International Journal of Clinical Trials <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> Medip Academy en-US International Journal of Clinical Trials 2349-3240 Identification of patients at risk of cardiovascular disease in Greater Manchester in the VICTORION-Spirit study <p><strong>Background:</strong> Inclisiran is a cholesterol-lowering small interfering RNA treatment licensed in the UK for lowering low-density lipoprotein cholesterol (LDL-C). VICTORION-Spirit (NCT04807400) is an implementation science study designed to provide evidence for inclisiran implementation within the National Health Service. The aim was to describe the process of patient identification employed in VICTORION-Spirit.</p> <p><strong>Methods:</strong> A Phase IIIb, multicentre, randomised controlled study, VICTORION-Spirit is evaluating inclisiran implementation in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C. Feasibility Assessment and Recruitment System for Improving Trial Efficiency (FARSITE) software utilising natural language search functions identified patients who may benefit from inclisiran. FARSITE searches were performed within Salford, Manchester, Trafford and Bury Clinical Commissioning Groups to identify individuals with elevated LDL-C or total cholesterol and pre-existing cardiovascular disease (CVD) or at risk of ASCVD.</p> <p><strong>Results:</strong> FARSITE used ‘total cholesterol &gt;4 mmol/l’ terminology rather than ‘LDL-C’; the former yielded &gt;3 times the number of eligible patients. The search for individuals with pre-existing CVD identified 24,196 people in a population of 560,969 (4.3%); including ‘total cholesterol &gt;4 mmol/l’ identified 10,431 individuals with pre-existing CVD and elevated total cholesterol. Searches for individuals at risk of ASCVD identified 65,457 people, narrowing to 26,580 at risk of ASCVD plus elevated total cholesterol. The most discriminatory SNOMED concept codes and their prevalence within the dataset can inform national approaches to develop similar searches.</p> <p><strong>Conclusions: </strong>FARSITE searches employed in VICTORION-Spirit identified a population at risk of ASCVD in Greater Manchester, England, who may benefit from a cholesterol-lowering medication such as inclisiran.</p> J. Martin Gibson John McCrae Claire Williams Paul M. Wilson Peter Bower Samantha Dixon Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 1 9 10.18203/2349-3259.ijct20240038 Community perceptions and willingness to participate in COVID-19 vaccine trials: a qualitative study in Northern Ghana <p><strong>Background</strong>: Several COVID-19 vaccines were developed and are being tested to find effective vaccine to control the COVID-19 pandemic. The Navrongo health research centre was engaged to conduct trials on the safety and efficacy of some of the COVID-19 vaccines to inform policy in Ghana. This study explored perceptions and willingness to participate in the COVID-19 vaccine trials that were conducted in the Kassena-Nankana districts of Northen Ghana.</p> <p><strong>Methods</strong>: This study used qualitative research approach where 10 focus group discussions and 30 in-depth interviews were conducted with participants. The data were coded into themes using QSR NVivo 12 software before thematic analysis.</p> <p><strong>Results</strong>: The majority of participants perceived that the COVID-19 vaccine trial was a good initiative, which had helped people to get access to the vaccines to boost their immunity against the virus. However, some participants felt that it was not appropriate for NHRC to conduct the trials because of the perceived risks associated with the vaccines. Most participants said they were ready to participate in the trials if they were invited with many of them mentioning good health and compensation as the main factors that could influence their decision. Nonetheless, a good number of them maintained that they were not ready to participate because of perceived risks resulting from receiving the COVID-19 vaccines.</p> <p><strong>Conclusion</strong>: Our recommendation is that effective community engagement strategies by researchers such as collaborating with key community leaders, to actively get involved during community education prior to conducting clinical trials, could improve understanding and participation.</p> Samuel Tamti Chatio Nana Akosua Ansah Engelbert A. Nonterah Oscar Bangre Denis Awuni Irene Kuwolamo Victor Asoala Patrick Ansah Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 10 16 10.18203/2349-3259.ijct20240039 Comparative study of two thoracic segmental spinal anaesthesia techniques for laparoscopic cholecystectomy: low-dose hypobaric ropivacaine and isobaric ropivacaine at T10-11 intervertebral space vs. standard technique using isobaric levo bupivacaine at T8-T10 intervertebral space <p><strong>Background: </strong>Many prior studies have utilized thoracic or lumbar spinal anesthesia with isobaric/hyperbaric bupivacaine or Ropivacaine and opioids for laparoscopic cholecystectomy and have reported variable results. our study is centered around addressing the occurrence of intraoperative right shoulder pain and its potential impact on the need for conversion to general anesthesia.