology aims to deliver a precise evaluation of the technical and clinical efficacy of each revascularization strategy.</p> <p><strong>Results:</strong> Data collection and statistical analysis are ongoing. The upcoming results will detail and compare the precise incidences of vessel-related myocardial infarction and cardiac death across the three therapeutic groups.</p> <p><strong>Conclusions:</strong> By prioritizing vessel-specific outcomes over traditional composite endpoints, this study addresses existing methodological limitations. It offers an accurate assessment of PCI and CABG efficacy in real-world clinical practice, aiming to guide individualized, evidence-based therapeutic decisions for stable CAD management.</p> Thiago Hueb, Edimar Alcides Bocchi, Paulo Cury Rezende, Eduardo Gomes Lima, Thiago Luis Scudeler, Paulo Rogério Soares, Fabio Antonio Venancio, Maria Stanislavovna Ta, Giovana Outuki, Izabela Jacob Martins, Ezio De Martino Neto, Carlos Vicente Serrano, Jose Antônio Franchini Ramires, Roberto Kalil Filho Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/971 Tue, 28 Jul 2026 00:00:00 +0530 Increasing black Americans’ participation in clinical trials: a qualitative analysis https://www.ijclinicaltrials.com/index.php/ijct/article/view/954 <p><strong>Background:</strong> Black Americans are underrepresented in clinical trials, a disparity that limits the applicability of medical research and perpetuates health inequities. This underrepresentation is particularly urgent given its implications for health outcomes, as it hinders the development of treatments tailored to diseases disproportionately affecting Black populations, such as hypertension, diabetes, and certain cancers. Without equitable representation in clinical trials, advancements in these areas may not fully address the unique needs of Black communities, further exacerbating existing health disparities.</p> <p><strong>Methods: </strong>This qualitative study analyzed data from four focus groups conducted in the summer of 2024 to explore perceptions of clinical trials among Black Americans. Participants, primarily over the age of 40, were recruited from diverse community settings. Deductive content analysis identified themes around knowledge gaps, attitudes, barriers, motivators, and communication strategies for healthcare providers.</p> <p><strong>Results:</strong> Results revealed a general understanding of the purpose of clinical trials. Barriers included mistrust rooted in historical injustices, logistical challenges, and perceived risks, while motivators focused on community benefits, compensation, and ease of participation. Participants emphasized the importance of clear, culturally sensitive communication and suggested leveraging a wide variety of marketing channels and community partnerships.</p> <p><strong>Conclusions:</strong> These findings will guide the development of a social marketing campaign, and a provider training curriculum aimed at increasing clinical trial participation among marginalized communities.</p> Billie Castle, Petera Diaban, LeKeisha Williams, Patricia Davis, William Kirchain, Soon Ja Elzey Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/954 Tue, 28 Jul 2026 00:00:00 +0530 Demographics and trends of hepatocellular carcinoma: a prospective study in a tertiary care centre, Central India https://www.ijclinicaltrials.com/index.php/ijct/article/view/987 <p><strong>Background: </strong>Hepatocellular carcinoma (HCC), the most frequent primary liver malignancy, ranks as the sixth leading cause of incidence and the third leading cause of cancer-related mortality worldwide, with a heavy healthcare burden in Asian countries. Epidemiological data from India remain limited and are predominantly based on studies conducted in urban settings; therefore, we aimed to assess the demographic characteristics, analyze the etiological spectrum, and identify changing trends in the etiology of HCC in Central India.</p> <p><strong>Methods: </strong>A prospective analysis of patients presented with HCC from January 2022 to December 2024, conducted in the State Cancer Institute NSCB Medical College, Jabalpur, Madhya Pradesh, a tertiary cancer care centre in Central India. Patient data and details were collected and analysed prospectively.</p> <p><strong>Results: </strong>We conducted a study from January 2022 to December 2024, enrolling a total of 48 patients. The majority were male, with a mean age of 55-58 years. A substantial proportion had a history of alcohol consumption (42%) and tobacco use (46%). Overall, hepatitis B (HBV) (47.92%) emerged as the predominant etiological agent among cases with known risk factors. Most patients presented to our institute with advanced-stage disease (Stage III or IV). The advanced stage at presentation resulted in many patients being unsuitable for curative treatment.