Pub Date : 2023-12-27DOI: 10.18203/2349-3259.ijct20233942
S. Karanasios, Sophia Zepou, Nafsika Atsidakou
Background: 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. Methods: 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. Conclusions: 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.
背景：肩关节前侧不稳定（ASI）在普通人群中非常普遍，会导致功能显著下降，增加医疗负担。在各种手术稳定方案中，Latarjet 手术通常是治疗活跃的年轻人创伤性 ASI 的首选。尽管手术方法在不断进步，但关于Latarjet手术治疗人工肩关节置换术后康复计划内容的研究证据尚无定论。方法：本研究将遵循系统综述和荟萃分析扩展报告的首选报告项目（PRISMA-ScR）以及乔安娜-布里格斯研究所（Joanna Briggs Institute）的指导方针。将在 MEDLINE、OvidSP、Embase、Cochrane Library、CINAHL、PubMed、SPORTS Discus 和 Scopus 数据库中检索相关研究。两名审稿人将根据本范围界定综述的人群概念和背景所定义的资格标准对结果进行独立筛选。将使用 PRISMA-ScR 流程图来显示所确定的证据来源的数量。两位审稿人将提取数据，并将结果汇总到适当的表格中。在就运动报告模板清单达成共识的基础上，将介绍术后康复计划中最相关的细节。结论：该范围界定综述可为 ASI 患者使用 Latarjet 手术稳定肩关节后的术后康复计划内容提供重要信息。
{"title":"Post-operative rehabilitation after surgical shoulder stabilization with Latarjet procedure: a study protocol for systematic scoping review","authors":"S. Karanasios, Sophia Zepou, Nafsika Atsidakou","doi":"10.18203/2349-3259.ijct20233942","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233942","url":null,"abstract":"Background: 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. Methods: 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. Conclusions: 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.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"93 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139153900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-18DOI: 10.18203/2349-3259.ijct20233553
S. Karanasios, G. Gioftsos
Background: 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. Methods: 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. Conclusions: 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. Trial registration: University of West Attica ethics committee: 9150/01-02-2023, ClinicalTrials.gov: NCT05919914
背景：肘外侧肌腱病（LET）是一种致残性的过度劳损，给医疗保健带来沉重负担。尽管运动干预被认为是治疗肘外侧肌腱病的最佳推荐方案，但其在减轻疼痛和改善功能方面的效果仍有待商榷。我们的研究旨在评估一种使用血流限制（BFR）的新锻炼方法对 LET 患者疼痛感和无痛握力的直接影响。研究方法本研究设计为交叉随机对照试验。我们将对 LET 患者进行腕部伸肌训练（WET-BFR）干预与不使用 WET-BFR 的对照干预进行比较。干预前后的所有测量均由盲人评估员进行。主要结果指标是外侧上髁、桡骨外展肌、C4椎体和胫骨前方压力痛阈值的变化。次要结果指标为无痛握力比值的变化。结论：需要新的方法来改善 LET 的治疗效果。虽然与传统训练相比，BFR 训练在改善功能和治疗成功率方面更为有效，但对疼痛强度的影响较差。我们的假设是，与非 BFR 训练相比，使用最佳 BFR 实践指南进行腕部伸肌训练可能会更有效地降低 LET 患者的疼痛敏感度。该试验将为临床实践提供新的研究数据，为在当前患者群体中使用 BFR 训练的效果提供参考。试验注册：西阿提卡大学伦理委员会：9150/01-02-2023, ClinicalTrials.gov:NCT05919914
{"title":"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","authors":"S. Karanasios, G. Gioftsos","doi":"10.18203/2349-3259.ijct20233553","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233553","url":null,"abstract":"Background: 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. Methods: 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. Conclusions: 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. Trial registration: University of West Attica ethics committee: 9150/01-02-2023, ClinicalTrials.gov: NCT05919914","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"66 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139261096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.18203/2349-3259.ijct20233170
Ali M. Alqahtani, Mai S. Almohaya, Nezar S. Al Torairi, Lubna M. Al Otaibi
