Comparative Evaluation of the Effectiveness of Innovative Periorbital Eye Massager and Virtual Reality Eyeglasses for Reducing Dental Anxiety during Dental Restorative Procedures in Children.

Background: Many behavior management techniques are employed to reduce the anxiety associated with dental procedures in children. One of the most commonly used methods comprises audiovisual distraction using virtual reality (VR) eyeglasses. In this study, an innovative device, a periorbital eye massager (PEM), is compared with VR to evaluate dental anxiety in children. Materials and methods: in this study, 22 children were divided into two groups, that is, group I consisting of PEM and group II consisting of VR. The participants were instructed to wear the device and then subjected to dental restorative procedures. After completion of the procedure, anxiety was measured using a validated questionnaire by the children and by using the modified behavior pain scale by the second investigator. Also, physiological parameters like heart rate and oxygen saturation were evaluated before and after a dental procedure. Results: The results were statistically insignificant for group I and group II when a validated questionnaire and modified behavior pain scale were used to measure the dental anxiety of children. Also, the data also shows no significant difference in heart rate and oxygen saturation between the two groups. Conclusion: The innovative PEM can also be used as an effective behavior management tool in managing dental anxiety in children, as there was no statistically significant difference between PEM and VR. Clinical significance: As a pediatric dentist, the methods for administering a patient present a novel challenge because behavior management varies from patient to patient. As a result, the prospects for augmenting various techniques of behavior therapy for pediatric patients are limitless. How to cite this article: Gala UP, Kalaskar R. Comparative Evaluation of the Effectiveness of Innovative Periorbital Eye Massager and Virtual Reality Eyeglasses for Reducing Dental Anxiety during Dental Restorative Procedures in Children. Int J Clin Pediatr Dent 2024;17(1):48-53.

Transcutaneous auricular vagus nerve stimulation for post-stroke depression: A double-blind, randomized, placebo-controlled trial.

BACKGROUND: It is a well-established fact that post-stroke depression (PSD) is a prevalent condition that affects a significant proportion of individuals who have suffered a stroke. Hence, our research endeavors to explore the safety, efficacy and the potential molecular mechanism of transcutaneous auricular vagus nerve stimulation (ta-VNS) for the treatment of depression in PSD patients by conducting a double-blind, sham-controlled, randomized trial. METHODS: Patients who had experienced strokes and exhibited depressive symptoms, with a Hamilton Depression Scale (HAMD-17) score of ≥8 and met the DSM-IV criteria, were diagnosed with PSD. A volunteer sample of participants (N = 80) were randomly divided into either the ta-VNS group (which received ta-VNS in addition to conventional treatment) or the control group (which received conventional treatment only), in a 1:1 ratio. The effectiveness of the interventions was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD-17), Zung Self-Rating Depression Scale (SDS), and Barthel Index (BI) scores. Furthermore, Plasma BDNF, CREB1, and 5-HT levels were measured before and after treatment. RESULTS: The concomitant application of ta-VNS demonstrated a remarkable reduction in HAMD-17 and SDS scores, leading to noteworthy enhancements in patients' daily functioning, as evidenced by improved activities of daily living, at all assessed time points, in contrast to the control group (p < 0.0001). Notably, the ta-VNS group exhibited superior effects in modulating the measured neurotrophic biomarkers when compared to the control group (p < 0.05). CONCLUSIONS: The synergistic approach of combining ta-VNS with conventional treatment has demonstrated remarkable efficacy and tolerability in managing depression following a stroke.

Efficacy and safety evaluation of Ginkgo biloba dropping pill (GBDP) on stable angina pectoris complicated with depression: A placebo-controlled, randomized, double-blind, multicenter study.