</p> <p><strong>Conclusions:</strong> The incidence of HCC is low among all cancers, but it carries a high mortality rate. Alcohol consumption and viral hepatitis were the most common causes. The disease is more common in individuals above 40 years of age, particularly in males.</p> Shyamji Rawat, Abhishek Badgoliya, Pankaj Asati, Anjanette Nabiyal, Ekta Kotwal, Karthick Raju V. A., B. Navya Sahithi, Lalit Mohan Patel Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/987 Fri, 08 May 2026 00:00:00 +0530 Metaberine (bio-optimised berberine 200 mg/day) improves metabolic health markers in healthy adults: a randomized, double-blind and placebo-controlled crossover trial https://www.ijclinicaltrials.com/index.php/ijct/article/view/1028 <p><strong>Background:</strong> Berberine shows promise for metabolic health but suffers from poor bioavailability requiring high daily doses (500–1500 mg/day) that frequently cause gastrointestinal side effects. We evaluated whether a biooptimised berberine formulation (Metaberine™) developed using BioSOLVE technology could provide meaningful metabolic benefits at substantially lower doses.</p> <p><strong>Methods:</strong> In this randomized, double-blind, placebo-controlled crossover trial, 36 healthy adults (mean age 39.9 years, BMI 25.8 kg/m²) with fasting glucose 100–125 mg/dl received Metaberine™ 200 mg or placebo once daily for 14 days per period (7-day washout). Primary outcomes were fasting and postprandial blood glucose during a 75 g oral glucose tolerance test (OGTT) at 0, 30, 60, 90 and 120 minutes. Secondary outcomes included plasma GLP-1, glucose concentration parameters (AUClast, Cmax), lipid profile and safety.</p> <p><strong>Results:</strong> Metaberine™ significantly improved all glycemic parameters: fasting glucose decreased by 9.08 mg/dl versus 1.36 mg/dl with placebo (p&lt;0.0001), with significant reductions at all postprandial timepoints. Baseline-corrected glucose AUClast and Cmax decreased by 13.5% and 12.7%, respectively (both p&lt;0.0001). Plasma GLP-1 increased by 29% (fasting) and 22% (postprandial) with Metaberine™ versus minimal change with placebo (both p&lt;0.0001). Lipid profiles improved with decreases in total cholesterol and LDL-C and an increase in HDL-C. Safety was excellent with 100% participant retention and no supplement-related adverse events.</p> <p><strong>Conclusions:</strong> These findings demonstrate that biooptimised berberine at 200 mg/day a 5–7-fold lower dose than conventional formulations significantly improve glycemic control, enhances incretin response and favorably modulates lipid metabolism in healthy adults at metabolic risk, supporting its potential as a functional nutritional ingredient for metabolic wellness.</p> Shankaranarayanan Jeyakodi, Arunkanth Krishnakumar, Devendra N. Naik, M. Mohamed Hussain, Jestin V. Thomas Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/1028 Tue, 28 Jul 2026 00:00:00 +0530 Evaluation of the effectiveness of injectable platelet-rich fibrin on the rate of orthodontic tooth movement: a clinical study https://www.ijclinicaltrials.com/index.php/ijct/article/view/1014 <p><strong>Background: </strong>Prolonged orthodontic treatment duration remains a major clinical concern because of its association with root resorption, enamel decalcification, periodontal complications, and reduced patient compliance. Injectable platelet-rich fibrin (I-PRF), a second-generation autologous platelet concentrate rich in growth factors and inflammatory mediators, has recently gained attention as a minimally invasive adjunct for accelerating orthodontic tooth movement (OTM). Aim was to evaluate the effectiveness of I-PRF on the rate of OTM during maxillary canine retraction.</p> <p><strong>Methods: </strong>This prospective split-mouth clinico-experimental study included nine patients requiring bilateral maxillary first premolar extractions for orthodontic treatment. The right maxillary quadrant received intraligamentary I-PRF injections, while the contralateral side served as the control. Canine retraction was performed using nickel-titanium closed-coil springs delivering 150 g force on 0.019″×0.025″ stainless steel archwires. I-PRF was prepared using low-speed centrifugation at 700 rpm for 3 minutes and administered at baseline and eighth week. OTM was evaluated monthly for three months using three-dimensional digital model superimposition. Statistical analysis included paired t-test, repeated measures ANOVA, and Bonferroni post-hoc analysis.