</p> <p><strong>Methods: </strong>This is a prospective comparative case series study in which 70 patients scheduled for elective laparoscopic cholecystectomy were. Patients in Group R received 1 ml (1 mg) of Hypobaric Ropivacaine 0.1% at T10-11 followed by 25 mcg fentanyl, and 5 mg Isobaric Ropivacaine 0.5% whereas patients in Group B received 1.5 ml (7.5 mg) Isobaric levo Bupivacaine 0.5% and 25 mcg fentanyl at T8-T10. Patients in both the groups were compared for incidence of shoulder tip pain and Hemodynamic stability.</p> <p><strong>Results: </strong>Both techniques achieved satisfactory anaesthesia quality, with similar results in surgical anaesthesia onset. Average surgical duration was 45-75 minutes with average of 60 mins with longer durations in two cases common to both the groups. In group R there was there was no bradycardia or hypotension recorded more than 10% of preinduction vitals. Whereas in group B 2 patients had bradycardia and hypotension more than 10% of preinduction vitals.</p> <p><strong>Conclusions: </strong>The T10-11 technique using low-dose (6 mg) hypobaric ropivacaine and isobaric Ropivacaine appears to be superior in terms of shoulder tip pain, and hemodynamic stability compared to the T8-T10 technique using isobaric levo-Bupivacaine alone in higher dose.</p> Sachin Nagar Naresh Paliwal Robin Lohia Vivek Saluja Narender Dutt Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 17 23 10.18203/2349-3259.ijct20240040 The effectiveness of exercises in patients with thumb carpometacarpal osteoarthritis: a study protocol for a systematic review and meta-analysis <p><strong>Background:</strong> The thumb carpometacarpal osteoarthritis (CMC-OA) is a common musculoskeletal condition of the hand causing increased pain and significant disability. Although different modes of exercises are usually prescribed during the management of the condition, the evidence for their effectiveness is sparse. The aim of this protocol is to investigate through a systematic review the effectiveness of exercises compared with other non-surgical interventions in reducing pain and improving function in the management of the thumb CMC-OA.</p> <p><strong>Methods:</strong> We will conduct this systematic review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. PubMed, CINAHL, EMBASE, PEDro, ScienceDirect, Cochrane Library, Grey literature databases and clinical trial registries will be searched. Two reviewers will independently evaluate the retrieved results. Subsequently, data extraction of the eligible trials will be conducted by two independent researchers. We will use the grading of recommendations assessment, development, and evaluation (GRADE) approach to assess the certainty of evidence.</p> <p><strong>Conclusions: </strong>This systematic review will provide evidence for the clinical benefits of exercises compared with other conservative interventions in the management of patients with thumb CMC-OA.</p> <p><strong>Trial registration: </strong>PROSPERO registration number is CRD42023461505<strong>.</strong></p> Stefanos Karanasios Dimitra Mertyri Fotis Karydis Copyright (c) 2023 International Journal of Clinical Trials 2023-12-27 2023-12-27 11 1 24 28 10.18203/2349-3259.ijct20233941 Evaluation of Estonia’s enhanced care management program: protocol for a cluster randomized trial <p><strong>Background: </strong>Estonia’s aging population faces an increasing burden of non-communicable diseases (NCDs) and a growing population suffers with multiple chronic conditions. These changes have reduced well-being and quality of life for many older Estonians, while increasing the use of high cost specialist and emergency care. In response, the Estonia Health Insurance Fund (EHIF) is working to support primary care physicians to improve care for complex patients with multiple chronic conditions. A new EHIF program, Enhanced Care Management (ECM), trains family physicians to identify complex patients, co-develop proactive care plans with them, and conduct more active outreach and management of these patients.</p> <p><strong>Methods:</strong> In this protocol we describe a randomized controlled trial, developed in partnership with EHIF, to evaluate the impact of ECM training for physicians. The RCT enrolled a randomly selected 97 family physicians out of the 786 family physicians practicing in Estonia. Among those physicians’ 6,739 ECM-eligible patients, 2,389 patients were randomly selected for enrolment into the ECM program.</p> <p><strong>Results:</strong> Using administrative records, we evaluated the effects of ECM enrolment on: (1) health care utilization; (2) provider management of tracer conditions; and (3) markers of quality of care such as hospital admission for primary health care-sensitive conditions.</p> <p><strong>Conclusions:</strong> This protocol presents a pre-specified analysis plan for this evaluation of Estonia’s ECM program.</p> <p><strong>Trial registration:</strong> First registered with the American Economics Association, AEARCTR-0003661. Registered May 1, 2019. Retrospective secondary registration with P169891. Registered April 26, 2023.