BACKGROUND: Stable angina pectoris (SAP) is a clinical condition characterized by reversible and temporary myocardial ischemia and hypoxia. A majority of SAP patients also experience depressive disorders, which adversely affect their disease prognosis and overall quality of life. However, the clinical utility of existing antidepressants is constrained by their side effects. Ginkgo biloba dropping pill (GBDP), a Chinese patented medication, has demonstrated efficacy in the treatment of both coronary heart disease and mental disorders. This prospective, randomized, double-blind, multicenter clinical trial aimed to assess the effectiveness and safety of GBDP as an adjuvant therapy for SAP complicated by depression. METHODS: Participants were randomly assigned in a 1:1 ratio to receive either GBDP or a placebo (5 pills, three times a day) in addition to standard therapy for a duration of 12 weeks. The Seattle Angina Questionnaire (SAQ) was administered every 4 weeks during the treatment, and angina event frequency was assessed weekly. The 36-item Short-Form (SF-36) and Hamilton Depression Scale (HAMD) scores were measured both before and after the treatment. RESULTS: Out of the 72 patients, 68 (n = 34 per group) completed the entire study. At the first visit (4 weeks ± 3 days), the SAQ-Angina Stability score in the GBDP group was significantly higher than that in the placebo group (p < 0.05). While the average weekly frequency of angina episodes in the placebo group notably increased after 12 weeks of treatment (p < 0.05), it displayed an improving trend in the GBDP group (p > 0.05). By the endpoint, each subcategory score of SF-36 in the GBDP group exhibited significant improvement compared to baseline (p < 0.05). The comparison of score improvement between the two groups revealed that the SF-PCS score of the GBDP group was higher than that of the placebo group (p < 0.05). HAMD scores in both groups significantly increased after treatment (p < 0.05). No discernible difference in the incidence of adverse reactions was observed between the two groups (p > 0.05). CONCLUSION: In patients with SAP complicated by depression, GBDP, when combined with standard treatment, rapidly and safely alleviates angina pectoris symptoms. It demonstrates therapeutic potential in enhancing the quality of life and alleviating depressive symptoms.

Therapy effect of cochleural alternating acoustic beam therapy versus traditional sound therapy for managing chronic idiopathic tinnitus patients.

Idiopathic tinnitus is a common and complex disorder with no established cure. The CAABT (Cochleural Alternating Acoustic Beam Therapy CAABT), is a personalized sound therapy designed to target specific tinnitus frequencies and effectively intervene in tinnitus according to clinical tinnitus assessment. This study aimed to compare the effectiveness of the CAABT and Traditional Sound Therapy (TST) in managing chronic idiopathic tinnitus. This was a randomized, double-blind, parallel-group, single-center prospective study. Sixty adult patients with tinnitus were recruited and randomly assigned to the CAABT or TST group in a 1:1 ratio using a computer-generated randomization. The treatment lasted for 12 weeks, and participants underwent assessments using the tinnitus handicap inventory (THI), visual analog scale (VAS), tinnitus loudness measurements, and resting-state functional magnetic resonance imaging (rs-fMRI). Both groups showed significant reductions in THI scores, VAS scores, and tinnitus loudness after treatment. However, CAABT showed superiority to TST in THI Functional (p = 0.018), THI Emotional (p = 0.015), THI Catastrophic (p = 0.022), THI total score (p = 0.005) as well as VAS score (p = 0.022). More interesting, CAABT showed superiority to TST in the changes of THI scores, and VAS scores from baseline. The rs-fMRI results showed significant changes in the precuneus before and after treatment in both groups. Moreover, the CAABT group showed more changes in brain regions compared to the TST. No side effects were observed. These findings suggest that CAABT may be a promising treatment option for chronic idiopathic tinnitus, providing significant improvements in tinnitus-related symptoms and brain activity.Trial registration: ClinicalTrials.gov:NCT02774122.

Repeated local delivery of hyaluronic acid gel as adjunctive treatment of residual pockets in periodontitis patients undergoing supportive periodontal care. A randomized controlled clinical trial.