</p> <p><strong>Results: </strong>The I-PRF group demonstrated greater OTM compared to the control group at all evaluated intervals. Statistically significant differences were observed during the initial phase of retraction and in cumulative tooth movement from baseline to the third month. Repeated measures ANOVA revealed significant variation in tooth movement across different intervals in both groups.</p> <p><strong>Conclusions: </strong>I-PRF demonstrated a positive effect on accelerating OTM and may serve as an effective, minimally invasive biologic adjunct for enhancing orthodontic treatment efficiency.</p> <p><strong> </strong></p> Benezer Rapsang, Vaibhav Misra, Ankit Garg, Sonal Attri, Deepanshi Yadav Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/1014 Tue, 28 Jul 2026 00:00:00 +0530 One eye at a time: feasibility of unilateral 0.5% pilocarpine therapy in presbyopia management https://www.ijclinicaltrials.com/index.php/ijct/article/view/984 <p><strong>Background:</strong> The objective of the study was to evaluate the feasibility, efficacy, and patient tolerance of unilateral instillation of 0.5% pilocarpine for near vision improvement in presbyopic individuals.</p> <p><strong>Methods:</strong> This prospective interventional study included 130 eyes of 65 presbyopic individuals. A single drop of 0.5% pilocarpine was instilled in one eye of each participant once daily. Distance corrected near visual acuity was assessed uniocularly and binocularly on the 7th and 15th day following initiation of treatment. Subjective improvement in near vision was recorded using patient feedback on comfort and functional near tasks. Binocular vision, stereopsis, and patient- reported outcomes regarding reading comfort, glare, headache, and overall satisfaction were documented at each visit. After completion of 15 days, the same protocol was repeated in the fellow eye of the patient, following a unilateral sequential treatment approach. Statistical analysis was performed using paired t-test and Wilcoxon signed-rank test, as appropriate.</p> <p><strong>Results:</strong> The results demonstrated a clear and progressive improvement in near visual acuity over the two-week period with unilateral administration of 0.5% pilocarpine. Subjective assessment revealed improved reading ease and reduced dependance on near correction in the majority of participants. The treatment was well tolerated. Reported ocular side effects were mild and transient, including brow ache and mild dimming of vision, with no serious adverse effects recorded.</p> <p><strong>Conclusions: </strong>Unilateral administration of 0.5% pilocarpine is an effective and safe strategy for presbyopia management, providing meaningful binocular visual function. Sequential unilateral treatment may offer a practical, patient-friendly non-surgical option for presbyopia management.</p> Sourabh Kumar, Sonali Vinay Kumar, Kalpamoi Kakati, Ranjit Goenka, Vinay Kumar, Alok Sati Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/984 Tue, 28 Jul 2026 00:00:00 +0530 Interplay between psychological resilience and emotional burden in knee osteoarthritis: a cross-sectional analysis of pain perception and functional disability https://www.ijclinicaltrials.com/index.php/ijct/article/view/997 <p><strong>Background:</strong> Knee osteoarthritis (OA) is a common cause of chronic pain and functional disability, frequently associated with psychological distress. Emotional burden, including depression and anxiety, may exacerbate symptoms, while psychological resilience may act as a protective factor.</p> <p><strong>Methods:</strong> A cross-sectional study was conducted among 108 patients aged 45–70 years with clinically diagnosed knee OA, according to EULAR diagnostic criteria. The mean age of patients was 55.92±0.8 years, and the mean BMI was 27.24±0.4 kg/m<sup>2</sup>. Emotional burden was assessed using the PHQ-9 and GAD-7, and resilience using the brief resilience scale. Functional disability and pain were evaluated using the WOMAC index. Pearson correlation analysis was performed.</p> <p><strong>Results:</strong> Mean scores for depression, anxiety, and resilience were 8.97±5.93, 9.35±5.97, and 20.33±7.11, respectively. Depression showed no significant correlation with functional disability (r=0.04, p=0.69). Anxiety (r=-0.18, p=0.07) and resilience (r=-0.17, p=0.09) demonstrated weak inverse correlations with WOMAC scores.</p> <p><strong>Conclusions: </strong>Although not statistically significant, consistent inverse trends suggest a potential role of psychological factors in functional outcomes, supporting a multidimensional approach to knee OA management, including psychological assessment and intervention.