International Journal of Clinical Trials最新文献_第4页

Post-operative rehabilitation after surgical shoulder stabilization with Latarjet procedure: a study protocol for systematic scoping review 用拉塔杰特手术稳定肩关节后的术后康复：系统性范围研究的研究方案

International Journal of Clinical Trials Pub Date : 2023-12-27 DOI: 10.18203/2349-3259.ijct20233942

S. Karanasios, Sophia Zepou, Nafsika Atsidakou

{"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}

引用次数: 0

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 肘外侧肌腱病患者腕关节伸肌训练与血流限制的镇痛效果：交叉随机对照试验的研究方案

International Journal of Clinical Trials Pub Date : 2023-11-18 DOI: 10.18203/2349-3259.ijct20233553

S. Karanasios, G. Gioftsos

{"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}

引用次数: 0

The efficacy of combining low-level laser therapy with oral motor exercises in patients with temporomandibular disorders (pilot study) 低水平激光联合口腔运动训练治疗颞下颌疾病的疗效观察(初步研究)

International Journal of Clinical Trials Pub Date : 2023-10-23 DOI: 10.18203/2349-3259.ijct20233170

Ali M. Alqahtani, Mai S. Almohaya, Nezar S. Al Torairi, Lubna M. Al Otaibi

{"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}

引用次数: 0

Evaluation of method of cohort research articles using Q-coh assessment tool 用Q-coh评价工具评价队列研究文章的方法

International Journal of Clinical Trials Pub Date : 2023-10-23 DOI: 10.18203/2349-3259.ijct20233172

Praveena Babu, Srividya A., Suresh T.

{"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}

引用次数: 0

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 CetuxIMAX方案:一项非介入、非对照、非比较的多中心研究，旨在探索西妥昔单抗在头颈癌患者中的药代动力学/药效学关系

International Journal of Clinical Trials Pub Date : 2023-10-23 DOI: 10.18203/2349-3259.ijct20233175

Clemence Marin, Joseph Ciccolini, Bruno Lacarelle, Pascal Auquier, Sebastien Salas

{"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}

引用次数: 0

Prevalence of high risk pregnancy and study of maternal and perinatal outcome 高危妊娠的流行及孕产妇和围产期结局的研究

International Journal of Clinical Trials Pub Date : 2023-10-23 DOI: 10.18203/2349-3259.ijct20233171

Shuchi Sharma, Reena Sharma, Ankush Gautam

{"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}

引用次数: 0

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 ınformation关于虚拟现实眼镜的手术室环境对患者焦虑水平和生命体征的影响:一项随机对照研究方案

International Journal of Clinical Trials Pub Date : 2023-10-23 DOI: 10.18203/2349-3259.ijct20233173

Serpil Cagliyan Payas, Nuray Sahin Orak

引用次数: 0

Screening for coronary artery disease using primary evaluation with coronary CTA in aviation medicine (SUSPECT): study design 航空医学应用冠状动脉CTA初步评价筛查冠状动脉疾病(嫌疑犯):研究设计

International Journal of Clinical Trials Pub Date : 2023-10-23 DOI: 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

{"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}

引用次数: 0

The efficacy of ranolazine in improving glycemic parameters in patients with type 2 diabetes mellitus: a meta-analysis 雷诺嗪改善2型糖尿病患者血糖参数的疗效:一项荟萃分析

International Journal of Clinical Trials Pub Date : 2023-09-16 DOI: 10.18203/2349-3259.ijct20232853

Oliver Allan C. Dampil, Sybil Claudine R. Luy, Bayocot Jayson De Lara, Rojo Rialyn, Tingchuy Avilyn Raquel

{"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}

引用次数: 0

Integration of clinical research and medical care, slow but continuing effective future 整合临床研究和医疗护理，缓慢但持续有效的未来

International Journal of Clinical Trials Pub Date : 2023-09-04 DOI: 10.18203/2349-3259.ijct20232828

Pranali M. Wandile

引用次数: 0