Background: The term temporomandibular disorders (TMDs) is used for clinical signs and symptoms affecting the masticatory muscles, temporomandibular joints (TMJs) and associated structures or both. TMDs may present clinically with facial pain in the region of the TMJs and/or muscles of mastication, limitation in mouth opening, and TMJ clicking during mastication. Treatment of TMDs includes occlusal splints, drug therapy, physiotherapy, auriculotherapy and low-level laser therapy (LLLT). Methods: Ten patients with TMD were recruited from the Oral Medicine clinics at Prince Sultan Military Medical City. The participants were randomly allocated into two equal groups. All participants attended a total of eight laser treatment sessions using a 940 nm diode laser. The deep-tissue laser hand-piece was applied perpendicular to the Temporalis muscle, Masseter muscle and TMJ region bilaterally. Patients in the second group attended physiotherapy sessions in addition to the laser sessions. Participants were evaluated for range of mandibular movement, pain, and tenderness to palpation before treatment, one-week post-treatment, and thirty days after treatment completion. Results: This study, being a pilot study, was conducted in a comparatively small number of patients. It allowed for the assessment of research feasibility, methodology, limitations, and preliminary outcomes. Moreover, variations in the response to treatment were observed between the two groups, with results of this study supporting previous findings that LLLT is an effective treatment for TMD symptoms, tenderness to palpation, as well as improving jaw functional behavior. Conclusions: Therefore, LLLT therapy may be a promising tool for the management of TMD, especially when combined with physiotherapy.
{"title":"The efficacy of combining low-level laser therapy with oral motor exercises in patients with temporomandibular disorders (pilot study)","authors":"Ali M. Alqahtani, Mai S. Almohaya, Nezar S. Al Torairi, Lubna M. Al Otaibi","doi":"10.18203/2349-3259.ijct20233170","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233170","url":null,"abstract":"Background: The term temporomandibular disorders (TMDs) is used for clinical signs and symptoms affecting the masticatory muscles, temporomandibular joints (TMJs) and associated structures or both. TMDs may present clinically with facial pain in the region of the TMJs and/or muscles of mastication, limitation in mouth opening, and TMJ clicking during mastication. Treatment of TMDs includes occlusal splints, drug therapy, physiotherapy, auriculotherapy and low-level laser therapy (LLLT). Methods: Ten patients with TMD were recruited from the Oral Medicine clinics at Prince Sultan Military Medical City. The participants were randomly allocated into two equal groups. All participants attended a total of eight laser treatment sessions using a 940 nm diode laser. The deep-tissue laser hand-piece was applied perpendicular to the Temporalis muscle, Masseter muscle and TMJ region bilaterally. Patients in the second group attended physiotherapy sessions in addition to the laser sessions. Participants were evaluated for range of mandibular movement, pain, and tenderness to palpation before treatment, one-week post-treatment, and thirty days after treatment completion. Results: This study, being a pilot study, was conducted in a comparatively small number of patients. It allowed for the assessment of research feasibility, methodology, limitations, and preliminary outcomes. Moreover, variations in the response to treatment were observed between the two groups, with results of this study supporting previous findings that LLLT is an effective treatment for TMD symptoms, tenderness to palpation, as well as improving jaw functional behavior. Conclusions: Therefore, LLLT therapy may be a promising tool for the management of TMD, especially when combined with physiotherapy.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"7 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.18203/2349-3259.ijct20233172
Praveena Babu, Srividya A., Suresh T.