OBJECTIVES: To assess the effect of hyaluronic acid (HyA) application as adjunct to re-instrumentation of residual pockets in patients undergoing regular supportive periodontal care (SPC). METHODS: Chronic periodontitis patients (stage III and IV, grade B and C) with 4 interproximal residual pockets were randomly assigned to the test (HyA gel) or control (saline) group. After subgingival instrumentation, test or control substance was applied subgingivally, then daily supragingivally for 3 months, and if required a second time after subgingival re-instrumentation after 3 months. Clinical and patient reported outcome parameters were recorded every 3 months for 12 months. Pocket closure [probing pocket depth (PPD) ≤ 4mm with absence of bleeding on probing (BoP) at PPD = 4mm] was the main outcome parameter. RESULTS: Fifty-six patients (221 experimental sites) were analysed. Pocket closure was achieved in 56.8 and 46.6% of the experimental sites in the test and control group, respectively (p > 0.05), while median PPD and PPD distribution (< 5mm/5mm/ > 5mm) differed significantly between groups in favour of the test group, at 12 months. Further, significantly fewer sites in the HyA group required re-instrumentation at 3 months, and sites in the HyA group showed a tendency for lower odds to remain diseased compared to the control group (OR 0.48, 95%CI 0.22-1.06). The odds for a site to remain diseased after 12 months increased significantly in the presence of plaque (OR 7.94, 95%CI 4.12-15.28), but in general, decreased significantly over time (OR 0.48, 95%CI 0.28-0.81). CONCLUSION: Re-instrumentation of residual pockets in SPC patients, per se, leads to a significant increase in pocket closure over time; this was impeded by poor plaque control. Repeated local application of HyA results in fewer sites requiring re-instrumentation and might slightly improve the rate of pocket closure. (clinicaltrials.gov registration nr. NCT04792541). CLINICAL RELEVANCE: HyA gel is easy to apply, well accepted by patients, and may have some positive effect in terms of fewer sites requiring re-instrumentation at 3 months and higher pocket closure rate at 12 months.

Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a double-blinded randomized controlled multicenter clinical trial.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN. METHODS: This study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment. DISCUSSION: This study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect. TRIAL REGISTRATION: ClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].

Dynamic salivary cytokine profile of recurrent aphthous stomatitis patients in thalidomide maintenance treatment.

OBJECTIVE: To dynamically compare the longitudinal (time axis) and transverse (between groups) differences of the salivary cytokines during thalidomide maintenance treatment of recurrent aphthous stomatitis. METHODS: A randomized, controlled, clinical trial was performed. After the initial prednisone treatment, thalidomide (50 mg/d vs. 25 mg/d) was used as a maintenance drug for 4 or 8 weeks. The salivary IL-4, 5, 6, 10, TNF-α, and IFN-γ were dynamically detected with a cytometric bead array. RESULTS: Overall, the level of six elevated salivary cytokines after prednisone treatment was significantly downregulated, remained low during thalidomide maintenance, and rebounded at recurrence. The effect of 50 mg/d thalidomide on the salivary cytokines was not superior to 25 mg/d medication. The relapse-free period following drug withdrawal was the longest in the subgroup using 25 mg/d thalidomide for 8 weeks. The order of magnitude of IL-6 was the most obvious, and at week 8, only the level of IL-6 in the group (25 mg/d thalidomide for 8 weeks) continued to decline compared with the other groups. CONCLUSION: Thalidomide maintenance treatment can effectively sustain low levels of salivary IL-4, 5, 6, 10, TNF-α, and IFN-γ of recurrent aphthous stomatitis patients. IL-6 displayed a good correlation with the disease and is expected to become an index for diagnosis and follow-up. CLINICAL RELEVANCE: Low-dose long-term thalidomide maintenance treatment was supported for recurrent aphthous stomatitis. TRIAL REGISTRATION: Trial registration number of ChiCTR-IPR-16009759 at http://www.chictr.org/index.aspx .

Randomized controlled multi-centre study comparing shorter dental implants (6 mm) to longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 10-year data.