</p> Benjamin Daniels Daniel Rogger Meyhar Mohammed Katre Vaarsi Kevin Croke Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 29 38 10.18203/2349-3259.ijct20240041 The hypoalgesic effects of wrist extensors training with blood flow restriction in patients with lateral elbow tendinopathy: a study protocol for a cross-over randomized controlled trial <p><strong>Background:</strong> Lateral elbow tendinopathy (LET) is a disabling overuse injury with a significant healthcare burden. Despite the fact that exercise interventions are considered the best recommended treatment option of LET, their effectiveness in reducing pain and improving function remains debatable. The aim of our study is to evaluate the immediate effects of a new method of exercise using blood flow restriction (BFR) on pain perception and pain-free grip strength in patients with LET.</p> <p><strong>Methods:</strong> This study was designed as a cross-over randomized controlled trial. We will compare an intervention using wrist extensors training with (WET-BFR) to a control intervention using WET-without-BFR in patients with LET. All measurements will be taken by a blinded assessor pre- and post-intervention. Primary outcome measures will be the changes in pressure pain thresholds at the lateral epicondyle, extensor carpi radialis brevis, C4 vertebra and tibialis anterior. Secondary outcome measure will be the changes in pain-free grip strength ratio.</p> <p><strong>Conclusions:</strong> New approaches are needed to improve the treatment outcomes in LET. Although BFR training was found more effective in improving function and treatment success than conventional training, the effects on pain intensity were poor. Our hypothesis is that using the best BFR practice guidelines for wrist extensors training might be more effective to reduce pain sensitivity compared with non-BFR training in patients with LET. The trial will provide new research data to inform clinical practice regarding the effects of using BFR training in the current patient group.</p> <p><strong>Trial registration</strong>: University of West Attica ethics committee: 9150/01-02-2023, NCT05919914</p> Stefanos Karanasios George Gioftsos Copyright (c) 2023 International Journal of Clinical Trials 2023-11-18 2023-11-18 11 1 39 44 10.18203/2349-3259.ijct20233553 Effect of different positioning before, during and after surgery on pressure injury: a randomized controlled trial protocol <p><strong>Background:</strong> Patients undergoing surgery are at risk of developing pressure injuries because they remain immobile and in a fixed position on the operating table for a long time under anesthesia. Prevention of surgery-induced pressure injuries is the best strategy and requires risk assessment and timely implementation of preventive interventions. This trial aims to evaluate the effect of positioning in a different position pre-operatively and post-operatively than the position adopted during surgery on pressure injuries.</p> <p><strong>Methods:</strong> This trial was designed as a prospective randomized controlled study. Participants meeting the inclusion criteria will be assigned to the intervention or control groups using a random number generator. The participants in the intervention group will be placed in different positions than their surgical position during the night before surgery, and the first 36 h after surgery. The control group will receive only routine care. The groups will be evaluated in terms of pressure injury development for at least 72 h, until discharge.</p> <p><strong>Conclusions:</strong> Surgery-induced pressure injuries have important effects on patients, healthcare professionals, and healthcare organizations. Current guidelines recommend that patients be positioned in a different position preoperatively and postoperatively than the surgical position to redistribute the pressure generated during surgery. There is a need for well-designed, comprehensive studies to investigate the effectiveness of this weak evidence-level recommendation. This trial will provide valuable evidence to inform clinical practice, guide surgical nurses, and allow evaluation of the effects of this intervention.</p> <p><strong>Trial registration:</strong> Clinical trials registration number NCT05549830</p> Bedia Guler Aysel Gurkan Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 45 52 10.18203/2349-3259.ijct20240042 A randomized, placebo-controlled crossover trial to assess the influence of body weight on aspirin-triggered specialized pro-resolving mediators: protocol for the discover study <p><strong>Background:</strong> Low-dose aspirin is ineffective for primary prevention of cardiovascular events in people with body weight greater than 70kg. While the prevalent explanation for this is reduced platelet cyclooxygenase-1 (COX-1) inhibition at higher body weights, supporting data are limited, thereby demanding further investigation of the reason(s) underlying this observation. We propose that aspirin-mediated cyclooxygenase-2 (COX-2) acetylation and the resulting synthesis of 15-epi-lipoxin A<sub>4</sub>, a specialized pro-resolving mediator, is suboptimal in higher weight individuals, which may contribute to the clinical trial findings.