Background: Clinical and evidence-based information is very important in the field of clinical sciences including speech and hearing sciences. More and More professionals are resorting to published articles for knowledge on assessment and intervention that are evidence based. Therefore, there is a need of standard evaluation methods for each type of research that is published. The aim of the study is to investigate the quality of the cohort research articles by using the assessment tool Q-coh and thereby checking the reliability of the assessment tool. Methods: The tool Q-coh developed by Jarde et al with the aim to screen the methodological quality of the primary studies with a cohort design was taken for quality assessment of cohort research articles. Q-Coh consists of 26 items and 7 inferences. Assessment was carried out by few reviewers who were blinded to the classification of quality and based on the evaluation received from the reviewers the quality of the articles were determined. Agreement analysis was done to check the proportion of agreement between the raters and reliability of the tool respectively. Results: The research findings indicate that there is a fair to substantial agreement between the raters. Further, the quality of the articles was determined and classified into the class of acceptable and good quality. Conclusions: The present study was conducted to check if the checklist Q-coh is applicable to assess the methodological quality of cohort research studies. The outcomes of the study indicate that the tool is reliable.
{"title":"Evaluation of method of cohort research articles using Q-coh assessment tool","authors":"Praveena Babu, Srividya A., Suresh T.","doi":"10.18203/2349-3259.ijct20233172","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233172","url":null,"abstract":"Background: Clinical and evidence-based information is very important in the field of clinical sciences including speech and hearing sciences. More and More professionals are resorting to published articles for knowledge on assessment and intervention that are evidence based. Therefore, there is a need of standard evaluation methods for each type of research that is published. The aim of the study is to investigate the quality of the cohort research articles by using the assessment tool Q-coh and thereby checking the reliability of the assessment tool. Methods: The tool Q-coh developed by Jarde et al with the aim to screen the methodological quality of the primary studies with a cohort design was taken for quality assessment of cohort research articles. Q-Coh consists of 26 items and 7 inferences. Assessment was carried out by few reviewers who were blinded to the classification of quality and based on the evaluation received from the reviewers the quality of the articles were determined. Agreement analysis was done to check the proportion of agreement between the raters and reliability of the tool respectively. Results: The research findings indicate that there is a fair to substantial agreement between the raters. Further, the quality of the articles was determined and classified into the class of acceptable and good quality. Conclusions: The present study was conducted to check if the checklist Q-coh is applicable to assess the methodological quality of cohort research studies. The outcomes of the study indicate that the tool is reliable.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"18 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135413340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.18203/2349-3259.ijct20233175
Clemence Marin, Joseph Ciccolini, Bruno Lacarelle, Pascal Auquier, Sebastien Salas
Background: In a previous pilot-study, a link between Cetuximab exposure levels (i.e., trough levels above 34 mg/ml) and clinical outcome in head and neck cancer patients was found. Considering the high inter-individual variability in Cetuximab plasma levels, lack of efficacy could thus be linked to inadequate exposure levels, rather than issues with signalling pathways at the tumor level. Methods: The CetuxIMAX study is a non-interventional, uncontrolled, and non-comparative multicentric study in patients with recurrent or metastatic head and neck squamous cell carcinoma, and treated by any Cetuximab-based regimen. A total of 122 patients will be enrolled in this study. The primary endpoint is the estimation of receiver operating characteristic (ROC) and area under the ROC curve (AUROC) of Cetuximab trough plasma level for the disease control rate (DCR). Pharmacokinetics samples will be collected at first cycle, when steady-state is reached, and during maintenance phase to monitor the Cetuximab levels throughout time. Standard PK modelling using population-approach will be performed to identify individual PK parameters and enable further simulations of exposure levels throughout the different cycles. Univariate and multivariable statistical analysis aiming at exploring any association between Cetuximab exposure levels and clinical outcome will be performed. Conclusions: Should the target therapeutic window associated with efficacy be confirmed with Cetuximab in head/neck cancer patients, this could pave the way for PK-guided dosing next. Based upon single point PK sampling, pop-PK modelling could help personalizing dosing or scheduling, to ensure an optimal toxicity-efficacy ratio with Cetuximab. Trial Registration: Trial registration number is NCT 04218136.