AIM: To compare implant survival and complication rates between shorter and standard-length implants with sinus augmentation and restored with single crowns, at 10 years of loading. MATERIALS AND METHODS: One-hundred and one patients (137 implants) with a ridge height of 5-7 mm in the posterior maxilla were randomly assigned to two treatment modalities: shorter implants (6 mm) (group short [GS]) or standard-length implants (11-15 mm) with sinus grafting (group graft [GG]). Following the insertion of final restorations, patients were regularly recalled for up to 10 years. Assessed outcomes encompassed implant survival, marginal bone levels (MBLs), biological and technical parameters and patient-reported outcome measures (OHIP-49 = Oral Health Impact Profile). Non-parametric statistical analysis was used to analyse the data. RESULTS: For the 5- to 10-year follow-up period, 77 patients with 105 implants (GS: 36 patients/48 implants; GG: 41/57) were available for re-examination (drop-out rate 21%). Implant survival rates at the patient level were 96.0% (GS; 2 failures) and 100% (GG) (inter-group p = .24). Median MBLs amounted to 0.00 mm (min 0.00; max 3.25; GS) and 0.00 mm (min 0.00; max 4.55; GG) (inter-group p = .73). Technical complications predominantly occurred within the first 5 years (inter-group p > .05). Peri-implantitis rates were 4.2% (GS) and 13.3% (GG) (intergroup p = .37). Median OHIP-49 scores were 7.00 (0.00; 39.00; GS) and 9.00 (0.00; 196; GG) (inter-group p = .61) at 10 years. CONCLUSIONS: Based on similar 10-year implant survival rates, reduced patient morbidity and lower costs, the use of shorter dental implants might well serve as an alternative treatment concept to longer implants placed in conjunction with sinus grafting for patients with a limited ridge height in the posterior maxilla. Study register: https://clinicaltrials.gov/ct2/show/NCT01030523.

The efficacy of hypnosis compared with the tell/show/do technique for the reduction of anxiety/pain in children undergoing pulpotomies: a randomized controlled trial.

Anxiety/pain is a combined experience that can hinder dental treatment in children and lead to the development of negative behaviours in any form of surgical treatment. Hypnosis is a suitable option with which to reduce anxiety and pain during dental treatment. In this study, we aimed to evaluate the efficacy of hypnosis compared to the tell/show/do technique for the reduction of anxiety and pain as measured by Face, Legs, Activity, Crying, Consolability (FLACC) scale in children undergoing pulpotomies. We performed a randomized and controlled clinical trial involving 60 children aged 5 to 7 years without previous dental experiences but with clinical and radiographic indications for pulpotomy in the primary mandibular right or left first or second molar. The children were divided into two groups: a control group (treated by conventional behaviour management techniques) and an experimental group (treated by hypnosis). The FLACC scale was used to evaluate anxiety/pain during preoperative, transoperative and postoperative pulpotomy treatment; we also analysed variations in heart rate and skin conductance. The trial was registered at ClinicalTrials.gov (NCT03739346). Statistical analysis was performed in R Studio version 1.2.1335. The FLACC scale was significantly lower in the experimental group (p = 0.022) throughout the entire treatment duration. In addition, heart rate and global skin conductance were both significantly lower in the experimental group when measured at different times (p = 0.005 and p = 0.032, respectively). When compared to conventional behavioural management techniques, the FLACC scale demonstrated that hypnosis was associated with significant reductions in heart rate, skin conductance and anxiety/pain throughout the entire duration of treatment. decreases anxiety/pain during the entire operative procedure. There was clear improvements in anxiety and pain control in patients receiving hypnotic therapy.

Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.

BACKGROUND: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. METHODS/DESIGN: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. CONCLUSIONS: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Nil.

Effect of denture adhesives on masticatory performance: Multicenter randomized controlled trial.