</p> <p><strong>Methods:</strong> To test this hypothesis, we are conducting a double-blind, placebo-controlled, randomized, mechanistic crossover trial. Healthy men and women exhibiting a wide range of body weights take 81mg aspirin and 325mg aspirin for 3 weeks each, following 3-week placebo run-in and wash-out phases. Our target sample size is 90 subjects, with a minimum of 72 completing all visits estimated to be necessary to achieve power adequate to test our primary hypothesis. Our primary endpoint is the difference in change in plasma 15-epi-lipoxin A<sub>4</sub> occurring with each dose of aspirin. Secondary endpoints include lipid mediator profiles, serum bioactive lipid profiles, and other endpoints involved in the resolution of vascular inflammation.</p> <p><strong>Conclusions:</strong> Study enrollment began in November 2021 and is ongoing. The results of this study will improve our understanding of the mechanisms underlying aspirin’s role(s) in the prevention of adverse cardiovascular outcomes. They may also lead to additional studies with the potential to inform dosing strategies for patients based on body weight.</p> <p><strong>Trial registration:</strong> This trial is registered with identifier NCT04697719.</p> Natalie G. McGowan Judy H. Zhong Leonardo Trasande Jason Hellmann Sean P. Heffron Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 53 60 10.18203/2349-3259.ijct20240043 Post-operative rehabilitation after surgical shoulder stabilization with Latarjet procedure: a study protocol for systematic scoping review <p><strong>Background:</strong> Anterior shoulder instability (ASI) is highly prevalent in the general population causing a significant functional decline and increased healthcare burden. Among the surgical stabilization options, the Latarjet procedure is commonly preferred to treat traumatic ASI in young active individuals. Despite the advances in surgical procedures, the research evidence regarding the content of post-operative rehabilitation programmes following a Latarjet procedure for ASI is inconclusive.</p> <p><strong>Methods:</strong> This protocol will adhere on the preferred reporting items for systemic reviews and meta-analyses extension for scoping reviews (PRISMA-ScR) and the Joanna Briggs Institute guidelines. MEDLINE, OvidSP, Embase, Cochrane Library, CINAHL, PubMed, SPORTS Discus and Scopus databases will be searched for relevant studies. Two reviewers will independently screen the results against the eligibility criteria defined by the population concept and context of this scoping review. A PRISMA-ScR flow diagram will be used to present the number of sources of evidence identified. The two reviewers will extract the data aiming to synthesize the results in appropriate tables. The most relevant details of the post-operative rehabilitation programmes will be presented based on consensus on exercise reporting template checklist.</p> <p><strong>Conclusions: </strong>This scoping review can provide critical information regarding the content of the post-operative rehabilitation programmes after shoulder stabilization with a Latarjet procedure in patients with ASI.</p> Stefanos Karanasios Sophia Zepou Nafsika Atsidakou Copyright (c) 2023 International Journal of Clinical Trials 2023-12-27 2023-12-27 11 1 61 65 10.18203/2349-3259.ijct20233942 The effectiveness of extended postpartum comprehensive health care bundle selected outcomes of women with preeclampsia at 6 months: protocol of a randomized controlled trial <p><strong>Background:</strong> Women who have experienced pre-eclampsia (PE) may also face additional health problems in later life, as the condition is associated with an increased risk of death from 2-fold increased risk of long-term cardiovascular disease (CVD), hypertension, stroke, an approximate 5-12-fold increased risk of end-stage renal disease (ESRD), metabolic syndrome, and diabetes.</p> <p><strong>Methods:</strong> Method was randomized controlled trial. Women with PE who delivered in PGIMER will be enrolled and will be allocated into experimental ad control group using a computer random table with allocation concealment. Enrolment will be done at the time of discharge; baseline assessment will be done 6 weeks and the intervention bundle will be implemented to the women in experimental group. The women in control group will receive routine care. Women in both the groups will be followed up at 6 months.</p> <p><strong>Conclusions:</strong> This study aims to determine the effectiveness of “extended postpartum comprehensive health care bundle (EP CHC bundle)” on selected outcomes of women with preeclampsia at 6 months. The comprehensive health care bundle will be designed with the inputs from all stakeholders, has the potential to suit the dynamic nature of management of women with preeclampsia after delivery.</p> <p><strong>CTRI registration number:</strong> CTRI/2021/04/032749 ON 12/4/2021</p> Venkadalakshmi V. Manju Dhandapani Shalini Gainder Vikas Suri Karobi Das Rajesh Vejeyvergiya Abhishek Ghosh Poonam Khanna Rajan Chellappa Babina Copyright (c) 2024 International Journal of Clinical Trials 2024-01-24 2024-01-24 11 1 66 72 10.18203/2349-3259.ijct20240044