{"title":"The CetuxIMAX protocol: a non-interventional, uncontrolled, and non-comparative multicentric study for exploring the pharmacokinetics/pharmacodynamics relationships of cetuximab in head and neck cancer patients","authors":"Clemence Marin, Joseph Ciccolini, Bruno Lacarelle, Pascal Auquier, Sebastien Salas","doi":"10.18203/2349-3259.ijct20233175","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233175","url":null,"abstract":"Background: In a previous pilot-study, a link between Cetuximab exposure levels (i.e., trough levels above 34 mg/ml) and clinical outcome in head and neck cancer patients was found. Considering the high inter-individual variability in Cetuximab plasma levels, lack of efficacy could thus be linked to inadequate exposure levels, rather than issues with signalling pathways at the tumor level. Methods: The CetuxIMAX study is a non-interventional, uncontrolled, and non-comparative multicentric study in patients with recurrent or metastatic head and neck squamous cell carcinoma, and treated by any Cetuximab-based regimen. A total of 122 patients will be enrolled in this study. The primary endpoint is the estimation of receiver operating characteristic (ROC) and area under the ROC curve (AUROC) of Cetuximab trough plasma level for the disease control rate (DCR). Pharmacokinetics samples will be collected at first cycle, when steady-state is reached, and during maintenance phase to monitor the Cetuximab levels throughout time. Standard PK modelling using population-approach will be performed to identify individual PK parameters and enable further simulations of exposure levels throughout the different cycles. Univariate and multivariable statistical analysis aiming at exploring any association between Cetuximab exposure levels and clinical outcome will be performed. Conclusions: Should the target therapeutic window associated with efficacy be confirmed with Cetuximab in head/neck cancer patients, this could pave the way for PK-guided dosing next. Based upon single point PK sampling, pop-PK modelling could help personalizing dosing or scheduling, to ensure an optimal toxicity-efficacy ratio with Cetuximab. Trial Registration: Trial registration number is NCT 04218136.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"14 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.18203/2349-3259.ijct20233171
Shuchi Sharma, Reena Sharma, Ankush Gautam
Background: A high-risk pregnancy refers to pregnancy with an increased risk of adverse outcome in the mother or baby. Directing appropriate timely intervention is very important to prevent maternal and perinatal morbidity and mortality. Aim was to study the prevalence of High-risk pregnancy and to study the maternal and perinatal outcome. Methods: A record-based retrospective observational study was done from January 2022 to December 2022 among antenatal women who were admitted in the labour ward of tertiary care institute. Results: Among 3,887pregnant patients, 1126 (28.96%) were high risk pregnancies. The most common high-risk factors were hypothyroidism (15.96%), hypertensive disorder (3.31%), previous one caesarean section (2.8%). 88% high risk pregnant women had caesarean section. 96.5% neonates had APGAR score more than 7 and 1.7% neonates were admitted to NICU. There were 8 macerated and 3 fresh still births. Conclusions: Directing appropriate timely intervention is very important to prevent maternal and perinatal morbidity and mortality. In our tertiary care hospital, the prevalence of high-risk pregnancy was 28.96% and no maternal mortality.
{"title":"Prevalence of high risk pregnancy and study of maternal and perinatal outcome","authors":"Shuchi Sharma, Reena Sharma, Ankush Gautam","doi":"10.18203/2349-3259.ijct20233171","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233171","url":null,"abstract":"Background: A high-risk pregnancy refers to pregnancy with an increased risk of adverse outcome in the mother or baby. Directing appropriate timely intervention is very important to prevent maternal and perinatal morbidity and mortality. Aim was to study the prevalence of High-risk pregnancy and to study the maternal and perinatal outcome. Methods: A record-based retrospective observational study was done from January 2022 to December 2022 among antenatal women who were admitted in the labour ward of tertiary care institute. Results: Among 3,887pregnant patients, 1126 (28.96%) were high risk pregnancies. The most common high-risk factors were hypothyroidism (15.96%), hypertensive disorder (3.31%), previous one caesarean section (2.8%). 88% high risk pregnant women had caesarean section. 96.5% neonates had APGAR score more than 7 and 1.7% neonates were admitted to NICU. There were 8 macerated and 3 fresh still births. Conclusions: Directing appropriate timely intervention is very important to prevent maternal and perinatal morbidity and mortality. In our tertiary care hospital, the prevalence of high-risk pregnancy was 28.96% and no maternal mortality.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.18203/2349-3259.ijct20233173
Serpil Cagliyan Payas, Nuray Sahin Orak
Background: This article summarizes the study protocol currently used to evaluate the effect of informing about the operating room environment with virtual reality (VR) glasses on patients' anxiety level and vital signs. Methods: This study was designed as a non-drug clinical, randomized controlled trial. Eligible patients will be randomly assigned to one of two groups. The population of the study will consist of 80 patients who will undergo planned abdominal surgery in the operating room unit of a state hospital affiliated to the TRNC ministry of health. Before surgery, the first group (n=40) will be informed through VR glasses, while the second group (n=40) will receive standard care. Conclusions: The outcome is anxiety level before surgery and the state of vital signs during surgery. Trial registration: International standard randomized controlled trial number NCT05899790.