PURPOSE: The purpose of this study is to investigate the effects of denture adhesives on masticatory performance via a 10-center, parallel, randomized, controlled trial of complete denture wearers in Japan. METHODS: The trial was conducted between September 2013 and October 2016. The inclusion criteria were complete edentulism, willingness to undergo new complete denture treatment, and willingness to return for recall treatment. The exclusion criteria were age 90 years or older, presence of severe systemic illness, inability to understand the questionnaires, wearing metal base complete dentures, denture adhesive user, wearing prosthetics for maxillofacial defects, wearing complete dentures with tissue conditioners, and severe xerostomia. Randomization of the powder-type denture adhesive (powder), cream-type denture adhesive (cream), and control (saline) groups was performed using a sealed envelope system. Masticatory performance was measured using color-changeable chewing gum. Intervention blinding was not feasible. RESULTS: Sixty-seven control, 69 powder, and 64 cream participants are analyzed using the intention-to-treat principle. The participants in all groups show significantly improved masticatory performance at post-intervention (paired t-test with Bonferroni correction P < 0.0001). However, no significant difference in masticatory performance is detected among the three groups (one-way analysis of variance). A significant negative correlation between pre- and post-changes in masticatory performance and intraoral condition scores is observed (Pearson's correlation coefficient, P < 0.0001). CONCLUSIONS: Although denture adhesives improved the masticatory performance of complete denture wearers, their clinical effects are comparable to those of saline solution. The use of denture adhesives is more effective in complete denture wearers with unsatisfactory intraoral conditions.

Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial).

BACKGROUND: Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post-surgery. METHOD: Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described. RESULTS: The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar. CONCLUSIONS: The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made.

Effects of Oral Cryotherapy on Anticipatory, and Acute Nausea and Vomiting in Patients With Breast Cancer Undergoing Adjuvant Chemotherapy: A Randomized Controlled Clinical Trial.

PURPOSE: To determine the effects of oral cryotherapy (OC) on the anticipatory, and acute nausea and vomiting of patients with breast cancer who are receiving adjuvant chemotherapy. PATIENTS AND METHODS: Seventy eligible patients with breast cancer were assigned to 2 groups by stratified randomization. This parallel grouped, randomized, clinical trial used the ice application protocol. OC application for an intervention group (IG, n = 35) was performed in 3 stages: i) instructions on by the investigator at the hospital; ii) the implementation accompanied by the investigator at the hospital; iii) the individual application of at home by patients. The IG had been doing the application for 12 weeks. The patients in the control group (CG, n = 35) received standard care. Additionally, Rhodes Index of Nausea Vomiting, and Retching, and EORTC QLQ-C30 Life Quality Index were conducted on the first (T1 = cycle 1 day 0), second (T2 = cycle 2 day 21), third (T3 = cycle 3 day 42), and fourth (T4 = cycle 4 day 63) cycles of adjuvant chemotherapy. RESULTS: The anticipatory nausea scores in the T2 and T4, IG were significantly lower than the CG (P < .05). In the T3, all symptom sub-dimensions except symptom occurrence (t = -0,48; P = .63) of the IG were significantly lower than those of the CG (P < .05). In the T1, T2, T3, and T4, acute nausea, acute vomiting, acute retching, and anticipatory retching scores, were significantly lower than the CG (P < .05). CONCLUSION: OC alone was effective and safe for the treatment of nausea and vomiting. The results of this study showed the clinical applicability of OC in the management of nausea and vomiting.

Eficacia y seguridad del supositorio Proctokinasa® en el tratamiento de la enfermedad inflamatoria pélvica aguda

Introducción: La enfermedad inflamatoria pélvica aguda es una entidad frecuente en mujeres jóvenes en edad reproductiva, y constituye la causa principal de infertilidad. La búsqueda de un tratamiento antiinflamatorio eficaz y seguro que alivie el dolor, evite complicaciones y secuelas, es una prioridad para su tratamiento. Objetivo: Evaluar la eficacia y seguridad del tratamiento con Proctokinasa® en la enfermedad inflamatoria pélvica aguda grados I y II. Materiales y métodos: Se desarrolló un ensayo clínico, controlado, abierto, de enero de 2017 a enero de 2018, que incluyó 76 pacientes con diagnóstico de enfermedad inflamatoria pélvica aguda en la atención primaria de salud, quienes fueron asignadas aleatoriamente a dos grupos de tratamiento: grupo principal Proctokinasa®, que recibió una unidad/8 h por 2 días, y el grupo Piroxicam, un supositorio de 20 mg/24 h por 7 días. La antibioticoterapia oral recomendada se inició simultáneamente. Se evaluó la respuesta clínica y ecográfica al tratamiento. Los eventos adversos fueron evaluados. Resultados: Se constató respuesta clínica a partir de las 72 horas de tratamiento en más del 50 % de las pacientes en ambos grupos, y fue del 100 % de los casos para el grupo Proctokinasa® en las dos últimas evaluaciones realizadas (días 10 y 15). Se evidenció la remisión de las alteraciones ecográficas en el 96,9 % del grupo Proctokinasa®. Los eventos adversos fueron escasos y leves. Conclusiones: El empleo de Proctokinasa® resultó eficaz y seguro en el tratamiento de la enfermedad inflamatoria pélvica aguda grados I y II.