</p> Aavrati Rastogi, Roop B. Kalia, Anindya Das, Mukesh Bairwa Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/997 Tue, 28 Jul 2026 00:00:00 +0530 Clinicopathological relevance of Ki-67 expression and its association with immunoprofile in breast cancer https://www.ijclinicaltrials.com/index.php/ijct/article/view/1004 <p><strong>Background: </strong>Ki-67 is a widely used proliferation marker in breast carcinoma; however, its prognostic relevance remains inconsistent due to variability in assessment and lack of standardized cut-offs. Its correlation with established clinicopathological parameters and hormone receptor status continues to be an area of active investigation. Objectives were to evaluate Ki-67 expression and determine its association with clinicopathological features and immunohistochemical markers (ER, PR, HER2/neu) in invasive breast carcinoma.</p> <p><strong>Methods: </strong>This hospital-based cross-sectional study included 88 cases of primary invasive breast carcinoma. Ki-67 expression was assessed by immunohistochemistry and categorized as low (&lt;20%) or high (≥20%). Associations with tumor size, grade, lymph node status, lymphovascular invasion, perineural invasion, and hormone receptor status were analyzed using Chi-square/Fisher’s exact test. A p&lt;0.05 was considered statistically significant.</p> <p><strong>Results: </strong>High Ki-67 expression (≥20%) was observed in 44.3% of cases. Significant associations were noted between high Ki-67 expression and larger tumor size (p=0.018), higher histological grade (p=0.013), lymphovascular invasion (p=0.001), perineural invasion (p=0.002), and HER2/neu positivity (p=0.001). No significant association was found with age, lymph node metastasis, ER status, PR status, combined ER/PR status, or triple marker status.</p> <p><strong>Conclusions: </strong>Ki-67 expression demonstrates significant association with adverse pathological features and HER2/neu positivity, supporting its role as an adjunct prognostic marker in invasive breast carcinoma. Incorporation of Ki-67 into routine evaluation may enhance risk stratification, particularly in resource-limited settings; however, standardization of assessment methods remains essential for its optimal clinical utility.</p> <p><strong> </strong></p> Ankita Sharma, Neelam Sharma, Lalita Negi, Reetika Sharma, Anupam Parashar, Puneet Mahajan Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/1004 Tue, 28 Jul 2026 00:00:00 +0530 Motivators and barriers to clinical trial participation: a comparative review across socio-cultural and healthcare contexts https://www.ijclinicaltrials.com/index.php/ijct/article/view/1006 <p>Clinical trials remain essential for the advancement of evidence-based medicine and the development of new therapies. However, participant recruitment and retention continue to pose significant challenges globally, with under-enrolment affecting the success and generalisability of many clinical studies. Understanding the factors that motivate or hinder participation is therefore critical for improving recruitment strategies and ensuring equitable representation in clinical research. This study employed a systematic literature review and thematic synthesis of peer-reviewed journal articles, institutional reports, and patient perception surveys published between 2016 and 2026. Databases searched included PubMed Central, ScienceDirect, Semantic Scholar, and selected industry reports. The review identified personal benefit, altruism, and contribution to medical advancement as the most recurrent motivations for participation in clinical trials. Personal benefit, particularly access to advanced healthcare, close medical monitoring, and financial incentives, emerged as the strongest motivator across most studies. Major barriers included fear and safety concerns, lack of awareness, logistical constraints, mistrust in healthcare systems, financial limitations, and infrastructural inadequacies. Clinical trial participation is shaped by a complex interaction of individual, cultural, institutional, and systemic factors. While motivations are relatively consistent globally, barriers are more context-specific, particularly in developing countries. Improving public education, strengthening trust in healthcare systems, decentralising trial access, and enhancing infrastructural and regulatory capacity may improve participation rates and diversity in clinical research.