{"title":"The effect of ınformation about the operating room environment with virtual reality glasses on the anxiety level and vital findings of the patients: a randomized controlled study protocol","authors":"Serpil Cagliyan Payas, Nuray Sahin Orak","doi":"10.18203/2349-3259.ijct20233173","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233173","url":null,"abstract":"Background: This article summarizes the study protocol currently used to evaluate the effect of informing about the operating room environment with virtual reality (VR) glasses on patients' anxiety level and vital signs. Methods: This study was designed as a non-drug clinical, randomized controlled trial. Eligible patients will be randomly assigned to one of two groups. The population of the study will consist of 80 patients who will undergo planned abdominal surgery in the operating room unit of a state hospital affiliated to the TRNC ministry of health. Before surgery, the first group (n=40) will be informed through VR glasses, while the second group (n=40) will receive standard care. Conclusions: The outcome is anxiety level before surgery and the state of vital signs during surgery. Trial registration: International standard randomized controlled trial number NCT05899790.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135413336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.18203/2349-3259.ijct20233174
Erik Frijters, Remco B. Grobben, Birgitta K. Velthuis, Lysette N. Broekhuizen, Roland T. A. Beekmann, Rienk Rienks, Hendrik M. Nathoe
Background: Sudden in-flight incapacitation of aircrew may cause an airplane crash. Important causes are major adverse cardiac events, such as myocardial infarction and sudden cardiac arrest. Aircrew of the Royal Netherlands Air Force (RNLAF) are required to undergo periodic cardiac screening, including bicycle exercise-testing. Unfortunately, this modality lacks diagnostic accuracy for relevant coronary artery disease (CAD) in low-risk populations similar to military aircrew. Cardiac CT, however, comprising Coronary Artery Calcium score (CACS) and coronary CT angiography (CCTA), is able to adequately detect (subclinical) CAD with high negative predictive values in low-risk populations and may provide opportunity for early interventions. Methods: This was a prospective, single-center, cohort study of 250 military aircrew. Asymptomatic aircrew ≥40 years are asked to undergo a voluntary cardiac CT following routine aeromedical examination. Prevalence and severity of CAD will be described according to the CAD-RADS system, including coronary artery calcium score (CACS) and high risk plaque features. The primary endpoint is relevant CAD, defined as a composite of a coronary stenosis ≥50% and/or CACS >100 Agatston Units. The secondary endpoint is ‘aeromedically significant CAD’, defined by national military regulations as a left main stenosis of >30%, any luminal stenosis ≥50%, and/or an aggregate coronary stenosis of ≥120%. Conclusions: The aim is to assess the value of cardiac CT for routine aeromedical screening in asymptomatic Dutch military aircrew aged ≥40 years, in comparison to the current cardiac screening protocol which includes an exercise ECG. Trial Registration: Clinical trial registered on clinicaltrials.gov number NCT05508893.