Introduction: Acute pelvic inflammatory disease is a common entity in young women of reproductive age and it is a leading cause of infertility. The search for an effective and safe anti-inflammatory treatment that relieves pain, avoids complications and sequels, it is priority for its treatment. Objective: To evaluate the efficacy and safety of the treatment with Proctokinasa® in acute pelvic inflammatory disease grades I and II. Materials and methods: An open, controlled clinical trial was carried out from January 2017 to January 2018 which included 76 patients diagnosed with acute pelvic inflammatory disease in primary health care; they were randomize assigned to two treatment groups: Proctokinasa® main group, who received one unity/8h for 2 days, and the Piroxican group, 1 suppository of 20 mg/24h per 7 days. The recommended oral antibiotic therapy was started simultaneously. Clinical and ultrasound response to treatment were evaluated. Adverse events were evaluated. Results: Clinical response was stated after 72 hours of treatment inmore than 50% of the patients in both groups, and it was 100% for the Proctokinasa® group in the last two evaluations (days 10 and 15). Remission of ultrasound alterations was evident in 96.9% of the Proctokinasa® group. Adverse events were few and mild. Conclusions: The use of Proctokinasa® was effective and safe in the treatment of acute pelvic inflammatory disease grades I and II.

Circadian rhythm-based cancer therapy in randomised clinical trials.

INTRODUCTION: Since the 2017 Nobel Prize awarded to J. Hall, M. Rosbash and M.W. Young for their discoveries of molecular mechanisms behind the biological clock, circadian rhythm-based therapy, also known as chronotherapy, is receiving more attention in oncology and the number of anatomical sites of interest in this field is increasing. This observation is in line with the clinical evidence provided by trials on head and neck, lung, colorectal and cervical cancers, as well as the presently ongoing chronotherapy trials for breast and brain cancers. AREAS COVERED: The aim of this review was to collate all randomized trials conducted on chronotherapy for various tumor sites and to appraise the evidence for chrono-oncology to advance personalized therapy. Relevant literature was collected from Pubmed/Medline databases and from clinicatrials.gov. EXPERT OPINION: Current randomized clinical trials offer a certain level of evidence for the potential of chronotherapy to personalize oncologic treatment. However, comparison of trial results is hindered by the differences in timing of radiation/chemotherapy, the absence of harmonized recommendations for treatment outcome evaluation and not ultimately, the general lack of considering gender as a matched variable in trials, which was found to be a powerful factor influencing response to treatment.

The effects of intermittent fasting diet in comparison with low-calorie diet on lipid profile, glycemic status, and liver fibrosis in patients with non-alcoholic fatty liver (NAFLD): a study protocol for a randomized controlled clinical trial.

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a common liver disease characterized by an increase in fat in liver cells. The outbreak of NAFLD is estimated to be 32.4% worldwide, with higher rates in Asia and Iran. Nutritional factors such as excessive calorie intake, high fructose intake, copper deficiency, and increased iron intake play an important role in NAFLD. Since there is no specific treatment for NAFLD, intermittent fasting (IF) diet has been suggested as an alternative treatment for obesity and related complications. Previous studies showed the potential positive effects of IF on metabolic health and the reduction of oxidative stress in NAFLD. This randomized controlled trial (RCT) will be aimed to examine the effect of the IF diet in comparison with a low-calorie diet (LCD) on lipid profile, glycemic status, and liver fibrosis in patients with NAFLD. METHODS AND ANALYSIS: This is a parallel randomized clinical trial conducted on 52 overweight and obese patients with NAFLD. Participants will be randomly assigned to receive either 16:8 IF (fasting from 8 P.M. to 12 P.M. the next day) or a low-calorie (55% carbohydrate- 30% fat, 15% protein) diet for 12 weeks. Anthropometric measurements, liver assessments, and metabolic evaluations will be assessed before and after the intervention. Primary outcomes include liver steatosis and fibrosis, while secondary outcomes include liver function enzymes, insulin resistance, lipid profile, and anthropometric measurements. DISCUSSION: Since obesity and insulin resistance are the most important risk factors of NAFLD, and there is no treatment for it, it seems that lifestyle changes such as low caloric diet like IF and exercise can improve lipid metabolism and liver enzymes. TRIAL REGISTRATION: Iranian registry of clinical trials (IRCT20170202032367N5).

