International Journal of Clinical Trials

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

2023-06-15T08:22:41+0530

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.

Screening for coronary artery disease using primary evaluation with coronary CTA in aviation medicine (SUSPECT): study design

2023-07-27T08:22:37+0530

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.

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

2023-09-05T15:10:31+0530

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.

Safety and efficacy of Placida® (fixed dose combination of flupentixol 0.5 mg and melitracen 10 mg) in comparison to escitalopram 10 mg and clonazepam 0.5 mg in patients with comorbid anxiety and depression: a randomized, double blind, double dummy, parallel group clinical trial

2023-07-28T15:46:57+0530

Background: Individuals with major depressive disorder (MDD) commonly present with comorbid anxiety and have greater depressive illness severity and chronicity, more suicide attempts, and completions. This randomized, double blind, double dummy, parallel-group clinical phase IV trial (CTRI/2022/11/047050) is aimed to compare the safety and efficacy of Placida^® (FDC of flupentixol 0.5 mg + melitracen 10 mg) versus escitalopram + clonazepam in patients with comorbid anxiety and depression.

Methods: This is a randomized, controlled, double blind, double dummy, parallel-group, phase IV trial. A total of 440 patients was enrolled across 11 sites in India who fulfilled the inclusion and exclusion criteria. All the subjects will be followed up for 2, 4, 6, 8, 10, 12, 16, 20, and 24 weeks with a buffer period of 1 week in each visit. The patient will be checked for severity of adverse events (AEs) and serious adverse events (SAEs). Efficacy will be assessed using the Hamilton depression rating scale (HAM-D), Hamilton anxiety rating scale (HAM-A) at baseline, weeks 4, 8 and 16, 24 score-reduction rate from baseline to end of treatment and extrapyramidal symptom rating scale (ESRS) at week 16 and end of the study. The first enrolment was done on 26 November 2022 and presently the subjects are under follow-up stage. The anticipated completion date for the study is March 2024.

Conclusions: Outcomes of this trial will provide valuable information on safety and efficacy of Placida^® as compared to escitalopram and clonazepam in treating patients with comorbid anxiety and depression.

Trial Registration: The trial is registered with clinical trial registry India (CTRI/2022/11/047050) prospectively.

The efficacy of ranolazine in improving glycemic parameters in patients with type 2 diabetes mellitus: a meta-analysis

2023-07-05T08:03:05+0530

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.

The efficacy of combining low-level laser therapy with oral motor exercises in patients with temporomandibular disorders (pilot study)

2023-07-21T19:33:42+0530

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.

Prevalence of high risk pregnancy and study of maternal and perinatal outcome

2023-05-11T13:09:12+0530

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.

Evaluation of method of cohort research articles using Q-coh assessment tool

2023-07-13T10:38:02+0530

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.

Integration of clinical research and medical care, slow but continuing effective future

2023-08-20T13:45:10+0530

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.