{"title":"Screening for coronary artery disease using primary evaluation with coronary CTA in aviation medicine (SUSPECT): study design","authors":"Erik Frijters, Remco B. Grobben, Birgitta K. Velthuis, Lysette N. Broekhuizen, Roland T. A. Beekmann, Rienk Rienks, Hendrik M. Nathoe","doi":"10.18203/2349-3259.ijct20233174","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233174","url":null,"abstract":"Background: Sudden in-flight incapacitation of aircrew may cause an airplane crash. Important causes are major adverse cardiac events, such as myocardial infarction and sudden cardiac arrest. Aircrew of the Royal Netherlands Air Force (RNLAF) are required to undergo periodic cardiac screening, including bicycle exercise-testing. Unfortunately, this modality lacks diagnostic accuracy for relevant coronary artery disease (CAD) in low-risk populations similar to military aircrew. Cardiac CT, however, comprising Coronary Artery Calcium score (CACS) and coronary CT angiography (CCTA), is able to adequately detect (subclinical) CAD with high negative predictive values in low-risk populations and may provide opportunity for early interventions. Methods: This was a prospective, single-center, cohort study of 250 military aircrew. Asymptomatic aircrew ≥40 years are asked to undergo a voluntary cardiac CT following routine aeromedical examination. Prevalence and severity of CAD will be described according to the CAD-RADS system, including coronary artery calcium score (CACS) and high risk plaque features. The primary endpoint is relevant CAD, defined as a composite of a coronary stenosis ≥50% and/or CACS >100 Agatston Units. The secondary endpoint is ‘aeromedically significant CAD’, defined by national military regulations as a left main stenosis of >30%, any luminal stenosis ≥50%, and/or an aggregate coronary stenosis of ≥120%. Conclusions: The aim is to assess the value of cardiac CT for routine aeromedical screening in asymptomatic Dutch military aircrew aged ≥40 years, in comparison to the current cardiac screening protocol which includes an exercise ECG. Trial Registration: Clinical trial registered on clinicaltrials.gov number NCT05508893.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"14 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135413768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-16DOI: 10.18203/2349-3259.ijct20232853
Oliver Allan C. Dampil, Sybil Claudine R. Luy, Bayocot Jayson De Lara, Rojo Rialyn, Tingchuy Avilyn Raquel
Ranolazine is an anti-anginal drug that mediates its effects by inhibition of cardiac late sodium current. Although it is not indicated for the treatment of type 2 diabetes mellitus (T2DM), several clinical trials have shown that ranolazine was associated with a reduction in HbA1c. The objective of this meta-analysis is to determine the efficacy and safety of ranolazine in improving glycemic control in patients with T2DM. A total of five randomized controlled trials involving 2,680 patients were included in the analysis. The pooled analysis showed that ranolazine may improve glycemic control with a modest decrease in HbA1c and FBS. The difference in HbA1c was -0.38% (95% CI -0.59 to -0.17), favoring ranolazine. Sensitivity analysis showed a difference of HbA1c of -0.49% (CI -0.67, -0.31), still favoring the ranolazine group. There was also a statistically significant difference in fasting glucagon, favoring the ranolazine group (-2.70 pg/ml: 95% CI -5.24 to -0.16). The risk of hypoglycemia with ranolazine was comparable with placebo (RR 1.27 95% CI 0.84 to 1.91). Overall, ranolazine appears to be a safe and effective option for improving glycemic control in patients with T2DM, with a modest decrease in HbA1c and FBS, and a lower risk of hypoglycemia compared to placebo. However, further studies are needed to confirm these findings and to investigate the long-term safety and efficacy of ranolazine in this patient population.