Efficacy of Transcranial Direct Current Stimulation (tDCS) on Cognition, Anxiety, and Mobility in Community-Dwelling Older Individuals: A Controlled Clinical Trial.

Transcranial direct current stimulation (tDCS) has gained popularity as a method of modulating cortical excitability in people with physical and mental disabilities. However, there is a lack of consensus on its effectiveness in older individuals. This study aimed to assess the efficacy of a 2-month tDCS program for improving physical and mental performance in community-dwelling older individuals. In this single-blinded, controlled clinical trial, forty-two participants were allocated to one of three groups: (1) the tDCS group, which received, twice a week, 20 min sessions of 2 mA electric current through electrodes placed on the dorsolateral prefrontal cortex; (2) the tDCS-placebo group, which underwent the same electrode placement as the tDCS group but without actual electric stimulation; and (3) the cognitive-control group, which completed crossword puzzles. Main outcome measures were cognition, mobility, and anxiety. Multivariate analyses of variance were employed. Significance was set at 5% (p < 0.05). Regarding the results, no significant benefits were observed in the tDCS group compared with the tDCS-placebo or cognitive-control groups for cognition (p = 0.557), mobility (p = 0.871), or anxiety (p = 0.356). Cognition exhibited positive oscillations during the assessments (main effect of time: p = 0.001). However, given that all groups showed similar variations in cognitive scores (main effect of group: p = 0.101; group × time effect: p = 0.557), it is more likely that the improvement reflects the learning response of the participants to the cognitive tests rather than the effect of tDCS. In conclusion, a 2-month tDCS program with two sessions per week appears to be ineffective in improving physical and mental performance in community-dwelling older individuals. Further studies are necessary to establish whether or not tDCS is effective in healthy older individuals.

Expanded nursing roles to promote person-centred care for people with cognitive impairment in acute care (ENROLE-acute): study protocol for a controlled clinical trial, process and economic evaluation.

BACKGROUND: For people with cognitive impairment, hospitalisation is challenging and associated with adverse events as well as negative outcomes resulting in a prolonged hospital stay. Person-centred care can improve the quality of care and the experience of people with cognitive impairment during hospitalisation. However, current care processes in German hospitals are rarely person-centred. To enable successful implementation of person-centred care on hospital wards, change agents within the interprofessional team are key. The aim of this study is to test the feasibility and initial effects of a newly developed complex person-centred care intervention for people with cognitive impairment provided by expanded practice nurses in acute care. METHODS: We will conduct an exploratory non-randomised controlled clinical trial with accompanying process and cost evaluation with three intervention and three control wards at one university hospital. The person-centred care intervention consists of 14 components reflecting the activities of expanded practice nurses within the interprofessional team on the intervention wards. The intervention will be implemented over a six-month period and compared with optimised care on the control wards. We will include people aged 65 years and older with existing cognitive impairment and/or at risk of delirium. The estimated sample size is 720 participants. The primary outcome is length of hospital stay. Secondary outcomes include prevalence of delirium, prevalence of agitation, sleep quality, and person-centred care. We will collect patient level data at six time points (t1 admission, t2 day 3, t3 day 7, t4 day 14, t5 discharge, t6 30 days after discharge). For secondary outcomes at staff level, we will collect data before and after the intervention period. The process evaluation will examine degree and quality of implementation, mechanisms of change, and the context of the complex intervention. The economic evaluation will focus on costs from the hospital's perspective. DISCUSSION: The ENROLE-acute study will provide insights into the effectiveness and underlying processes of a person-centred care intervention for people with cognitive impairment provided by expanded practice nurses on acute hospitals wards. Results may contribute to intervention refinement and evidence-based decision making. TRIAL REGISTRATION: Current controlled trials: ISRCTN81391868. Date of registration: 12/06/2023. URL: https://doi.org/10.1186/ISRCTN81391868.