</p> Jelilat Ahmed-Momoh Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/1006 Mon, 08 Jun 2026 00:00:00 +0530 Sample size in clinical research: why it matters and how it is determined https://www.ijclinicaltrials.com/index.php/ijct/article/view/988 <p>Sample size is a critical component of clinical research that directly influences the validity, reliability, and interpretability of study findings. Determining an appropriate sample size is not merely a statistical exercise but a multidisciplinary decision involving clinical relevance, study design, variability, and ethical considerations. An inadequately powered study may fail to detect meaningful treatment effects, whereas an excessively large study may expose unnecessary numbers of participants to interventions and increase study costs. This article provides a practical overview of why sample size matters in clinical research and explains the major factors that influence its determination. Examples from different study settings, including superiority, non-inferiority, and bioequivalence studies, are used to bridge statistical concepts with practical application. Common misconceptions surrounding sample size are also discussed to improve understanding among clinical research professionals.</p> Nitin Chandurkar, Kumar Naidu Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/988 Tue, 28 Jul 2026 00:00:00 +0530 Efficacy and impact of vision therapies on the rate of myopia control among youth: a systematic review study https://www.ijclinicaltrials.com/index.php/ijct/article/view/996 <p>The prevalence of myopia has significantly increased among children and young adults, making it a growing global public health concern. Orthokeratology, vision therapy, and binocular vision training are some of the vision therapies that have been suggested as possible interventions for myopia control. To review the current evidence on the role of vision therapies in controlling myopia progression. A comprehensive literature search was conducted to identify studies evaluating the effectiveness of vision therapies in myopia control. Studies were included if they reported outcomes on myopia progression, refractive error, or axial length. Refractive error can be decreased and the progression of myopia can be controlled with the help of vision therapies, particularly orthokeratology. These treatments may be viewed as supplementary to conventional myopia correction techniques. To completely comprehend the mechanisms and ideal procedures for vision therapy in the control of myopia, more research is required.</p> <p><strong> </strong></p> Jamshed Ali, Mohammad Nooruz Zaman, Daud Hasan Siddiqui, Wasif Mahmood Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/996 Mon, 15 Jun 2026 00:00:00 +0530 Evaluation of electrocardiographic and echocardiographic findings in patients with cardiomyopathy: a narrative review https://www.ijclinicaltrials.com/index.php/ijct/article/view/1011 <p>Cardiomyopathies represent a heterogeneous group of myocardial diseases characterized by structural and functional alterations of the heart muscle. These conditions are a significant cause of morbidity and mortality worldwide, frequently leading to heart failure, arrhythmias, and sudden cardiac death (SCD). Electrocardiography (ECG) and echocardiography are the cornerstone diagnostic tools in the evaluation of these conditions, providing critical information about cardiac structure, function, and electrical activity. The purpose of this narrative review is to examine the most clinically significant cardiomyopathies-dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), and restrictive cardiomyopathy (RCM)-with a focus on their epidemiology, pathophysiology, and the characteristic ECG and echocardiographic findings used in diagnosis and management. Relevant literature was identified through PubMed and major cardiology guidelines up to March 2021. Search terms included: “cardiomyopathy,” “dilated cardiomyopathy,” “hypertrophic cardiomyopathy,” “restrictive cardiomyopathy,” “ECG findings cardiomyopathy,” and “echocardiography cardiomyopathy.” HCM is the most prevalent primary cardiomyopathy with an estimated prevalence of 1 in 500 persons. Dilated cardiomyopathy (DCM) has a prevalence of approximately 1 in 2,500 and is the leading indication for cardiac transplantation. Restrictive cardiomyopathy (RCM) is the rarest of the three, accounting for approximately 2-5% of cardiomyopathy cases. Each type demonstrates distinct and clinically meaningful ECG and echocardiographic patterns. Cardiomyopathies are associated with significant cardiovascular risk, and HCM in particular remains the leading cause of SCD in young athletes in the United States. Early identification using ECG and echocardiography is essential for risk stratification and management. Distinguishing physiological cardiac remodeling from pathological disease requires comprehensive diagnostic evaluation.</p> Syed Nazar Raza, Naziya Yasmin, Manav Jyala, Syed Abeera Andrabi Copyright (c) 2026 International Journal of Clinical Trials https://www.ijclinicaltrials.com/index.php/ijct/article/view/1011 Tue, 28 Jul 2026 00:00:00 +0530