雷诺嗪是一种抗心绞痛药物，通过抑制心脏晚期钠电流介导其作用。虽然它不适合治疗2型糖尿病(T2DM)，但一些临床试验表明，雷诺嗪与降低HbA1c有关。本荟萃分析的目的是确定雷诺嗪改善T2DM患者血糖控制的有效性和安全性。共纳入5项随机对照试验，涉及2680例患者。综合分析显示，雷诺嗪可以改善血糖控制，并适度降低HbA1c和FBS。HbA1c差异为-0.38% (95% CI -0.59至-0.17)，有利于雷诺嗪。敏感性分析显示HbA1c差异为-0.49% (CI -0.67， -0.31)，仍有利于雷诺嗪组。空腹胰高血糖素的差异也有统计学意义，雷诺嗪组更有利(-2.70 pg/ml: 95% CI -5.24 ~ -0.16)。雷诺嗪组发生低血糖的风险与安慰剂组相当(RR 1.27, 95% CI 0.84 - 1.91)。总的来说，雷诺嗪似乎是改善T2DM患者血糖控制的一种安全有效的选择，与安慰剂相比，HbA1c和FBS略有下降，低血糖的风险更低。然而，需要进一步的研究来证实这些发现，并调查雷诺嗪在该患者群体中的长期安全性和有效性。
{"title":"The efficacy of ranolazine in improving glycemic parameters in patients with type 2 diabetes mellitus: a meta-analysis","authors":"Oliver Allan C. Dampil, Sybil Claudine R. Luy, Bayocot Jayson De Lara, Rojo Rialyn, Tingchuy Avilyn Raquel","doi":"10.18203/2349-3259.ijct20232853","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232853","url":null,"abstract":"Ranolazine is an anti-anginal drug that mediates its effects by inhibition of cardiac late sodium current. Although it is not indicated for the treatment of type 2 diabetes mellitus (T2DM), several clinical trials have shown that ranolazine was associated with a reduction in HbA1c. The objective of this meta-analysis is to determine the efficacy and safety of ranolazine in improving glycemic control in patients with T2DM. A total of five randomized controlled trials involving 2,680 patients were included in the analysis. The pooled analysis showed that ranolazine may improve glycemic control with a modest decrease in HbA1c and FBS. The difference in HbA1c was -0.38% (95% CI -0.59 to -0.17), favoring ranolazine. Sensitivity analysis showed a difference of HbA1c of -0.49% (CI -0.67, -0.31), still favoring the ranolazine group. There was also a statistically significant difference in fasting glucagon, favoring the ranolazine group (-2.70 pg/ml: 95% CI -5.24 to -0.16). The risk of hypoglycemia with ranolazine was comparable with placebo (RR 1.27 95% CI 0.84 to 1.91). Overall, ranolazine appears to be a safe and effective option for improving glycemic control in patients with T2DM, with a modest decrease in HbA1c and FBS, and a lower risk of hypoglycemia compared to placebo. However, further studies are needed to confirm these findings and to investigate the long-term safety and efficacy of ranolazine in this patient population.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135306512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-04DOI: 10.18203/2349-3259.ijct20232828
Pranali M. Wandile
The demarcation between research and medical practice appears partly blurred as they often coexist together while still having significant differences between them. The prospective complete merger still seems to have a bright future that could benefit humankind. The goal of medical practice is to provide the diagnosis, palliative or curative therapy, preventative therapy and the term "research" is recognized as a pursuit to investigate a hypothesis and pull conclusions to develop the theory or contribute to generalizable knowledge. A clinical trial is usually described as a clinical research study protocol with certain objectives and steps to accomplish those objectives. Integrating evidence-based medicine in medical practice requires combining patient-targeted treatment and research and overcoming all possible methodological, organizational, and cultural challenges while integrating the teaching healthcare system.
{"title":"Integration of clinical research and medical care, slow but continuing effective future","authors":"Pranali M. Wandile","doi":"10.18203/2349-3259.ijct20232828","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232828","url":null,"abstract":"The demarcation between research and medical practice appears partly blurred as they often coexist together while still having significant differences between them. The prospective complete merger still seems to have a bright future that could benefit humankind. The goal of medical practice is to provide the diagnosis, palliative or curative therapy, preventative therapy and the term \"research\" is recognized as a pursuit to investigate a hypothesis and pull conclusions to develop the theory or contribute to generalizable knowledge. A clinical trial is usually described as a clinical research study protocol with certain objectives and steps to accomplish those objectives. Integrating evidence-based medicine in medical practice requires combining patient-targeted treatment and research and overcoming all possible methodological, organizational, and cultural challenges while integrating the teaching healthcare system.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80804527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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