Efficacy of curcumin gel as an adjunct to scaling and root planing on salivary procalcitonin level in the treatment of patients with chronic periodontitis: a randomized controlled clinical trial.

THE AIM OF THE STUDY: To evaluate the effect of curcumin gel combined with scaling and root planing (SRP) on salivary procalcitonin in periodontitis treatment. MATERIALS AND METHODS: seventy patients were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, and sixteen patients were excluded. Patients in groups II and III included stage II grade A periodontitis. The participants were classified into three groups: group I as a negative control group (individuals with healthy gingiva), group II (SRP) were treated with SRP, and group III (curcumin gel) which was applied weekly for four weeks after SRP. Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)) and saliva samples for procalcitonin (PCT) assessment using an enzyme-linked immunosorbent assay (ELISA) test were collected and measured at both baselines and after six weeks. RESULTS: This randomized controlled clinical trial registered on ClinicalTrials.gov (NCT05667376) and first posted at 28/12/2022 included Fifty-four patients (20 male; 34 female). Regarding the age and sex distribution, there was no statistically significant difference between the three studied groups (p > 0.05). There was no significant statistical difference regarding PI, GI, PPD, and CAL between group II and group III at baseline p (> 0.05). However, there was a significant statistical difference regarding the clinical parameters at baseline of both group II and group III as compared to group I (p ≤ 0.05). At six weeks after treatment, group III showed greater improvement in the PI, PD, and CAL as opposed to group II (p ≤ 0.05). Regarding PCT values, at baseline, there wasn't a statistically significant difference between group II and group III (p > 0.05). However, there was a significant statistical difference between group II, group III, and group I (p ≤ 0.05). At six weeks after treatment, there was a statistically significant decrease in PCT levels of both group II and III (p ≤ 0.05). CONCLUSION: The application of curcumin gel was found to have a significant effect on all clinical indices as opposed to SRP.

The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study.

BACKGROUND AND AIMS: NX-13 activation of NLRX1 reduces intracellular reactive oxygen species and decreases inflammation in animal models of colitis. A phase 1a trial demonstrated a gut-selective pharmacokinetic (PK) profile with good tolerability. This phase Ib study aimed to evaluate the safety, tolerability, and PK of NX-13 in patients with active ulcerative colitis (UC). METHODS: We conducted a multicenter, randomized, double-blinded, placebo-controlled trial of NX-13 in patients with active UC. Patients with a Mayo Clinic Score of 4-10 were randomly assigned (3:3:3:1 ratio) to three NX-13 oral dose groups (250mg Immediate Release (IR), 500mg IR, or 500mg Delayed Release (DR) or placebo) once daily for 4 weeks. Safety and PK were the primary and secondary objectives, respectively. RESULTS: Thirty-eight patients (11 females) were recruited and randomized to placebo (5), NX-13 250mg IR (11), NX-13 500mg IR (11), or NX-13 500mg DR (11) and received at least one dose. There were no Serious Adverse Events (SAEs) or deaths during the trial. One patient (500mg DR, 1/11) withdrew for worsening of UC and a second (500mg IR, 1/11) on the last day of treatment after a panic attack associated with atrial fibrillation. In the efficacy population (36 patients), clinical improvement in rectal bleeding and stool frequency scores relative to placebo were seen as early as week 2 and endoscopic response was seen at week 4. CONCLUSIONS: NX-13 was generally safe and well tolerated with early signs of rapid symptom and endoscopic improvement. This novel mechanism of action warrants further investigation. ClinicalTrials.gov: NCT04862741.